The updated information to the drug’s WARNINGS section reinforces the Boxed Warning that was added to all metoclopramide-containing drugs in June 2009. The new warning states, “Treatment with metoclopramide can cause Tardive Dyskinesia (TD), a potentially irreversible and disfiguring disorder characterized by involuntary movements of the face, tongue, or extremities. The risk of developing Tardive Dyskinesia increases with the duration of treatment and the total cumulative dose. An analysis of utilization patterns showed that about 20 percent of patients who used metoclopramide took it for longer than 12 weeks. Treatment with metoclopramide for longer than the recommended 12 weeks should be avoided in all but rare cases where therapeutic benefit is thought to outweigh the risk of developing TD.”

Metozolv, as well as all metoclopramide-containing medications, are only available by prescription. Metoclopramide is approved for the treatment of severe heartburn and acid reflux, gastroesophageal reflux disease (GERD), and gastroparesis, or delayed emptying of stomach contents. It is also used off-label to treat morning sickness. Many patients who require metoclopramide have difficulty swallowing. Metozolv is the first metoclopramide treatment available in an orally disintegrating tablet.

SOURCE: Reglan Side Effects › Metozolv label has new tardive dyskinesia warning

The study looked at nearly 841,000 births registered with national databases from 1996 to 2008. In about 5,000 cases, the mothers had taken PPIs at some point during the four weeks prior to pregnancy through their first trimester. Overall, 3.4 percent of the babies whose mothers took PPIs had a major birth defect, compared to 2.6 percent of babies whose mothers did not take the drugs. Researchers said this difference was not significant enough to cause alarm.

However, the study showed that women who took PPIs in the four weeks leading up to pregnancy had a 39 percent greater risk of having a baby with major birth defects. The study’s authors dismissed the findings as biologically implausible as the medication generally does not stay in the body for more than a few hours.

The study does raise questions about the safety of heartburn medications during pregnancy. Gastrointestinal problems are one of the most common side effects with pregnancy. In some cases, over-the-counter medications cannot quell nausea and vomiting, raising the mother’s risk for dehydration and other serious problems.

Some doctors have turned to prescribing Reglan (metoclopramide). While the drug is not approved by the FDA for use during pregnancy, it has been prescribed for off-label use.  Some foreign studies suggest it does not raise a woman’s risk for having a baby with birth defects. The drug, however, carries a black box warning of the risk of developing a serious involuntary movement disorder called Tardive Dyskinesia.

SOURCE: Reglan Side Effects › Heartburn drugs before pregnancy may increase risk for birth defects

Reglan, also known by the generic metoclopramide, is a prescription medication used to treat severe heartburn, acid reflux, gastroparesis and other gastrointestinal problems. Last year, after numerous reports to the Food and Drug Administration (FDA) of patients who took the drug and then developed Tardive Dyskinesia, the FDA ordered that a black box warning be placed on Reglan. The label now warns against long-term use – 12 weeks or greater.

The condition is marked by involuntary movements of the muscles and can include lip smacking, tongue thrusting, eye blinking and bulging, head jerking, facial grimacing, puckering and pursing of the lips, and involuntary movements of the fingers. In some cases, it can cause involuntary movements of the legs. Tardive Dyskinesia is debilitating and oftentimes the symptoms do not subside even after the medication has been stopped.

Hundreds of lawsuits have been filed against people who developed the serious movement disorder after taking Reglan or one of its generic equivalents. They say that the makers of the drug were fully aware of the dangers it could cause but they did nothing to warn patients or their doctors until thousands were already suffering from the condition.

SOURCE: Reglan Side Effects › Restless leg syndrome turns out to be movement disorder caused by Reglan

Metoclopramide is approved by the Food and Drug Administration (FDA) to treat severe heartburn, gastroesophageal reflux disease (GERD), and gastroparesis. Last year, the federal agency ordered a black box warning be placed on the drug following reports of a debilitating, involuntary movement disorder known as Tardive Dyskinesia most often associated with long term (greater than 12 weeks) use of the drug. The drug also carries warnings on its safety label of anxiety, depression and suicidal ideation.

Most physicians do not like to prescribe medication to expectant mothers because of concerns of how the drug will affect the unborn child. But as much as 80 percent of pregnant women suffer from morning sickness in the first trimester. For most, the nausea can be managed with small, frequent meals, but for some women, morning sickness can last well past the first trimester putting the mother and baby both at risk from dehydration and lack of nutrition. In such cases, some doctors have turned to off-label prescribing of various medications, including metoclopramide.

Metoclopramide is more commonly used off-label as a treatment for morning sickness in Europe and Israel, but the practice is beginning to carry over to the United States even though there have been no studies backing up the safety of the drug on pregnant women and their unborn children.

But, a new Israeli study, reported in the New England Journal of Medicine, studied a total of 81,703 births among mothers enrolled in Israel’s largest HMO, 3,458 of whom used metoclopramide during their pregnancy. The study showed that there were no significant increases in the incidence of birth defects or low birth weight in the group using metoclopramide, and there was even a slightly lower incidence of stillbirth.

Researchers say the findings provide reassurance regarding the safety of metoclopramide for the fetus when the drug is given to women to relieve nausea and vomiting during pregnancy. However, women who take the drug – whether pregnant or not – should use care and heed the label’s safety warnings as the drug can cause serious, even life-threatening, problems.

SOURCE: Reglan Side Effects › Reglan as morning sickness treatment still carries risks for mom

“Looking back, mother started noticing gradual changes in his behavior after his doctor prescribed Reglan for heartburn associated with a hiatal hernia,” she wrote. “We have done some research and found that this drug can indeed cause depression, confusion and even suicide. We were unaware of this side effect when Daddy was taking Reglan.

“Why don’t doctors and pharmacists warn patients about this deadly reaction?” she asked.

Nearly 20 years later, people are still asking why they weren’t adequately warned about the risk of depression, anxiety and suicidal ideation associated with Reglan. Such side effects are listed on the drug’s label, but the adverse event most people are aware of is the black box warning on the drug that advises against long-term use of Reglan because of the risk of a serious and involuntary movement disorder known as Tardive Dyskinesia.

“Although some doctors and pharmacists do an excellent job of alerting their patients to the potential side effects of medication, others may overlook or discount psychological reactions,” Joe Graedon and Dr. Teresa Graedon with People’s Pharmacy responded. “As your father’s example shows too clearly, that can be a fatal error.”

The two warn that a surprising number of medicines, including some commonly prescribed for blood pressure, Parkinson’s disease and digestive problems can adversely affect emotional imbalance. Insomnia, anxiety, confusion, personality changes or depression may come on so slowly that the patient doesn’t link it to the drug he is taking.

SOURCE: Reglan Side Effects › People feared link between Reglan and suicide 20 years ago

But mothers need to be aware that the drug has serious side effects. KellyMom.com, a breastfeeding and parenting blogger, warns that one major side effect of Reglan is depression, a condition that tends to be more prevalent in new mothers. “It is contraindicated in moms with a history of depression, and all moms who take this should keep an eye out for signs of depression,” she writes. “It has caused serious depression/anxiety in moms regardless of previous history. This depression side effect usually develops over 3-4 weeks, and goes away if mom discontinues the Reglan.”

Laura, a lactation specialist, responded to the post in hopes of warning unsuspecting women of this possible side effect:

“First, you should know that I am a lactation consultant, I recently gave birth to my fourth child and despite my training and knowledge, I was in need of a galactogogue. I opted for Reglan upon consultation with my physician and despite a history of mild depression.

“After taking the medication for approximately 6 weeks, I decided it was time to taper off of the medication. Within 48 hours of my last dose, I began to suffer from severe anxiety and eventually even had one panic attack. I have never had any problems with, or history of anxiety or panic attacks in my life and as the result of an in-depth assessment by an anxiety disorder specialist, it was determined that this development was directly related to my use of Reglan.

“This experience was absolutely horrible! I was bed ridden for 10 days and it took a total of three weeks for me to recover completely. Subsequently, my milk supply suffered substantially from the physical insult. I have since, however, been able to recover it partially only after arduous pumping and retraining of my baby to take the breast once again.

“As a lactation consultant, I will be happy to educate my clients on the use of this drug, but I will never again recommend it myself.”

SOURCE: Reglan Side Effects › Women warn new mothers of Reglan’s depression risk

Harris’ lawsuit, on behalf of her minor child, claims the defendants “encouraged the long term use of these drugs, and concealed the drug’s dangerous side effects.” Last year, the Food and Drug Administration (FDA) ordered that a black box warning be placed on Reglan (metoclopramide) warning against long term use (greater than 12 weeks) of the drug because of the risk of Tardive Dyskinesia. Harris’ lawsuit claims the defendants were well aware of the drug’s serious side effects but failed to adequately warn users of the risk.

“Defendants breached these warranties (both express and implied) as the Reglan/metoclopramide was not merchantable, was unfit for its intended use and was unreasonably dangerous when comparing the benefits to the risks associated with its use,” the complaint states.

Harris’ lawsuit is filed against Pharmaceutical Associates, Beach Products, Morton Grove Pharmaceuticals, and Wockhardt. Harris is seeking damages for medical expenses, physical pain and suffering, mental anguish, physical disfigurement, physical impairment, loss of earning capacity, pre- and post-judgment interest and court costs.

SOURCE: Reglan Side Effects › Woman blames Reglan for causing her young child permanent disability

Joe became sedentary. He lacked motivation to do any physical activity, became increasingly tired, slept excessively, and refused to interact with others. His treating physician considered a slew of other diagnoses from Parkinson’s to Parkinson’s with atypical depression pattern to early dementia. He was referred to a neurologist, who determined that Joe’s symptoms were most likely secondary to his Reglan use, and that the patient was significantly depressed and needed psychiatric follow-up. Yet, there was no mention that Joe was suicidal and needed protection. Nine months after starting continuous daily use of Reglan, Joe committed suicide by gunshot to the chest.

Did Reglan cause Joe’s severe depression that lead to his suicide? The question was raised and Joe’s case was studied in a recent issue of The Internet Journal of Gastroenterology.

The current prescribing information for Reglan (metoclopramide) includes a warning that states, “Mental depression has occurred in patients with and without prior history of depression. Symptoms have ranged from mild to severe and have included suicidal ideation and suicide. Metoclopramide should be given to patients with a prior history of depression only if the expected benefits outweigh the potential risks.”

Another aggravating factor for Joe is that the class of antidepressants he was prescribed, selective serotonin reuptake inhibitors (SSRIs) can cause suicidal ideation as well. Likely, these drugs aggravated his metoclopramide-induced depression. And the result was deadly.

“It is imperative that prescribing physicians remain informed and aware of as wide a pattern, as possible, of potential serious and severe adverse effects of the medications they prescribe,” the paper concludes. “Warnings to patients and their families that new or worsening symptoms can represent adverse effects of prescribed medications, rather than a progression of the underlying disease state, can be life-saving.”

* Names were changed

SOURCE: Reglan Side Effects › Medical journal studies case of Reglan-induced depression, suicide

“My life is unbearable because of Reglan, and if the side effects don’t end soon, I am afraid that I will eventually kill myself,” writes Jodi* on Medications.com bulletin board. “I took Reglan for a month. I gradually began to lose interest in things, couldn’t concentrate, and at the very end of the month became suicidal. It has now been a month since I have stopped taking Reglan, and every day is miserable and joyless. Everyday I cry and think about suicide. The side effects of this medication did not end when I stopped taking it.”

Bobby is also suspicious of Reglan. He wonders if his wife’s suicide was triggered by the drug. “My wife started taking Reglan last year, one week before she committed suicide at the age of 57,” he wrote on Medications.com. “She had never been diagnosed in her life as depressed.”

Reglan’s safety label carries a host of side effects, including the black box warning for Tardive Dyskinesia. Under the “important warnings” section, it also mentions side effects such as “depression” and “thinking about harming or killing yourself.” Perhaps its time for the FDA to issue another black box warning for its popular heartburn drug.

SOURCE: Reglan Side Effects › Reglan users blame depression, suicidal thoughts on heartburn drug

Tardive Dyskinesia is an involuntary movement disorder that causes repetitive movements of the face and limbs. These movements include lip smacking, grimacing, tongue protusion, rapid eye movements or blinking, puckering and pursing of the lips, or impaired movements of the fingers. It is a debilitating condition whose symptoms often do not go away even after the offending medication has been stopped.

Metoclopramide was originally used to treat psychosis in patients, but the drug showed more promise in controlling gastrointestinal disorders and is now largely used for this purpose. Neuroleptic drugs like metoclopramide, which also includes anti-psychotic drugs, have been associated with movement disorders and other serious side effects since the 1990s.

In 2000, Cisapride, another anti-psychotic drug that was also released as a gastrointestinal medication, was discontinued after it was found to cause cardiac complications in patients treated with the medication. This likely delayed the reporting of adverse events associated with metoclopramide.

Until the black box warning was issued earlier this year, metoclopramide safety labels indicated Tardive Dyskinesia was a rare side effect and did not warn against long-term use of the drug. In the interim, doctors freely prescribed the drug without knowledge of the serious problems it could cause over time. As a result, hundreds of people have filed suit against the makers of metoclopramide claiming they were not adequately warned of the dangers of taking the heartburn medication.

SOURCE: Reglan Side Effects › Long-term use of heartburn drug can cause serious movement disorder

For several months, Gentrie was unable to eat solid food, and in at least one occasion was rushed to the hospital for her severe vomiting and dehydration. It wasn’t until she was had a CAT scan that doctors finally discovered the cause of her painful condition. Gertie was diagnosed with pediatric gastroparesis, a condition in which the stomach takes too long to empty its contents. Gastroparesis is often associated with diabetic patients. Doctors believe Gertie’s condition was triggered by a virus.

There are few treatments for severe gastroparesis. It is often treated with medications such as the prescription drug Reglan, also known as the generic metoclopramide. But Reglan carries a risk of severe side effects, especially with long-term use. The drug now carries a black box warning of the risk of developing a neurological disorder known as Tardive Dyskinesia in which the muscles move involuntarily.

Gertie was treated with various medications, including Botox, but nothing seemed to help. She was even fitted with a gastric tube to help her gain weight, but her frail body rejected it six times. As a last resort, doctors decided on a new treatment, implanting in her a gastric pacemaker that would trigger her stomach muscles to contract and encourage digestion.

With the help of singer Miley Cyrus, Gentrie’s family raised enough money to cover the cost of the pacemaker. It was implanted in July and just last week, Gentrie was finally able to have her first meal in eight months. What did she choose to eat? A Wendy’s hamburger.

SOURCE: Reglan Side Effects › Teenager finally finds relief from gastroparesis

Hundreds of people who have been harmed by Reglan have already filed lawsuits against the manufacturers of the drug. Reglan is approved by the FDA to treat chronic heartburn and acid reflux as well as diabetic gastroparesis, or delayed emptying of the stomach contents. The agency placed a black box warning on the drug after numerous reports of people taking the drug developing a debilitating involuntary movement disorder known as tardive dyskinesia. The condition causes symptoms such as lip smacking, tongue thrusting, eye blinking and bulging, head jerking, facial grimacing, puckering and pursing of the lips, and involuntary movements of the fingers. In many cases, the symptoms do not go away even if the medication has been stopped.

Reglan is available by the brand name or generics as metoclopramide. Its various formulations include tablets, syrups, injections and oral disintegrating tablets. An estimated 2 million people use some form of Reglan. Individuals who believe they are suffering from complications from Reglan are encouraged to talk to an attorney, as they may be entitled to compensation.

SOURCE: Reglan Side Effects › Time is running out for victims of Reglan to file lawsuits

Essential tremors is a slowly progressive neurological disorder that is most recognized by tremors of the arms during voluntary movements such as eating and writing. Essential tremors may also occur in the head or neck, jaw and voice as well as other body regions. It is not unlike tardive dyskinesia, another neurological disorder that causes involuntary movements of the muscles and can include lip smacking, tongue thrusting, eye blinking and bulging, head jerking, facial grimacing, puckering and pursing of the lips, and involuntary movements of the fingers.

The heartburn medication Melissa was prescribed, Reglan, also known by the generic name metoclopramide, has a black box warning on its safety label stating that patients taking the drug are at risk for developing the movement disorder.

“I am so sorry to hear you have tremors,” Gina responded to Melissa. “I was on Reglan … and I heard all the awful reports about tardive dyskinesia. Did you know that people are now suing for damages because of this drug? Look on the Internet. It’s full of ads of lawyers and warnings about this rotten drug that needs to be removed from the market.”

Gina is correct. In fact, hundreds of lawsuits have been filed against the makers of metoclopramide from people who are suffering from tardive dyskinesia and claim they were not adequately warned that they could develop the condition. Tardive dyskinesia is debilitating. There is no known cure, and the symptoms often linger even after the medication has been stopped. Those who have filed lawsuits say they would never have taken the drug if they knew it would harm them.

SOURCE: Reglan Side Effects › Doctor: woman’s ‘essential tremors’ caused by heartburn drug Reglan

Symptoms of GERD include heartburn, or a burning sensation under the breastbone, burning in the back of the throat due to regurgitation of stomach acid, nausea and vomiting. If left untreated, GERD can result in painful inflammation or ulcers in the esophagus, scar tissue in the esophagus, Barrett’s esophagus, cough and asthma, inflammation and infection in the lungs, inflammation of the throat and larynx, and even fluid in the sinuses and middle ears.

Currently, there are few safe and effective treatments for GERD, and some prescription medications to treat the condition, such as Reglan (metoclopramide) now carry a black box warning by the Food and Drug Administration (FDA) for side effects that include the risk of developing tardive dyskinesia, a neurological disorder that causes involuntary movements of the muscles in the face, arms and torso.

In order to qualify for the medical study, participants must be 18 to 65 years of age and currently be taking an FDA-approved dose of heartburn medication. Qualified participants will receive lab work, study related medical care and medication, and $600 for completion of the study.

For more information or to sign up for the study, visit the GERD study page at the Clinical Connection’s website.

SOURCE: Reglan Side Effects › GERD sufferers sought for study on investigational heartburn treatment

The presentation, entitled, “Ulimorelin (ghrelin agonist) effects on daily vomiting due to diabetic gastroparesis,” summarizes the effects of ulimorelin in patients with daily, moderate to severe vomiting.

Individuals with severe gastroparesis face frequent hospitalizations and emergency room admissions due to recurrent nausea and vomiting, which are often associated with dehydration, malnutrition and weight loss due to inadequate caloric food intake. Currently, there are no safe and effective treatments for gastroparesis. Prescription medications to treat the condition were either withdrawn from the market or now carry a black box warning due to serious side effects.

For example, the gastroparesis drug Reglan (metoclopramide) has side effects that include the risk of developing tardive dyskinesia, a neurological disorder that causes involuntary movements of the muscles in the face, arms and torso.

Tranzyme Pharma’s new drug, ulimorelin, offers a glimmer of hope to sufferers of severe gastroparesis. The Phase 2 study of diabetic patients with advanced gastroparesis given ulimorelin intravenously once daily for four days, demonstrated clinically and statistically significant improvements in multiple gastroparesis-related symptoms, including vomiting and nausea. Patients who had moderate to severe daily vomiting during the 4-day period just prior to the start of the study also reported a marked reduction in the number of days vomiting during the 4-day treatment period.

SOURCE: Reglan Side Effects › Experimental gastroparesis drug to be presented at medical conference

Drugs are available to curb the symptoms of acid reflux, even for the youngest infants. But they should be a last resort. Some of the medications routinely given to infants, such as Reglan (metoclopramide) can have serious side effects. Reglan has been associated with a number of drug interactions and can and may increase the risk of seizures in people who have seizures.

The first remedies to try should be natural ones. For example, finding relief for your little one may be as simple as changing the way your baby is fed. Decreasing volume and increasing the frequency of feedings can sometime remedy the problem. Bottle-fed babies can sometimes be given milk or formula thickened with a small amount rice cereal. Food allergies may also be the cause of reflux. The most common culprits are milk and soy proteins in formulas. Breast-feeding mothers should also take note of the foods they consume, as cow’s milk, soy, egg, and peanuts can cause their baby to experience reflux.

Because babies can’t adjust their position, parents should sit them upright when feeding and keep them upright after feeding. Placing a wedge – available at baby supply stores – under the baby’s mattress where the head goes also helps milk follow gravity and prevent reflux.

SOURCE: Reglan Side Effects › Infant reflux: Natural remedies should be tried before medical ones

Diabetics

The study is being conducted at institutes in 37 cities in numerous states across the country. Additional criteria to participate includes being 18 years of age or older and free of cancer for five years. Qualified participants will receive all study-related exams and investigational study medication at no cost. Compensation is also provided.

Currently, there are few options for patients who suffer from the painful and often debilitating symptoms of gastroparesis. A restricted diet may help some, but many turn to medications or surgery to help them lead normal lives. However, surgery can be invasive, and even the most common medications to treat gastroparesis, such as Reglan (metoclopramide), come with an FDA black box warning that the drug has been linked to a serious and involuntary movement disorder known as Tardive Dyskinesia. There is no cure for Tardive Dyskinesia and symptoms often persist even after the medication has been stopped.

Clinical trials are medical research studies involving people. The trials look at preventing disease, treatments, diagnosing disease and controlling symptoms, and seek to determine if a new experimental drug or procedure is safe, has side effects, works better than the currently used treatment, and helps patients feel better. New treatments must be thoroughly tested first in the laboratory and then in people before they are approved by the FDA.

For more information about and locations for the nationwide Diabetic Gastroparesis Clinical Trial, visit the Clinical Connection.

SOURCE: Reglan Side Effects › Clinical trial seeks diabetics for new gastroparesis treatment

The numerous responses tell the same story. “My experience with Reglan was absolutely frightening,” says SoCal. “I developed severe Parkinson’s-like tremors and anxiety. And, I don’t even have a history of anxiety. I stopped the drug immediately and was told never to take it again.”

“I had the same experience as SoCal with Reglan,” says Natie. “I developed severe anxiety and tremors within the first day of taking it.”

“I had the same exact experiences,” Miss Lady Bug chimes in. “I stopped taking it but was left with permanent nerve damage. I had to go to Mayo Clinic to find that out,” she says. “Mayo told me that Reglan should be outlawed and that the USA is the only country that even still uses it.”

Reglan was approved by the Food and Drug Administration (FDA) for the treatment of severe heartburn, acid reflux and gastroparesis. After numerous reports of people using Reglan who then developed tardive dyskinesia, the FDA last year added a black box warning to the drug’s safety label. That warning comes too late for many users of Reglan, who are left with the disabling symptoms of tardive dyskinesia, which include lip smacking, tongue thrusting, eye blinking and bulging, and puckering and pursing of the lips, to name a few.

“I would give anything to be able to go back and do it all over again,” Miss Lady Bug says. “The trembling and anxiety was sooo bad.”

SOURCE: Reglan Side Effects › Forum discusses side effects of heartburn drug Reglan

Reglan is a medication commonly used to treat gastrointestinal conditions such as severe heartburn or acid reflux, and diabetic gastroparesis, a condition in which the stomach takes too long to empty its contents. It is indicated as a short-term therapy to be used for no more than 12 weeks. Studies have shown that long-term use of Reglan puts users at a 1-in-5 risk of developing tardive dyskinesia. The condition causes sufferers to develop symptoms such as lip smacking, tongue thrusting, eye blinking and bulging, head jerking, facial grimacing, puckering and pursing of the lips, and involuntary movements of the fingers. The condition can be permanent, continuing even after the offending medication has been stopped.

Both lawsuits claim that the drug’s manufacturers didn’t adequately warn users that they were at risk for developing tardive dyskinesia. Both Keeper and Austin are seeking damages for medical expenses, physical pain and suffering, mental anguish, physical disfigurement, physical impairment, loss of earnings, loss of earning capacity, court costs, and interest.

Reglan and the generic metoclopramide now carry an FDA boxed warning about the risk of developing the movement disorder.

SOURCE: Reglan Side Effects › Two more lawsuits filed against makers of heartburn drug Reglan

Tardive Dyskinesia is caused by the long-term use of drugs that block dopamine receptors known as dopamine-receptors antagonists or DRAs. Most of the drugs in this category are anti-psychotics used to treat schizophrenia and other mental disorders.

Recently another medication was added to the list of drugs that increase the risk of developing Tardive Dyskinesia – metoclopramide, known by the brand name Reglan. Reglan is a DRA used to treat gastrointestinal disorders ranging from nausea and heartburn to severe acid reflux and diabetic gastroparesis. Reglan now carries a Food and Drug Administration (FDA) boxed warning against long-term use of the drug because of the risk of developing Tardive Dyskinesia.

The condition can be difficult to diagnose because the medications that cause the disorder can also mask the symptoms. Coming off the offending medication can cause symptoms to surface or even improve. But for some, the debilitating symptoms can be permanent. There is no cure for Tardive Dyskinesia, but some have found relief by taking vitamin E, botulinu toxin injections or by taking certain drugs.

If you have questions about any of these medications or are concerned about symptoms you are experiencing, contact your health care professional.

SOURCE: Reglan Side Effects › Drugs that block dopamine receptors can cause Tardive Dyskinesia

Reglan was approved by the Food and Drug Administration (FDA) for the treatment of gastrointestinal conditions such as chronic heartburn, severe acid reflux or GERD, nausea, and gastroparesis. One year ago, after numerous reports of people using Reglan developed the often permanent and debilitating movement disorder, the FDA placed a black box warning on the drug warning physicians and consumers that using Reglan increased one’s risk of developing Tardive Dyskinesia. A black box warning is the strongest warning the agency can give and is reserved for drugs that carry a significant risk of serious or even life-threatening adverse effects.

But Reglan also carries under the WARNINGS AND PRECAUTIONS section of its safety label a risk of developing depression. Some cases are mild, but others can be quite severe and may involve suicidal thoughts or behaviors. Because of this, consumers should tell their health care provider if they have depression or a history of depression. People who are prescribed Reglan should also be monitored for any signs of depression.

If you or someone you know is taking Reglan and has concerns or questions about the medication, contact your health care professional. Any side effects with this or any other medication should be reported to the FDA MedWatch Adverse Event Reporting Program at www.FDA.gov/MedWatch.

SOURCE: Reglan Side Effects › Using Reglan can make you depressed

According to the complaint, Swicegood was prescribed 10 mg Reglan to be taken four times daily. Reglan is the brand name equivalent of the generic metoclopramide. Metoclopramide is made by various pharmaceutical companies but the active ingredient is the same as the name brand. Swicegood says she followed her doctor’s orders but developed Tardive Dyskinesia. Studies suggest that long-term use of metoclopramide – 12 weeks or more – puts users at a startling 20 percent greater risk of developing the condition.

Swicegood’s lawsuit is one of more than 150 that have been filed against drug makers on behalf of plaintiffs who say they were not warned of the serious side effects of metoclopramide. The first lawsuit was filed in 1998. More than a decade later – February 2009 – the Food and Drug Administration (FDA) issued a black box warning on metoclopramide alerting physicians and patients of a risk of Tardive Dyskinesia.

Last spring, the U.S. Judicial Panel on Multidistrict Litigation denied a request to consolidate the federal litigation on metoclopramide lawsuits, saying it was more appropriate for them to be heard in different courts throughout the U.S.

SOURCE: Reglan Side Effects › Reglan (metoclopramide) jury trial to begin next week

Tranzyme Pharma’s drug candidate would be an alternative to a drug for gastroparesis that now carries a black box warning. Reglan (metoclopramide) is a prescription treatment for gastroparesis that just recently received an FDA black box warning following reports that linked the medication to a serious and involuntary movement disorder known as Tardive Dyskinesia. A black box warning is the most serious type of warning the agency can issue and is reserved for drugs that carry a significant risk of serious or even life-threatening adverse events.

Alternatively, Tranzyme Pharma reported that all three doses of TZP-102 were effective, safe and well tolerated by participants in the clinical trial. The company is now gearing up for a 12-week study to test the drug’s efficacy and safety in patients who have gastroparesis.

Last month, Tranzyme Pharma announced an agreement with Netherlands-based Norgine to develop and commercialize TZP-101, another treatment for gastrointestinal disorders.

SOURCE: Reglan Side Effects › Diabetic gastroparesis treatment shows well in clinical trials

Nearly a year later, Whitener saw a television commercial about the adverse events linked to the heartburn drug Reglan. The medication had recently been hit with a black box warning after numerous reports of consumers who took Reglan and developed a serious involuntary movement disorder known as Tardive Dyskinesia. Whitener also learned that the drug was not approved by the Food and Drug Administration (FDA) for use during pregnancy, though some studies suggested it was a safe treatment for morning sickness. Whitener spoke with various health care professionals and none could rule out the possibility of Reglan causing or contributing to her son’s birth defects.

Whitener and Lucas’ father Joshua A. Whitener, Sr., both individually and on behalf of Lucas, have filed a lawsuit against Pliva Inc., Pliva USA, Pliva Pharmaceuticals Inc., Barr Laboratories, Barr Pharmaceuticals, Watson Pharmaceuticals, Teva Pharmaceuticals Industries, Teva Pharmaceuticals USA, Rue De Sante Women’s Center, and John McCrossen. The Whiteners are seeking damages for pain and suffering, permanent disabilities, fear, mental anguish, loss of love and affection, loss of companionship, grief and mental anguish, loss of society and consortium, loss of personal service, loss of support, medical expenses, lost wages, and other financial loss/detriment.

SOURCE: Reglan Side Effects › Lawsuit blames Reglan for causing son’s birth defects

Tardive dyskinesia is a disorder that causes involuntary movements, especially in the lower face. Symptoms include facial grimacing, jaw swinging, repetitive chewing and tongue thrusting. It is a serious side effect from long-term use of antipsychotic drugs as well as metoclopramide, but sometimes the condition occurs with short-term use of the medication. The condition may be reversed if it is diagnosed early and the medication is stopped; however, in many cases, the involuntary movements may be permanent and in some cases may become significantly worse.

Last year, the Food and Drug Administration (FDA) issued a black box warning on Reglan (metoclopramide) after numerous reports of consumers developing tardive dyskinesia after taking the drug. The label now warns of the risk of the disorder with long-term (12 weeks or more) use of the drug.

Bennett took Reglan (metoclopramide) as an acid reflux treatment from December 2008 to May 2009 and developed tardive dyskinesia. He claims the defendant provided inaccurate, misleading, incomplete, false and inadequate information about the risks in taking Reglan (metoclopramide). He is seeking damages for medical expenses, physical pain and suffering, mental anguish, physical disfigurement, physical impairment, loss of earnings, loss of earning capacity, court costs, and interest.

SOURCE: Reglan Side Effects › Louisiana man sues maker of acid reflux medication Reglan

When a person with a normally functioning digestive system swallows, the lower esophageal sphincter acts as a trap door by relaxing and allowing for food and liquids to move into the stomach. Then the muscle tightens, closing this door. For people who suffer from gastro-esophageal reflux disease, also known as GERD, that trap door doesn’t close all the way, or it opens too often, so the gastric acid flushes up into the food pipe. This can cause inflammation in the esophagus and bothersome burning heartburn. If this acid continues to burn the esophagus, over time it can lead to more serious issues, such as bleeding or breathing problems, and even cancer.

The molecular imaging study included 49 participants who were scanned upright with a special device that studied how their esophagus muscles and lower-esophageal sphincter were functioning. The test was then performed while patients were lying face down. While patients reported varying degrees of symptoms, almost half showed some problem with their esophagus while lying down, suggesting that abnormal esophageal motility may be the culprit in developing acid reflux.

Researchers hope these findings into the cause of GERD may lead to more drug treatments. Most acid reflux patients are treated with over-the-counter or prescription medications which can only be taken for a short period of time and can lead to serious health consequences.

SOURCE: Reglan Side Effects › Acid reflux study may lead to new treatments

Long-term use of antacids can disrupt the body chemistry. Continually reducing the amount of acid in the gastric system can, over time, cause it to produce more acid, resulting in another round of acid reflux, also known as acid rebound. But too little acid can be a problem as well. Stomach acid helps fight against substances that could harm the body and can leave the stomach more susceptible to infections.

Proton pump inhibitors, or PPIs, are the most powerful medications in the group of acid reflux treatments and overuse can cause a host of problems. For starters, the drugs can provoke underlying stomach disorders, including hyperplasia, an abnormal increase in the number of the organ cells. Another issue with PPIs surfaced just recently. Last month, the Food and Drug Administration (FDA) issued a warning to consumers and health care professionals that long term use of PPIs, both over-the-counter and prescription brands, may be linked to an increased risk of hip, wrist and spine fractures.

Perhaps the most alarming reaction to a type of acid reflux medication is a serious involuntary movement disorder known as Tardive Dyskinesia. The debilitating condition has been linked to the prescription heartburn drug metoclopramide, most commonly known by the brand name Reglan. The drug now carries a black box warning that long term use of Reglan can significantly increase one’s risk of developing the condition.

While these drugs can treat the bothersome symptoms of acid reflux, they are recommended only for short-term use. And unfortunately, once they are discontinued, as many as 80 percent of reflux-sufferers say their symptoms return within six months.

SOURCE: Reglan Side Effects › Acid reflux drugs provide temporary relief but can cause adverse reaction

In 1975, just four years before Reglan was approved by the FDA, the medical journal Gastroenterology published a study that said while the drug provided some relief of symptoms to patients with gastroesophageal reflux disease (GERD), it appeared to have no effect on serum gastrin levels. High serum gastrin levels indicate the presence of a duodenal ulcer or gastrinoma.

Eight years later, the American Journal of Gastroenterology published another study that showed Reglan provided temporary relief of GERD symptoms but did not ease symptoms of esophagitis, a condition in which the esophagus is inflamed, irritated or swollen. A third study, published in 2006 in the Nature Clinical Practice: Gastroenterology & Hepatology, found that Reglan had no sustained effect on acid exposure or in the healing of esophagitis.

If studies suggesting the ineffectiveness of Reglan don’t sway the public, perhaps the FDA’s black box warning will. The warning was issued a year ago after mounting reports of users of Reglan developing Tardive Dyskinesia. The condition can be debilitating and symptoms often do not go away after the medication has been discontinued.

Source: Huffington Post

SOURCE: Reglan Side Effects › Reglan found to be ineffective and dangerous

Reglan (metoclopramide) was approved by the Food and Drug Administration in 1979 for the short term treatment of various gastrointestinal disorders. But last year, after numerous adverse event reports, the FDA issued a black box warning – the strongest of its kind – on Reglan and generic versions of metoclopramide, stating that the medication had been linked to Tardive Dyskinesia. The movement disorder has been most often associated with some antipsychotic drugs, but about a third of the cases of Tardive Dyskinesia are linked to Reglan (metoclopramide).

An estimated two million people take metocloopramide, including children and infants. While it is approved to treat conditions such as severe heartburn, gastroesophageal reflux disease (GERD) and gastroparesis, or the delayed emptying of stomach contents, it also has an off-label use in the treatment of migraine headaches and morning sickness in women who are pregnant.

The makers of Reglan and generic versions of the drug are now facing numerous lawsuits from people like August, who are suffering permanent disability because of the drug. The Macalusoes allege they were never appropriately warned of the risk of developing Tardive Dyskinesia, and now it’s too late.

Source: News Observer

SOURCE: Reglan Side Effects › Man suffers permanent disability from heartburn drug

“I recently met a lady visiting from Iran. She has been coughing for seven years. She had seen numerous physicians and had been tested extensively in Iran. She had no word for heartburn although she described, through a translator, ‘a volcano going off in my chest,’” writes Dr. Kurt Barrett in the Battle Creek (Michigan) Enquirer. While she sat in his office, Dr. Barrett gave the woman a dose of medicine to treat GERD. She said she felt an improvement. After a week she told Dr. Barrett her nagging cough was almost completely gone. She had used no cough syrups or inhalers, just the acid reflux medication.

Another uncommon symptom of GERD is hiccups, Dr. Barrett says. “You can prove it to yourself by trying over the counter Gaviscon (an antacid that foams/floats on top of the stomach contents) for immediate relief of hiccups.”

If heartburn symptoms persist or worsen, a medical professional should be consulted. Prescription medication, such as Reglan (metoclopramide) may be necessary. Be sure to discuss with your health care professional any risks or adverse events associated with your heartburn medication.

SOURCE: Reglan Side Effects › Less common symptoms of GERD can make diagnosis difficult

Though the drugs have warning labels, the woman claims she was not adequately warned of the potential for serious side effects of the drug she was prescribed, in particular the severe movement disorder known as Tardive Dyskinesia.

Makers of generic Reglan, Teva Pharmaceuticals Industries Ltd., and Mylan Inc.’s UDL Laboratories said the lawsuit should be preempted by federal law because it would require them to write labels that stray from the brand-name drug’s label. The 8th U.S. Circuit Court of Appeals in St. Louis ruled against the generic drug makers, citing a 2009 Supreme Court decision against Pifzer Inc.’s Wyeth that said Food and Drug Administration drug regulations do not protect a drug company from being sued under state law or drug labeling. Congress could have made a provision that preempted drug-labeling lawsuits against generic drug companies but did not do so, the 8th Circuit said.

The Supreme Court is asking the U.S. Solicitor General’s office whether the Obama administration believes the court should consider the appeal.

Source: Wall Street Journal

SOURCE: Reglan Side Effects › Supreme Court considers whether generic Reglan makers can be sued

The drug trend report looked at prescription drug spending growth between 2001 and 2009 and found that prescription drug use among children has grown four times higher than the overall population. More than one in four insured kids and nearly 30 percent of adolescents (10-19 years of age) took at least one prescription medication to treat chronic conditions.

The most substantial increases were seen in the use of antipsychotic, diabetes and asthma drugs over the past nine years. But drugs to treat hypertension and gastroesophageal reflux disease, or GERD, have climbed as well. The number of children and infants taking some form of prescription heartburn medication to treat GERD or colic increased by a startling 147 percent.

How safe are these medications for children? A study published last week in The Archives of Internal Medicine shows that use of these drugs increases the risk of infection by Colstridium difficile, a harmful intestinal bacteria. And some medications can have even more dangerous side effects.

For example, the prescription drug Reglan (metoclopramide), used to treat severe heartburn and GERD in both adult and pediatric patients, carries a black box warning that long term use may cause patients to suffer from Tardive Dyskinesia, a severe movement disorder. The drug can mask symptoms of the condition, which can get worse and even linger long after the medication has been discontinued.

SOURCE: Reglan Side Effects › More children taking prescription drugs to treat chronic conditions

Wyeth and Schwarz originally developed the brand-name metoclopramide, Reglan. They were released from litigation by U.S. District Judge Marcia A. Crone. The case is expected to be ready for trial by January 2011.

Metoclopramide is a medication approved by the Food and Drug Administration (FDA) in 1989 to treat gastrointestinal conditions such as severe heartburn, gastrointestinal reflux disease (GERD) and gastroparesis, or delayed emptying of the stomach contents. Over the years, the FDA has received numerous reports of users of metoclopramide suffering from Tardive Dyskinesia, and last year the agency issued a black box warning on metoclopramide products warning users that long-term use of the drug – 12 weeks or more – considerably raised one’s risk of developing the movement disorder.

Tardive Dyskinesia is a condition in which a person develops involuntary movements of his muscles. These movements include lip smacking, tongue thrusting, eye blinking and bulging, head jerking, facial grimacing, pucker and pursing of the lips, and involuntary movements of the fingers. Symptoms often continue even after the drug has been discontinued. To date, several lawsuits have been filed in courts throughout the U.S. against the makers of Reglan and generic metoclopramide.

SOURCE: Reglan Side Effects › Generic Reglan makers released from Tardive Dyskinesia lawsuit

Researchers with Pediatrix Medical Group analyzed data from 49,777 infants born between 2003 and 2008 with a birth weight of 501-1,500 grams – or 1 to 3 pounds. The goal of the study was to determine the effectiveness of a multi-faceted quality improvement intervention in reducing the use of many medications that have not been adequately studied in this group, that have not demonstrated clinical benefits, or that carry adverse effects to neonatal patients. The medications targeted were the antibiotic cefotaxime, gastrointestinal medications metoclopramide and H-2 blockers, the diuretic spironolactone, and the hormone erythropoietin.

Metoclopramide, known by the brand name Reglan, has never been approved by the Food and Drug Administration (FDA) for use in premature infants. It is prescribed to patients to treat severe heartburn or gastroparesis, a delayed emptying of the stomach contents. The drug carries a black box warning that long-term use (12 weeks or greater) significantly increases one’s risk of a serious and debilitating movement disorder known as Tardive Diskineia.

The study compared baseline medication usage in 2003 to post-intervention usage in 2008. Following the quality improvement intervention initiatives from 2005-2007, researchers found that use of the targeted medications was significantly reduced.

SOURCE: Reglan Side Effects › Quality improvements reduce drug usage among neonatal community

Patients in the clinical trials were randomly assigned to treat their migraines with either a single dose of 900 to 1,000 milligrams of aspirin, a placebo, or an active drug, usually the prescription migraine drug sumatriptan. Researchers found that 52 percent of aspirin users got at least some pain relief – or a reduction of pain from moderate or severe to “no worse than mild” – within two hours. Only 32 percent of patients taking a placebo found relief in that time. Twenty-five percent of aspirin users reported being pain free within two hours, compared to only 11 percent of placebo users. Forty-six percent of patients who used aspirin plus 10 milligrams of metoclopramide got relief from vomiting within two hours, compared with none of those given a placebo.

Aspirin plus metoclopramide was about equally as effective in treating symptoms as a 50-milligram dose of sumatriptan, however a 100-milligram dose of sumatriptan was found to be more effective, with 28 percent of sumatriptan users reporting they were pain-free within two hours after taking the drug.

While aspirin with metoclopramide may spell relief for some, it can be dangerous if used too often. Metoclopramide is often prescribed for the treatment of gastrointestinal disorders such as GERD and gastroparesis. Long-term use of the drug – considered 12 weeks or longer – has been liked to reports of a serious movement disorder known as Tardive Dyskinesia.

SOURCE: Reglan Side Effects › Aspirin plus Reglan shows promise as migraine treatment

In that time, more and more patients were developing a serious involuntary movement disorder known as Tardive Dyskinesia. Symptoms of the condition include lip smacking, tongue thrusting, eyes blinking and bulging, head jerking, facial grimacing, puckering and pursing of the lips, and involuntary movements of the fingers. There is no known cure for Tardive Dyskinesia and the symptoms may persist even after the drug has been discontinued. The drug can also mask symptoms, aggravating them after the medicine has been discontinued.

In February 2009, the FDA issued a black box warning on Reglan and all metoclopramide products warning consumers and health care professionals that long-term use (12 weeks or more) of the drug can elevate one’s risk of developing the condition. Some studies show long-term users of Reglan were as much as 20 percent greater risk of developing Tardive Dyskinesia.

Unfortunately for Valerie, she developed Tardive Dyskinesia. Her tongue is enlarged and she can no longer speak. Even though she has discontinued her use of Reglan, the symptoms still persist.

Source: People’s Pharmacy

SOURCE: Reglan Side Effects › Long-term use of Reglan can cause serious neurological problems

In his consolidation request to the administrative director of the courts of New Jersey, Judge Codey warned that more lawsuits against the manufacturers of Reglan would likely increase in the months to come. “Cases have started coming to Essex on a weekly basis.” Plaintiffs have until May 14, 2010 to comment or object to the application for consolidation.

Reglan and its generic metoclopramide are prescribed for the treatment of gastrointestinal conditions such as severe heartburn and acid reflux, gastroesophageal reflux disease (GERD), and gastroparesis, a condition where the stomach takes too long to empty its contents. Long-tern use (12 weeks or longer) has been associated with the involuntary movement disorder Tardive Dyskinesia. Symptoms of the condition include lip smacking, tongue thrusting, eyes blinking and bulging, head jerking, facial grimacing, puckering and pursing of the lips, and involuntary movements of the fingers. There is no known cure for Tardive Dyskinesia and the symptoms may persist even after the drug has been discontinued.

All lawsuits filed against Reglan allege that the manufacturers of the drug did note adequately warn consumers of the elevated risk of Tardive Dyskinesia with taking the medication.

SOURCE: Reglan Side Effects › New Jersey judge calls for consolidation of Reglan lawsuits

“Our treatment induces collagen deposition. We create small thermal lesions which reform the lower esophageal sphincter and restore it to normal function,” Mederi CEO Will Rutan told Mass Device. “There are substantial, long-term data demonstrating high effectiveness rates and durability beyond four years, so it not only works, but it lasts.”

Curon Medical Inc., received clearance from the Food and Drug Administration (FDA) a decade ago to market the device. The company went bankrupt in 2006, paving the way for Mederi to acquire its assets. Mederi re-submitted the application for Stretta to the FDA and won clearance six months ago.

The product offers an alternative to patients who suffer from the severe acid reflux condition. GERD is often managed through diet and lifestyle changes but many require medication, such as Reglan (metoclopramide) in order to find relief. However, medications can have serious side effects.

Stretta’s target market is the 20 percent of GERD sufferers who cannot find relief through drugs or surgical intervention.

SOURCE: Reglan Side Effects › New device uses radiofrequency to offer relief to GERD sufferers

“The Food & Drug Administration’s well-known shortcomings in protecting consumers from dangerous prescription drugs have been illustrated in high-profile examples, like the recent scandal surrounding GlaxoSmithKline’s drug, Avandia, as well as Merck’s drug, Vioxx. These failures often stem from the relative weakness of the FDA as a regulatory body: overextended and underfunded, the FDA must largely rely on drug companies to police themselves,” Blizzard writes.

When it comes to generic drugs, Blizzard says the FDA’s current method is “badly flawed.” Here is why: When prescription drugs are approved by the FDA, they receive a patent, which stalls competition for a certain number of years in order for the company to recoup expenses incurred while developing the drug. During this time of free reign, the drug company must track and report adverse events and data to the FDA. Once the patent expires, competing manufacturers can market generic alternatives to the brand-name medication. These generic drug makers are required to report any adverse events or data to the FDA, but many fail to do so. In the end, it is the consumer who suffers.

For example, generic manufacturers of the acid reflux treatment Reglan (metoclopramide) failed to adequately monitor adverse events in patients taking the drug. The drug carries a risk of a serious involuntary movement disorder, Tardive Dyskinesia. Prolonged use – more than 12 weeks – raises one’s risk of developing the condition fivefold. It wasn’t until February 2009, after numerous people became ill, that the FDA issued a black box warning on Reglan and its generic alternatives.

“For too long, generic manufacturers have marketed potentially deadly products without regard for the long-term safety of their products,” Blizzard continues. “With the increased popularity of generics and the billions in additional profits that their manufacturers stand to make, this free ride must come to an end.”

SOURCE: Reglan Side Effects › Increase in availability of generic drugs may raise safety concerns

Salix Pharmaceuticals

Salix received FDA approval for Metozolv last September, offering an alternative to the metoclopramide pill known by the brand name Reglan. Reglan received a black box warning from the FDA last year after long-term (12 weeks or more) use of Reglan was linked to a serious involuntary movement disorder known as Tardive Dyskinesia.

As another version of metoclopramide, Metozolv is also required to carry the same warning on its label and provide adequate warnings of the serious side effect in its marketing materials. By not doing so, the FDA said, “these violations are concerning from a public health perspective because they suggest that Metozolv ODT is safer and more effective than has been demonstrated by substantial evidence or substantial clinical experience, and encourage use in circumstance other than those for which the drug has been shown to be safe and effective.”

However, the warning did not affect the company’s stock, which rose $1.74 last week to close at $37.41. If Salix does not correct the violations, the company could face FDA regulatory action.

SOURCE: Reglan Side Effects › Salix stock soars despite FDA warning letter

When we first told you about Mary, she was gearing up for an innovative surgery that would place a device called the Enterra into Mary’s abdomen. Her doctor, Richard McCallum, founding chair at the Paul Foster School of Medicine at Texas Tech University, called it a very powerful anti-nausea, anti-vomiting tool. For Mary, it was a glimmer of hope. “Even if my symptoms got 50 percent better, it would be a huge change in my day,” she said. 

Milder cases of gastroparesis can be treated through diet changes, however many sufferers must turn to medications such as Reglan (metoclopramide). But medication is not always an option for patients who must be on them for several months or years. Reglan has a black box warning against long-term use of the drug (more than 12 weeks) because it can cause a serious movement disorder known as Tardive Dyskinesia.

For Mary, surgery seemed to be the most logical solution.

Just days after surgery, Mary told News Channel 9 that her dreams were realized. She is able to eat and drink things she wouldn’t have even dared to try before surgery. “I’ve been eating ice cream every night, so it’s a whole new world,” she said.

SOURCE: Reglan Side Effects › Gastroparesis sufferer finds relief through surgery

The letter goes on to say that “these violations are concerning from a public health perspective because they suggest that Metozolv ODT is safer and more effective than has been demonstrated by substantial evidence or substantial clinical experience, and encourage use in circumstance other than those for which the drug has been shown to be safe and effective.”

The FDA approved Metozolv in September for the treatment of GERD, gastroparesis, and other acid reflux conditions. It is the first fast-dissolving version of metoclopramide, a drug also known by the brand name Reglan. Its projected annual sales could reach $50 million.

Last year the FDA ordered a black box warning be placed on Reglan after numerous reports of a serious involuntary movement disorder known as Tardive Dyskinesia developing in patients who took Reglan. The same black box warning was to be placed on Metozolv when it became available in the U.S. However, upon review, the FDA says Salix fell short of adequately warning patients of the risks associated with Metozolv.

The FDA is ordering Salix to immediately stop the dissemination of the violative promotional materials for Metozolv and to submit a written response to its warning letter explaining how the company will comply with the agency’s request. Failure to correct the violations could result in regulatory action, including seizure or injunction without further notice.

SOURCE: Reglan Side Effects › FDA warns makers of acid reflux drug to change warning label

Melissa Kotlen Nagin

Reglan, or metoclopramide, is a medication approved by the Food and Drug Administration (FDA) for the treatment of heartburn and GERD. It is also prescribed, off label, to help stimulate lactation, “but it is definitely not as benign as Domperidone, which carries with it virtually NO side effects,” she says.

For one, Reglan can cause depression in mothers who are already more susceptible to depression because of hormone changes following childbirth. But Reglan also carries an FDA black box warning. Long-term use of Reglan greatly increases a woman’s risk of a serious involuntary movement disorder known as Tardive Dyskinesia. The condition can be debilitating and often does not go away, and often worsens, after the medication is discontinued.

Nagin’s advice? “If you are having milk supply issues, be sure to see a lactation consultant ASAP! The longer you wait, the more intense the process to get your supply back to where it should be.”

SOURCE: Reglan Side Effects › Lactation specialist warns against use of Reglan

Clinical trials are medical research studies involving people that seek to prevent disease, find treatments, diagnose diseases, or control symptoms. Trials on experimental drugs, such as the GERD study, aim to identify if the drug is safe, has side effects, works better than currently used treatments, and helps users feel better. Experimental drugs are not tested on people unless they show promising results in laboratory tests.

GERD is a chronic condition in which the liquid contents of the stomach regurgitate or back up into the esophagus. This liquid can inflame and irritate the lining of the esophagus, causing symptoms such as heartburn, sour taste in the back of the throat, a dry cough and interrupted sleep. If left untreated, it can also lead to esophageal cancer.

Treatments include diet changes and medication. While many drugs are available over-the-counter to treat heartburn, more potent prescription alternatives are limited. One common prescription treatment is Reglan (metoclopramide), however the drug carries an FDA black box warning of a serious, involuntary movement disorder known as Tardive Dyskinesia. For sufferers of GERD, identifying a safe and effective treatment could be life changing.

SOURCE: Reglan Side Effects › Participants needed for clinical trial on new GERD treatment

Mary suffers from gastroparesis, a condition in which the stomach takes too long to empty its contents. It is a debilitating condition that can strike anyone, but people with diabetes are more susceptible. As many as 50 percent of people with type 2 diabetes and 20 percent with type 1 diabetes have the gastrointestinal disorder.

Treatment for gastroparesis can be discouraging. Some people can manage the condition by limiting their diet. Others must rely on medications, such as Reglan (metoclopramide), which can have serious side effects such as a involuntary movement disorder known as Tardive Dyskinesia.

With little hope left, Mary chose another option – to have an innovative new surgery available at Texas Tech University’s Paul Foster School of Medicine. As part of the surgery, doctors will implant a device called the Enterra into Mary’s abdomen. “It’s a very powerful anti-nausea, anti-vomiting tool,” gastroneurologist Richard McCallum, founding chair at the Paul Foster School of Medicine, told KTSM-TV.

Mary’s surgery will be third of its kind performed at the El Paso medical center. “Even if my symptoms got 50 percent better, it would be a huge change in my day,” Mary said.

SOURCE: Reglan Side Effects › Woman to have innovative new surgery to treat gastroparesis

Most people dismiss the idea that they even have the acid reflux condition because they have none of the classic symptoms, but many sufferers of chronic cough may find relief when treating themselves for GERD.

One man wrote to popular medical question-and-answer columnist Dr. Gott about his dry, hacking cough that seemed to last the entire winter. His allergist gave him a thorough exam and offered numerous suggestions. Then he added, if all else fails, try an over-the-counter heartburn medication. The reader did, and his symptoms subsided.

“My hat is off to your allergist for thinking outside the box of his specialty and doing everything he could to help you,” Dr. Gott replied to the reader.

GERD is a chronic digestive disease that affects millions of Americans. It can be treated with lifestyle changes and over-the-counter treatments such as antacids and medications. However, some may need stronger medications available only by prescription, such as Reglan (metoclopramide). As with many drugs, there are risks to Reglan.

Last year, the Food and Drug Administration (FDA) placed a black box warning on Reglan after numerous reports of patients suffering from an involuntary movement disorder known as Tardive Dyskinesia.

For more information on diagnosing or treating GERD, contact your health care professional.

Sources:
Go Erie
Mayo Clinic

SOURCE: Reglan Side Effects › Chronic cough may be symptom of GERD

Such research could help the approximately 5 million people who suffer from gastric mobility disorders such as gastroparesis and chronic intestinal pseudo-obtruction. People with these conditions “suffer from the debilitating effects of chronic nausea, vomiting, abdominal pain, malnutrition, dehydration, and weight loss. Many cannot eat a bite of food or take a sip of fluid without getting sick. Some patients are disabled and completely homebound, relying on artificial nutrition in order to stay alive,” according to G-PACT.

Treatments for these conditions are mostly limited to medications, like Reglan (metoclopramide), which cannot be used on a long-term basis without putting users at risk for serious side effects.

“Having been a skin cancer
 sufferer, we would expect Mr. McCain to have a better understanding of
 the struggle that chronic disease sufferers have to live a normal life,
 maintaining careers, families and health,” the petition states. “We also implore others in public life to work to help in our fight to 
gain further understanding, awareness and most importantly cures of GI 
motility disease that all too often causes pain and starvation to 
individuals who did not seek such illness and who did not choose this
 fight.”

To join this fight, sign the petition.

Source, About.com

SOURCE: Reglan Side Effects › Gastroparesis group to petition Sen. McCain about criticism of IBS funding

However, it took more than a decade for the Food and Drug Administration (FDA) to place a black box warning on the medication, Reglan. A black box warning is the strongest warning issued by the FDA and is placed on drugs that have potentially harmful or deadly side effects. Meanwhile, the drug was dispensed 6.5 million times in 2008 to an estimated 2 million Americans.

Reglan, also known by the generic brand metoclopramide, is available in formulations including tablets, orally dissolving tablets, syrups and injections. It works by increasing muscle contractions in the upper digestive tract, which speeds up the rate at which the stomach empties into the intestines. But it also can lead to involuntary movements of the muscles, causing users to smack their lips, thrust their tongue, blink and bulge their eyes, jerk their heads, and purse their lips. Tardive Dyskinesia is debilitating and often symptoms don’t subside even after the medication has been discontinued.

So, why would it take the FDA so long to issue a warning about a medication with published reports of serious adverse events? Herb Denenberg with the Philadelphia newspaper The Bulletin, says delayed action by the government agency is not uncommon.

“This delayed warning of a drug’s danger is all too typical. It took (13) years for the FDA to sound this alarm put forth by Worst Pills, Best Pills News in 1996, thus needlessly exposing many millions to a serious side effect that might plague them for life, and might have been avoided if they were properly warned,” Denenberg argues. “I’d add to that warning. First, everyone should understand, as the Physicians’ Desk Reference explains, that side effects from the drug are unpredictable. The medication guide for Reglan states: ‘It is not possible for your doctor to know if you will get TD [Tardive Dyskinesia].’ So even short-term use may cause Tardive Dyskinesia. Second, the patient – not the doctor or the FDA – should decide whether the benefits of the drug are worth the risks of taking it. The patient should ask the doctor if there are other treatments, including other drugs that might be better options, or perhaps non-drug treatments that might be much safer.”

SOURCE: Reglan Side Effects › Why did FDA take so long to place black box warning on Reglan?

Tardive Dyskensia is a condition in which a person develops involuntary movements that can include lip smacking, facial grimacing, tongue thrusting, eye blinking and bulging, head jerking, and involuntary movements of the fingers. It can be debilitating for those who suffer from the condition. Metoclopramide carries the greatest risk when it is taken for 12 weeks or longer. Women and the elderly are at higher risk, and there is known know cure. Even after stopping the medication, the symptoms may persist.

In early 2009, the Food and Drug Administration (FDA) issued a black box warning – the agency’s sternest warning reserved for drugs that carry a risk of serious adverse events – on metoclopramide, urging doctors to avoid long-term use of the drug except in rare cases where the benefits outweigh the risks. That warning came too late for many patients, who are now handicapped because of the medication.

SOURCE: Reglan Side Effects › Black box warning on Reglan came too late for some

Cancer of the esophagus is one of the 10 most common cancers, yet there is no good treatment for the disease. Most people who have been diagnosed with esophageal cancer also have a long history of heartburn. Heartburn occurs when toxic acid from the stomach splashes up into the esophagus. Over time, if left untreated, this constant bathing of stomach acid can damage tissue in the esophagus, a condition known as Barrett’s esophagus.

Barrett’s esophagus is generally treated with the same medications used to treat heartburn and GERD, including Reglan (metoclopramide).

The damaged tissue of Barrett’s esophagus cannot be reserved and if left untreated can lead to esophageal cancer. It is also impossible to remove the damaged tissue, which means the risk of cancer is always a threat.

However, Hans Clevers of the Hubrecht Institute had a hunch. He believed that since the cells in Barrett’s esophagus are very similar to the cells that line the colon, they might share some qualities that could lead to a better understanding in the treatment of Barrett’s esophagus. Researchers determined that the anti-Alzheimer’s drug DBZ, currently in clinical trials, had side effects that affected the lining of the lower colon. Using rat models, Clevers observed the effects of DBZ on Barrett’s esophagus tissue and found that the drug not only halted the growth of Barrett’s esophagus, in some cases it also completely destroyed the mutant tissue.

The treatment is far from human trials, but it still offers hope for a better treatment for Barrett’s esophagus and esophageal cancer in the future.

SOURCE: Reglan Side Effects › Alzheimer’s drug may treat Barrett’s esophagus, esophageal cancer

“This is a significant finding, as it shows that loss of the enzyme that makes carbon monoxide is the actor in this process and that it provides us with a clear approach toward a possible new therapy for this condition,” says Gianrico Farrugia, M.D., Mayo Clinic gastroenterologist and lead investigator on the study, in a Science Daily report.

Gastroparesis is a serious condition that causes pain, nausea, vomiting, stomach spasms, weight loss and nutritional deficiencies. It is usually treated through diet, medication or surgery. Treatments are often unreliable or not recommended for long-term use. Finding a way to reverse the condition would give hope to millions of people who are suffering from the effects of gastroparesis.

As part of the study, researchers studied 10 mice that exhibited delayed gastric emptying. Five were given carbon monoxide by inhalation (100 parts per million) for six hours daily. Within three weeks, gastroparesis was reversed in the mice who received the therapy. While the metabolite that normalizes gastric functioning was not known, using carbon monoxide to treat the mice was a hunch on the part of scientists based on previous studies by the team that showed that gastroparesis is associated with the loss of up-regulation of the heme oxygenase-1 (HO1) and an increase in oxidative stress. In the previous study, the team noted that when they induced HO1 production signs of oxidative stress dropped and gastroparesis was restored.

SOURCE: Reglan Side Effects › Study may lead to new treatment of gastroparesis

The Fifth Circuit upheld a lower court ruling that Actavis Inc., could face claims made by Julie Demahy, of Louisiana, who said the drug maker should have warned her of risks of serious adverse events associated with metoclopramide, a medication used to treat heartburn, GERD and gastroparesis, and known by the brand name Reglan. Demahy claimed she suffered a debilitating movement disorder known as Tardive Dyskinesia after taking metoclopramide, and that the drug company failed to alert her of any risks associated with the medication or to change the drug’s labeling to warn of the risk of developing the disorder.

Last year, the Food and Drug Administration (FDA) ordered a black box warning on metoclopramide prescriptions after reports of Tardive Dyskinesia were associated with use of the medication. Long-term use of 12 weeks or more increased one’s risk of developing the disorder to 20 percent or more.

SOURCE: Reglan Side Effects › Ruling: patients may sue generic drug makers under state law

Some studies show that patients who take the medications for more than 12 weeks, as well as the elderly, are as much as 20 to 70 percent at risk for developing Tardive Dyskinesia. Medications like Reglan (metoclopramide) may mask the symptoms, which can become more prevalent after the medication is discontinued. Even after patients stop taking the drugs, symptoms may persist.

Symptoms include involuntary lip smacking, blinking, raising eyebrows, tongue twitching and protrusion, toe tapping, and jerking, repetitive, involuntary motions of the fingers, hands, arms, legs and/or torso. For some, the movements are slight and hardly noticeable. For others, the involuntary movements are severe and debilitating.

Unfortunately, there is no way to predict who will suffer the symptoms of Tardive Dyskinesia, which makes it even more important that patients understand the risks of their medication. Recently, the Food and Drug Administration (FDA) issued a black box warning, its most serious warning, on Reglan (metoclopramide) because of the risk of Tardive Dyskinesia especially with long-term use of the medication. An estimated two million people take some form of Reglan (metoclopramide), and may be at risk for developing the movement disorder.

SOURCE: Reglan Side Effects › Movement disorder linked to common medications

GERD is chronic heartburn, a condition caused when food or liquid travels backwards from the stomach to the esophagus causing a burning sensation in the throat or chest. It can be bothersome to adults, and cause problems for infants, making them irritable and unwilling to eat.

As many as 70 percent of all babies spit up on occasion, which is normal and doesn’t require treatment. The number of infants who actually suffer from GERD is thought to be as low as five percent. Yet, diagnosing irritable babies with GERD seems to be the trend, says Dr. Eric Hassal, a gastroenterologist at the B.C. Children’s Hospital in Vancouver. And that can lead to over-prescribing of medication that some argue has not been sufficiently studied, especially in pediatric patients.

“Now everybody’s saying, ‘Oh, they must have reflux because they are spitting up. And we’ve got these great brand new drugs that we should give your baby’,” Dr. Hassall told CTV News.

While medication is a viable treatment for people who suffer from heartburn and GERD symptoms, like all medications, they should be taken with caution. For example, one common GERD medication prescribed for both adult and pediatric patients, Reglan (metoclopramide), recently received a black box warning by the FDA after numerous patients who took the drug reported suffering from a serious debilitating movement disorder known as Tardive Dyskinesia.

That is one reason why Dr. Hassal recommends parents first take a non-medicinal approach to treating their babies who appear to be suffering from symptoms of GERD, which includes keeping the baby in an upright position for as long as possible after meals, avoiding tobacco smoke, swaddling the baby, and carrying the baby in a carrier close to your body. Diet changes and better burping practices can also help improve symptoms.

SOURCE: Reglan Side Effects › GERD a trendy diagnosis for fussy infants

Generic drug makers successfully argued in district court that a Food and Drug Administration  (FDA) regulation that required generic drugs to carry the same labels as their brand-name equivalents conflicted with the failure-to-warn claims. However, the Eighth Circuit Court overturned the dismissal resulting in a victory for Mensing.

It proved too late for Mensing, but earlier this year the FDA issued a black box warning for Reglan (metoclopramide), advising physicians to avoid long-term use of the drug except in rare cases where the benefit outweighs the risks. Long-term users and elderly patients, especially women, are at an increased risk for developing the serious movement disorder. There is no known cure for Tardive Dyskinesia, even after the medication has been discontinued.

Patients currently taking Reglan or the generic metoclopramide should discuss any risks or side effects with their health care provider.

SOURCE: Reglan Side Effects › Makers of generic Reglan liable for inadequate warning labels

Click here to view the embedded video.

People of all ages, shapes and sizes suffer from gastroparesis. The National Institutes of Health estimates as many as 10 million people are living with gastroparesis. Because of the lack of medical education and improper diagnosis, many more may be suffering in silence. Symptoms include abdominal cramps, nausea and vomiting and can result in dehydration, electrolyte imbalances and malnutrition.

Treatments include medication, such as Reglan (metoclopramide), and surgery. Those with gastroparesis suffered yet another blow this year when the Food and Drug Administration (FDA) issued a black box warning on Reglan after numerous cases of a serious movement disorder known as Tardive Dyskinesia were reported in patients who took Reglan. Long-term users were as much as 20 percent at risk of developing the condition.

Because treatments offer only temporary benefits to patients, activists groups such as the Gastroparesis Awareness Campaign Organization are working to raise awareness in hopes of finding better, safer treatments and, eventually, a cure.

SOURCE: Reglan Side Effects › Gastroparesis organization raises awareness through video

One popular choice in acid reflux treatment are pills known as Proton-Pump Inhibitors. “The dark side of Proton-Pump Inhibitors, because we’ve used so much of them for such a long period of time, is beginning to emerge,” says Dr. Henri Roca of LSU Health Sciences Center’s Family and Integrative Medicine during a interview with WWL-TV in New Orleans.

Proton-Pump Inhibitors are available both by prescription, such as Nexium, and over-the-counter, as Prevacid, Omeprazole and Prilosec. These drugs are recommended for use for seven or eight weeks. When someone takes them for 12 weeks or longer, problems arise.

When taken long term, Proton-Pump Inhibitors can inhibit the body from properly absorbing calcium, which puts long-term users at high risk for osteoporosis. It also interferes with the body’s defense mechanisms by clearing up bacteria that benefits the stomach and intestines, thus contributing to more gastrointestinal infections. And recently, the Food and Drug Administration (FDA) issued a warning about the combined use of the heart medication Plavix with Proton-Pump Inhibitors after tests showed that the Proton-Pump Inhibitors reduced the effectiveness of Plavix.

Another type of medication used to treat heartburn symptoms available only by prescription is Reglan (metoclopramide). Again, long-term (12 weeks or more) use of Reglan can have serious consequences. Early this year the FDA issued a black box warning on Reglan and other metoclopramide medications after numerous cases of a serious movement disorder known as Tardive Dyskinesia had been linked to use of Reglan. Tardive Dyskinesia can be debilitating and the symptoms may not stop even after the medication has been discontinued.

Doctors advise patients to talk with the doctors about their symptoms and any medications they may be taking. According to Dr. Roca, your symptoms may be caused by a number of ailments, and there may be safer and more effective ways to treat your heartburn symptoms.

SOURCE: Reglan Side Effects › Long term use of heartburn drugs can be dangerous

Another chronic sneezer, 22-year-old Caileen Wendel of Pennsylvania, says she sympathizes with Johnson because she has suffered from the same sneezing symptoms for five years. Doctors were also baffled by her condition and after 40 emergency room visits, Wendel finally found a doctor willing to try something new. Dr. Larry Geisler with St. Mary’s Hospital in Langhorne, Pa., prescribed the anti-nausea drug Reglan (metoclopramide) with Benedryl. Within five minutes, Wendel’s sneezing stopped.

“I don’t know if it’s a fix-all, but it happened to work and it worked for Caileen,” Dr. Geisler told NBC Philadelphia. It is a blessing that Wendel’s treatment is working, giving her life back. “To be able to stop something that I have no control over is probably one of the best feelings in the world,” she said. Both Wendel and Dr. Geisler hope that the same combination of medications can help Johnson.

Wendel says her symptoms return from time to time, and when they do she gets back on the combined Reglan-with-Benedryl meds and the sneezing stops. But, staying on the drug long term is not an option for Wendel. While Benedryl is available over-the-counter, Reglan requires a prescription, and carries a black box warning, issued earlier this year by the Food and Drug Administration (FDA). The warning was issued after the FDA received numerous reports of a serious movement disorder known as Tardive Dyskinesia in people who had taken Reglan. Studies have shown that people who take the drug for more than 12 weeks are as much as 20 percent at risk for developing the condition.

SOURCE: Reglan Side Effects › Reglan may calm chronic sneezing fits, but long-term use risky

In a Phase IIb trial, Addex’s ADX10059 increased performed well in the treatment of gastroesophageal reflux disease (GERD). The four-week trial, which comprised 103 patients, showed ADX10059 significantly increased the number of symptom-free days for patients that took the drug compared to patients on a placebo. Patients involved in the trial had previously responded well to a group of drugs widely used for combating acid reflux called proton pump inhibitors, (PPIs).

The trial also showed that the medication was well tolerated among those in the trial. While adverse events were reported more often among those taking ADX10059 than the placebo group, the company reports that the vast majority of events were mild and none were described as severe. Participants who took ADX10059 also indicated a reduction in sleep disturbance compared to those in the placebo group, according to a patient questionnaire.

Addex says it has also completed patient recruitment for another trial of ADX10059, which combines the medication with PPIs. Results on that trial are expected in January 2010.

The results set Addex up to license the drug to a larger pharmaceutical company, which is anticipated sometime in 2010. Some estimates say a partnership could generate as much as $1.25 billion in annual sales.

Source: Addex Pharmaceuticals

SOURCE: Reglan Side Effects › New heartburn medication meets expectations in drug trial

Side effects of nizatidine include abdominal pain, diarrhea, dizziness, gas, headache, indigestion, inflammation of the nose, nausea, pain, sore throat, vomiting and weakness.

The new generic medication offers another drug choice for patients who suffer from uncomfortable and sometimes painful symptoms of GERD. Another popular prescription drug in the treatment of GERD includes Reglan (metoclopramide). Earlier this year the FDA issued a black box warning on metoclopramide products following reports of an involuntary movement disorder known as Tardive Dyskinesia in patients who took metoclopramide for more than 12 weeks.

People who suffer from Tardive Dyskinesia experience involuntary movements of their muscles which can include lip smacking, tongue thrusting, eye blinking and bulging, head jerking, facial grimacing, puckering and pursing of the lips, and involuntary movements of the fingers.

This fall, the FDA approved an orally dissolving tablet form of metoclopramide under the brand name Metozolv ODT. That medication also falls under the same black box warning as other metoclopramide products, such as Reglan. Nizatidine is not the same medication as metoclopramide, and thus does not fall under the same FDA warning.

Source: FDA

SOURCE: Reglan Side Effects › FDA approves generic GERD treatment

GERD is a condition thought to be the result of an acid burn caused by stomach acid splashing up into the esophagus. It is often treated with medications that reduce stomach acid, such as Reglan (metoclopramide). But the new study squashes the “acid burn” belief. “Chemical injuries develop immediately,” the study’s leader, Dr. Stuart Spechler, told Reuters. “If you spill battery acid on your hand, you don’t have to wait a month to see the damage.”

Researchers say that the findings from the new study could change the way GERD is treated. “Currently, we treat GERD by giving medications to prevent the stomach from making acid,” said Dr. Rhonda Souza. “But if GERD is really an immune-mediated injury, maybe we should create medications that would prevent these cytokines from attracting inflammatory cells to the esophagus and starting the injury in the first place.”

An estimated 40 percent of Americans experience symptoms of GERD at some point, and as many as 20 percent suffer from persistent symptoms. If left untreated, GERD can cause esophageal cancer.

SOURCE: Reglan Side Effects › New study may lead to different treatments for GERD

Hiccups are usually a short-lived condition, with bouts lasting no longer than 30 hiccups. While the cause is relatively unknown, some things can trigger an episode of the hiccups, such as an overly full stomach (from too much food, alcohol or air), sudden temperature changes, smoking cigarettes, excitement or stress, and some medications. But for some, hiccups can last hours or even days. One man in Iowa reportedly had hiccups that lasted 60 years. Constant hiccups can make eating, drinking and sleeping difficult, and may require medical treatment to get under control.

If you suffer from hiccups that last an unusually long time, seek medical attention. Your doctor may first want to rule out any underlying medical conditions. While unlikely the case, constant hiccups may be a symptom of a more serious problem, such as laryngitis, gloiters, tumors in the neck, infections near the diaphragm, hiatus hernia, kidney failure, ear infection, aortic aneurysms and multiple sclerosis.

While rarely performed, hiccups can be treated with surgery. One type of surgery involves a nerve block that stops the major nerve supply for the diaphragm from sending signals to the diaphragm. The other involves implanting a pacemaker into the diaphragm to control contractions in the diaphragm. Most doctors, however, will choose a less invasive route, which may include medications.

Drugs that have been shown to reduce hiccups are the antipsychotic chlorpromazine, antispastic medication baclofen and metoclopramide. While medications may offer relief, patients should be aware of any serious side effects. For example, metoclopramide carries an FDA black box warning about the risk of a serious movement disorder known as Tardive Dyskinesia.

If your hiccups are persistent, don’t sit back and suffer. Consult with your doctor about the right treatment for you.

Source: MSN Health

SOURCE: Reglan Side Effects › Reglan may stop hiccups, but may cause more serious problems

Dr. David Carroll of Surgical Specialists of Jackson, Miss., offers a completely noninvasive procedure to treat GERD that requires no injection, cutting or penetration of the skin. It is called transoral incisionless fundoplication (TIF) surgery with the EsophyX device. Dr. Carroll says he has performed the procedure many times laparoscopically over the past 15 years, but the new EsophyX device allows him to perform the surgery using an endoscope inserted through the patients’ mouths.

“It developed over the last several years. The results are really good,” Dr. Carroll told the Clarion Ledger. He performed the first TIF with the EsophyX in Mississippi on 46-year-old Connie Braswell of Pearl, Miss. Braswell had treated her GERD symptoms for years with Nexium, but last year her symptoms worsened. “It got to the point where I was burping every day, all day long. It was very irritating,” she says.

Two gasterenterologists and two general practitioners tried her on various medications, including Reglan (metoclopramide), but nothing worked. She began restricting her diet, giving up dairy products, spicy food, coffee, and her beloved Dr. Pepper. She shed 28 pounds in the process, but she wasn’t happy. She missed the foods she used to enjoy.

Then Dr. Carroll told her about the new, noninvasive procedure using the EsophyX device, and it changed her life. “I prayed and prayed to get better and nothing else worked,” she says. “and this is working.”

Pictured are Dr. David Carroll, Dr. Jeffrey Glover and Dr. David Miller of Surgical Specialists of Jackson.

SOURCE: Reglan Side Effects › Non-surgical procedure offers hope to patients with GERD

Gastroparesis is a serious condition in which food takes too long to move through the stomach. It can result in pain and disability as well as poor nutrition. Those who suffer are usually treated with medication. But sometimes the medication does not work or can cause serious side effects.

One such treatment is metoclopramide, known in the U.S. by the brand name Reglan. While it can provide relief to some patients, long-term use of metoclopramide has been linked to a serious movement disorder known as Tardive Dyskinesia. Those who suffer from the condition have involuntary movements of their muscles which can include lip smacking, tongue thrusting, eye blinking and bulging, head jerking, facial grimacing, puckering and pursing of the lips, and involuntary movements of the fingers.

Medication wasn’t working for Munshi, but she found relief through the Internet in another from, a gastric pacemaker that is implanted in the stomach that shocks the stomach muscles to contract. After surgery, Munshi says doctors gave her tomato soup, but the patient felt so much better that when she got home she devoured her favorite dish – saag aloo. “Everything tastes great now and I haven’t been sick since,” she says.

Sources:
The Metro
The Sun

SOURCE: Reglan Side Effects › Pacemaker gives hope to sufferer of gastroparesis

Patients who suffer from regular vomiting, stomach pain or trouble swallowing are usually given diagnostic tests such as endoscopies, biopsies and CT scans. Some patients are sent to other cities for more advanced testing. With the opening of El Paso’s new clinic, patients who suffer from serious gastrointestinal conditions have more options for specialized care.

“Rather than sending patients to the Mayo Clinic, we can take care of them right here,” says Dr. Richard McCallum, a gastroenterologist and chairman of the Department of Internal Medicine at El Paso’s medical school, in an interview with the El Paso Times. “We offer a very cutting-edge array of the best tests to diagnose the disorders.”

These tests include an esophageal motility test to measure the muscles and pressure of the esophagus; and a gastric emptying test and an ingestible SmartPill, both of which monitor how quickly food leaves the stomach. “These are a series of tests the average hospital and (doctor’s) office do not have,” Dr. McCallum says.

The center will also conduct medical students for new drugs and treatments for various gastrointestinal conditions, including gastroparesis, a condition in which the stomach empties its contents too slowly causing pain, disability and nutritional problems for those who suffer from the condition.

SOURCE: Reglan Side Effects › New medical center to focus on gastrointestinal disorders

Marketing for Metozolv was approved last September by the Food and Drug Administration (FDA) for the treatment of short-term therapy (4-12 weeks) for adults with symptomatic documented gastroesophageal reflux disease (GERD) who fail to respond to conventional therapy. It also is the first orally disintegrating tablet formulation for both acute and recurrent diabetic gastroparesis.

“We are very proud to achieve the FDA approval of Metozolv ODT,” said Eugene T. Haley, CEO of Wilmington Pharmaceuticals, developers of Metozolv. “We’re especially pleased that the application of Catalent’s Zydis technology to this proven medication may enhance the lives of patients for years to come. Metozolv’s success further validates the commercial attractiveness of fast-dissolving dosage forms and illustrates the significant inherent value in bringing together a game-changing drug delivery technology with product development expertise and a top notch sales and marketing organization.”

While approved by the FDA, Metozolv carries the same black box warning as other metoclopramide products, such as Reglan. The medication fell under the warning earlier this year after numerous reports of a serious movement disorder known as Tardive Dyskinesia were linked to long-term use of metoclopramide.

Source: Reuters

SOURCE: Reglan Side Effects › New GERD, gastroparesis treatment uses fast-dissolve technology

Dystonia is a neurological movement disorder that can be disabling. Those who suffer from the condition experience muscle contractions that cause twisting and repetitive movements or abnormal postures. The causes are not completely known or understood, but it is believed to be either inherited or caused by factors such as birth-related or physical trauma, infection, poisoning (such as lead poisoning), or reaction to drugs (such as Reglan, also known as metoclopramide, a common medication to treat heartburn, GERD and gastroparesis). For one athletic young woman, the cause was likely due to a seasonal flu shot.

25-year-old Desiree Jennings, who was training to be a professional football cheerleader, got a flu shot in August. Ten days later she began suffering from dystonia. Now she cannot walk or talk without difficulty. Oddly, she can run seemingly normally. While running she can talk normally, too. She can even walk backwards without the excessive movements. But when she stops or begins to move forward, the jerking movements come back.

Reactions to the flu shot like Jennings’ is rare, but the risk of developing a type of dystonia is greater with some medications. For example, the Food and Drug Administration earlier this year issued a black box warning on Reglan after reports of patients who took the medication began suffering from a type of dystonia known as Tardive Dyskinesia. Up to 20 percent of consumers who took Reglan for more than 12 weeks contracted the disorder. Now the drug’s label warns users against long-term use, but the warnings come too late for too many who are suffering just like Jennings.

SOURCE: Reglan Side Effects › Woman suffers from movement disorder after getting flu shot

More and more cases of consumers taking metoclopramide and subsequently developing Tardive Dyskinesia were reported to the Food and Drug Administration (FDA), and by early 2009, the agency had ordered a black box warning be placed on the medication. New warnings and precautions were written into the drug’s packaging that included an up to 20 percent risk of patients developing Tardive Dyskinesia during long-term use of the medication.

But the warnings came too late for Conte, and for her doctor, who she alleges was unaware of the risks because Reglan’s maker, Wyeth, disseminated misleading and/or incomplete warnings about the drug’s side effects. She sued Wyeth, claiming the company knew of a widespread tendency among physicians to mis-prescribe Reglan and generic metoclopramide for long periods of time even though the medication is only approved for 12 months of use. The drug’s labeling, her lawsuit claimed, substantially understated the risks of serious side effects from extended use.

Initially, the trial court ruled in favor of Wyeth, which argued that it was the physician’s duty to warn patients of any ill effects drugs may have on patients. Conte appealed, arguing the drug’s manufacturer should be responsible. The Court of Appeal concluded that Wyeth was obligated to disseminate accurate product warning labels.

Source: Sierra Sun

SOURCE: Reglan Side Effects › Women suffering from movement disorder sues Reglan maker Wyeth

The study, conducted by researchers from Copenhagen University, involved 120 healthy participants who took either an inactive placebo or 40 mg of the PPI drugs daily for three months. Each patient filled out a Gastrointestinal Symptom Rating Scale weekly to gauge symptoms. Researchers found that a greater percentage of people taking the PPI experienced at least one worrisome acid-related symptom during the treatment than those taking a placebo.

“We find it highly likely that the symptoms observed in this trial are caused by rebound acid hypersecretion and that this phenomenon is equally relevant in patients treated long term with PPIs. If rebound acid hypersecretion induces acid-related symptoms, this might lead to PPI dependency. Our results justify the speculation that PPI dependency could be one of the explanations for the rapidly and continuously increasing use of PPIs,” said Dr. Christian Reimer, the study’s lead author.

These findings show that safe treatment options for people suffering from GERD are limited. Earlier this year, Reglan (metoclopramide), another treatment for the condition, received a black box warning from the Food and Drug Administration (FDA) after numerous reports that people taking Reglan began to suffer suffer from a serious, involuntary movement disorder known as Tardive Dyskinesia. The black box warning advises that the medication not be taken for more than 12 weeks as the risk of contracting the disorder increases to about 20 percent among those taking the drug long term.

Experts advise suffers of GERD should consult with their physicians to find the safest treatment options.

SOURCE: Reglan Side Effects › Heartburn, GERD treatments linked to serious complications

According to researchers at the Feinstein Institute, there are two separate pathways in the brain that influence the severity of the symptoms of movement disorders. All individuals who carry the mutations and symptoms for dystonia have an abnormal pathway between the cerebellum and the thalamus. These patients also have a normal second pathway between the thalamus and the cortex. However, researchers found that patients who have the mutation in the first pathway as well as in the second pathway have no symptoms of dystonia. In effect, the two defects seem to cancel each other out.

Researchers say this could be promising news to individuals who suffer from various movement disorders, from Parkinson’s disease to Tardive Dyskinesia, a condition that results from long term use of medications such as metoclopramide, a treatment for GERD and gastroparesis, and antidepressants.

One surgical treatment for both that has shown promising improvements in motor symptoms is known as deep brain stimulation, or DBS. Which leads researchers to ask, does abnormal brain wiring improve dystonia the same way as DBS?

Source: Brain Blogger

SOURCE: Reglan Side Effects › Brain mutation may prevent movement disorders

Last month, the FDA issued a black box warning on the injectable form of promethazine hydrochloride. Promethazine hydrochloride, once sold under the now-discontinued brand name Phenergan, is available in generic formulations in the form of tablets, liquid, rectal suppository, intravenous injection and intramuscular injection. The black box warning cautions health care providers against administering the IV injection into an artery or under the skin because gangrene or other severe tissue injury can result. It also can leach out from the vein during IV administration, causing serious tissue damage.

Another anti-nausea medication is metoclopramide, known by the brand names Reglan and Metozolov. The drug can be administered by injection, or taken as a pill by mouth. Metoclopramide is also a treatment for gastrointestinal conditions such as gastroparesis and GERD. Earlier this year, an FDA black box warning was placed on metoclopramide after long-term use of the drug was linked to a serious and debilitating involuntary movement disorder known as Tardive Dyskinesia.

Tardive Dyskinesia is identified by involuntary head jerking, eye blinking, facial grimacing, pucker and pursing of the lips, lip smacking and tongue thrusting. It may also involve involuntary movements of the fingers and hands. There is no known cure for Tardive Dyskinesia, even after the medication has been discontinued.

SOURCE: Reglan Side Effects › Anti-nausea drugs carry black box warnings

This is promising news, considering there are no FDA-approved drugs to treat morning sickness, and drugs once thought safe for unborn babies, such as Thalidomide and Bendectin, were later linked to serious birth defects such as limb deformities.

Critics argue that there is not enough good-quality evidence that metoclopramide is safe for pregnant women or that it is effective in curtailing nausea and vomiting. One study of 40 women found that steroids worked better than metoclopramide for women, resulting in fewer times a woman vomited and eliminating the need for hospitalization.

Another concern about metoclopramide is the black box warning that is now on the drugs. The new labeling warns patients treated with metoclopramide of the risk of developing a serious and debilitating involuntary movement disorder known as Tardive Dyskinesia. The symptoms, which include jerking, facial twitches and involuntary movements of the hands and tongue, often do not go away after treatment is discontinued.

The risk of Tardive Dyskinesia is even greater for patients who take the metoclopramide for 12 weeks or longer, with some studies showing as many as 20 percent of long-term users developing the condition.

Serious morning sickness can cause problems for both the mother and her unborn child, which is why women who suffer from morning sickness should thoroughly discuss their treatment options with their physician to better understand the benefits and risks.

SOURCE: Reglan Side Effects › Pregnant women should weigh risks of morning sickness medications

Medications most often associated with Tardive Dyskinesia include metoclopramide, known in the U.S. by the brand names Reglan and Metozolv, and psychiatric drugs Thorazine, Stelazine, Haldol, Prolixin, Zyprexa, Risperdal and Clozaril.

While nothing seems to cure the condition, some treatments have been shown to bring relief to sufferers. Those treatments include:

- Vitamin E may have some beneficial effects on patients, especially those who have not yet developed Tardive Dyskinesia. Since large doses of vitamin E can be toxic, it is recommended that patients consult with their doctors before adding supplemental vitamin E to their diets.
- Botulinum toxin injections (BTX), also known as BOTOX therapy, has been shown to relieve symptoms that involved limited groups of muscles. Consult with your doctor to see if this form of treatment is right for you.
- Some medications have been used to successfully treat Tardive Dyskinesia. Talk with your doctor about options in drug therapy.

If you suffer from Tardive Dyskinesia, or are experiencing any unusual and involuntary movements, and take or have taken metoclopramide or any psychiatric drugs, you are encouraged to seek specialized medical treatment.

Source: National Empowerment Center

SOURCE: Reglan Side Effects › Treatments available for drug-induced Tardive Dyskinesia

Tardive Dyskinesia and Tardive Dystonia are serious movement disorders caused by psychiatric medications. Earlier this year, the Food and Drug Administration (FDA) issued a black box warning to patients and health care providers that patients taking metoclopramide, a drug to treat heartburn, GERD and other gastrointestinal conditions, were at greater risk of developing Tardive Dyskinesia. Patients who used metoclopramide for 12 weeks or longer were at an even greater risk of developing the condition. Some studies show as many as 20 percent of patients who used metoclopramide long-term developed the disorder.

Metoclopramide is known in the U.S. by the brand name Reglan. A orally dissolving table form of metoclopramide, Metozolv, has just been approved by the FDA and carries the same black box warning for Tardive Dyskinesia.

Tardive Dyskinesia expresses itself in various ways, including involuntary lip smacking; blinking; raising eyebrows; tongue twitching and protrusion; toe tapping; and jerking; and repetitive, involuntary motions of the fingers, hands, arms, legs and/or torso. Sometimes movements are slight and barley noticeable. For others, the movements are debilitating and sometimes painful. The movements usually cease during sleep but are more pronounced when the sufferer is anxious or under stress.

There have been successful lawsuits filed by individuals diagnosed with Tardive Dyskinesia that has been caused by their medication, including one in which a jury awarded the plaintiff $1.3 million. If you have suffered from involuntary movements following use of metoclopramide or any other medication, you may have a claim against the drug maker.

SOURCE: Reglan Side Effects › Few resources available for those with Tardive Dyskinesia

Metoclopramide is most commonly known in the U.S. by the brand name Reglan, made by Schwarz Pharma. Salix Pharmaceuticals also just received FDA approval to market in the U.S. an orally disintegrating metoclopramide tablet by the name of Metozolv. Metoclopramide is also sold in other countries under the brands Maxolon, by Shire/Valeant, Degan by Lek, Maxeran and Primperan by Sanofi Aventis, and Pylomid by Bosnalijek.

The medication is primarily used to facilitate gastric emptying in patients with gastroparesis, and in the treatment of severe GERD. It also is used to treat nausea and vomiting, morning sickness, migraine headaches, and has been shown to stimulate lactation in nursing women.

Because metoclopramide is a dopamine antagonist, it may worsen the symptoms of Parkinson’s disease. It is also contraindicated for patients with a suspected bowel obstruction and those who suffer from clinical depression, as it may aggravate symptoms of depression. But long-term use, which is necessary in some patients, especially those suffering from gastroparesis, has been shown to cause the Parkinson’s-like symptoms of Tardive Dyskinesia among otherwise healthy people. Because of the new black box warning issued by the FDA, labeling for metoclopramide medications now carry a warning of Tardive Dyskinesia. Unfortunately, the warning is too late for many who know find themselves with a diminished quality of life from a medication that was to designed to improve their quality of life.

SOURCE: Reglan Side Effects › Metoclopramide can diminish quality of life

The LINX is a device made up of a string of tiny magnetic beads encased in titanium. During laparoscopic surgery, the beads are placed on the lower end of the esophagus, forming a ring around the lower esophageal sphincter (LES). The force of the magnets pulls each bead closer to those on each side, like a rubber band, preventing stomach acid from refluxing into the esophagus, causing heartburn. Ideally, patients able to stop medications and eat a normal diet by the time they are released from the hospital on the day after surgery.

However, the procedure is not without risks. The beads can migrate from their intended location and need to be removed or replaced. And if the string of beads is not wrapped tightly enough or is wrapped too tightly, it may not work properly. But if it does work effectively, it will offer an alternative to medication for suffers of GERD. Medication that in some cases can cause serious problems for the users.

One of the most common prescriptions for patients with GERD is metoclopramide, known by the brand name Reglan. Earlier this year the Food and Drug Administration (FDA) issued a black box warning on metoclopramide after numerous reports of a serious movement disordered called Tardive Dyskinesia was linked to the use of the drug, in particular the long-term use of metoclopramide. The condition is debilitating and can continue even after the medication has been stopped. Because long-term use of Reglan is now discouraged, patients are hopeful that new treatments will make GERD more manageable.

SOURCE: Reglan Side Effects › New GERD treatment may spell relief for sufferers

What Brittney wants people to understand is what being sick with a chronic illness means. Sure, the condition has left her with a slim figure which has earned her compliments in this society where “skinny” is “in.” But she is far from lucky, she says. “It drives me insane.”

It is unlikely her condition will improve. And people who suffer from gastroparesis have few treatment options. Some people can manage their condition with diet. Others must rely on medication or surgery. But there are risks to surgery, and even the medication raises concerns.

One popular medication for gastroparesis is metoclopramide, known by the brand name Reglan. Earlier this year the Food and Drug Administration (FDA) issued a black box warning on the drug after it was linked to a serious movement disorder known as Tardive Dyskinesia. The debilitating condition often doesn’t go away even after treatment has stopped.

There are several other illnesses besides gastroparesis that fall under the “invisible illness” umbrella, such as Fibromyalgia and scleroderma. For Brittney, raising awareness for such conditions brings her hope that better treatments will be found and she will be able to lead a more normal life. For activities and forums as part of Invisible Illness Week, go to InvisibleIllnessWeek.com.

Source: Journal Star

SOURCE: Reglan Side Effects › Sufferers of chronic conditions raise awareness for invisible Illness week

GERD “disrupts sleep, causes insomnia, and is associated with daytime impairment,” says Dr. Susan M. Harding with the University of Alabama at Birmingham, and may lead sufferers to seek treatment for sleep issues rather than for the condition that is causing the sleep disturbance.

The problem, says Dr. Anthony J. DiMario Jr., who leads a research study on the subject at Thomas Jefferson University, widely prescribed Ambien (zolpidem), which works to suppress nocturnal arousals to aide in restorative sleep, also helps people sleep through their symptoms of GERD. Those who sleep through their symptoms may forgo treatment to stop the symptoms and thus may suffer even worse complications.

GERD can be treated through lifestyle changes, such as raising the head of the bed so that the sufferer doesn’t sleep flat, eating smaller meals, and avoiding foods that promote reflux, such as chocolate, peppermint, alcohol and caffeinated drinks. Some medications, both prescription and OTC, are used to treat the condition, but some carry risks.

Reglan (metoclopramide) is a prescription medication approved in the treatment of GERD. A pro-motility drug that works by stimulating the muscles of the gastrointestingal tract including the esophagus, stomach, small intestines and colon, metoclopramide has been associated with a serious movement disorder known as Tardive Dyskinesia. The condition is debilitating and can continue even after treatment has been stopped.

Sources:
Science Daily
Reuters Health Stories

SOURCE: Reglan Side Effects › Sleep aids may hinder detection of nighttime GERD

The Gastroparesis, etc… blogger was diagnosed with the condition in 2004, and in that time has gathered a great deal of information on treatments for the debilitating condition, which she readily shares on her Web site. Gastroparesis is individualized and a treatment that works for one person may not work for another, she says.

She has tried a long list of treatments from Botox to acupuncture to Reglan, but few have worked well for her. She will receive a gastric neurostimulator, also known as a gastric pacemaker, next week. “It took four months to get the procedure approved by my insurance company, but in that time I gained a great deal of knowledge and collected a plethora of resources which I am anxious to pass along.”

The blogger also passes on to her readers information about new treatments and drug warnings, such as the recent black box warning on metoclopramide, also known by the brand name Reglan, and the newly approved Metozolv ODT, an orally disintegrating version of the same medicine. The black box warning notifies patients and health care workers of an increased risk of a serious movement disorder known as Tardive Dyskinesia associated with long term use of metoclopramide.

Whatever course of treatment sufferers of gastroparesis choose, the blogger offers this advice: “Be your own advocate. Truly, in every way. Do your own research. Try everything for yourself. And never, ever give up!”

SOURCE: Reglan Side Effects › Gastroparesis sufferer urges, Never give up!

Gastroparesis is unpredictable – there are good days and bad, making it hard to manage. There is often no explanation for a drastic change in symptoms from one moment to the next. Because sufferers often do not look sick, gastroparesis, called a “silent illness,” is often disregarded by those who don’t understand it.

G-PACT, www.g-pact.org, is an organization that was founded in 2001 to help increase awareness of gastroparesis and another serious gastrointestinal motility disorder, chronic intestinal pseudo-obstruction (CIP), in an effort to seek funding for better research into the causes of and treatment for the disorder. The site also gives sufferers a community where they can share personal stories and triumphs.

G-PACT aims to help find more options for suffers of serious GI motility disorders. “These conditions are not just inconveniences. They are disabling, and in some instances, can even be fatal,” according to the Web site. “There are few treatment options available, and even those have complications and limited effectiveness. Little attention has been given to these illnesses for research due to lack of awareness of the need.”

One of the few treatments available for gastroparesis is metoclopramide, sold in the U.S. under the brand name Reglan. Earlier this year, the Food and Drug Administration (FDA) issued a black box warning on the drug after numerous reports of a serious movement disorder known as Tardive Dyskinesia were associated with the long term use of Reglan.

According to the organization’s Web site, “GI motility disorders are under-recognized, so therefore ignored by many medical companies, pharmaceutical companies, and the FDA.”

SOURCE: Reglan Side Effects › Organization raises awareness, funding for GI motility disorders

Reglan was first approved by the Food and Drug Administration in 1980 to treat GERD and gastroparesis, or delayed stomach emptying. According to The People’s Pharmacy, “Although doctors were warned early on that this drug could cause a neurological disorder, it took the Food and Drug Administration almost 40 years to issue a black box warning about this complication.”

That warning of an increased risk of Tardive Dyskinesia with long-term use of Reglan was issued on February 26, 2009, and the makers of Reglan were ordered to add it to the medication’s labeling. The condition is characterized by involuntary repetitive movements of the extremities, lip smacking, grimacing, tongue protrusion, rapid eye movements or blinking, puckering and pursing of the lips, or impaired movement of the fingers. Even after medication has been discontinued, symptoms may still persist.

More than 2 million Americans use some form of Reglan, and as many as 20 percent suffer from Tardive Dyskinesia. If you or a loved one have suffered from side effects of Reglan, you may have a claim against the manufacturer.

* names have been changed.

SOURCE: Reglan Side Effects › Long term use of Reglan linked to serious movement disorder

Salix Pharmaceuticals, Ltd

Gastroparesis, or delayed emptying of the stomach contents, affects nearly 1.5 million people and can cause pain, bloating, vomiting and malnutrition. GERD, or gastroesophageal reflux disease, affects approximately one-third of the U.S. population. Metozolv ODT is designed for sufferers of both conditions who have difficulty swallowing, need treatment but do not have water available, or need a portable way to take medication. Metozolv ODT rapidly melts on the tongue and gives patients an alternative to the pill form of metoclopramide.

Metozolv ODT will carry the same black box warning as the brand name metoclopramide, Reglan, which warns users that long-term therapy (12 weeks or longer) increases one’s risk of a serious involuntary movement disorder known as Tardive Dyskinesia. The condition is disabling and does not usually go away once treatment with metoclopramide has stopped.

Metozolov ODT packaging will also warns users that the drug should be used with caution in patients showing acute dystonic reactions, drug-induced Parkinsonism, or other extrapyramidal symptoms, and neuroleptic malignant syndrome with a prior history of depression.

Last week, in anticipation of the FDA’s approval, Salix announced that it will increase its sales force by 60 percent to help market Metozolov ODT. The drug has patent protection until 2017, and additional patent protection pending that, if issued, could provide patent protection until 2025.

Source: Reuters

SOURCE: Reglan Side Effects › Salix receives FDA approval to market new metoclopramide drug

Salix Pharmaceuticals

Salix hopes to gain full FDA approval to market Metozolv as a short-term therapy (4-12 weeks) for adults with symptomatic, documented gastroesophageal reflux (GERD or heartburn) who fail to respond to conventional therapy, and for the relief of symptoms associated with acute and recurrent diabetic gastroparesis, or delayed emptying of the stomach. Salix currently has 96 salespeople and wants to hire and additional 64 people to its sales force this year to help push the new product.

Drugs for such gastrointestinal ailments as gastroparesis are few and far between and not without their issues. It remains to be seen if when Metozolv hits the market, it will carry the same black box warning already on Reglan, an oral tablet form of metoclopramide that is swallowed. The boxed warning came after it was revealed that long-term use of the drug was linked to a serious involuntary movement disorder known as Tardive Dyskinesia. There is no known cure for the condition, and symptoms may persist even after the medication has been discontinued.

Source: The News & Observer

SOURCE: Reglan Side Effects › Salix plans to increase sales force to push new gastroparesis drug

Scleroderma is a chronic and disabling connective tissue disorder that involves changes in the skin, blood vessels, muscles and internal organs. For most, the condition is progressive. If the gastrointestinal tract, heart, kidneys or lungs are involved, the condition can be fatal. Secondary conditions resulting from scleroderma include gastroparesis and pulmonary hypertension.

The Scleroderma Research and Awareness Act, co-sponsored by Senator Charles Schumer (D-NY) gives hope to the 300,000 Americans and their families living with this disease. The legislation specifies:

1. Directing the National Institute of Arthritis and Musculoskeletal and Skin Diseases at the National Institutes of Health to expand research related to scleroderma. Priority areas would include:

• Development and evaluation of new treatments.
• Research on the relationship between scleroderma and secondary conditions including: pulmonary hypertension, gastroparesis, Raynaud’s phenomenon, and Sjogren’s syndrome.
• Establishment of family and “childhood-onset” patient registries.
• Support for the training of new investigators.

2. Directing the Centers for Disease Control and Prevention to establish a scleroderma public awareness campaign highlighting disease symptoms, prevalence, related conditions, and the importance of early diagnosis.

Treatment for scleroderma includes corticosteroids, immunosuppressants and NSAIDs. Other treatments for specific symptoms, such as heartburn and gastroparesis, include antacids or Reglan (metoclopramide), medicines to improve breathing, and blood pressure medications.

SOURCE: Reglan Side Effects › Scleroderma bill will raise awareness, fund research

Gastroparesis can cause symptoms such as abdominal pain, nausea, early fullness while eating meals and heartburn and can lead to weight loss and poor absorption of nutrients. Some studies have shown that women are as much as seven times more likely to suffer from gastroparesis than men, but the reason is unknown. It is also suspected that more people actually suffer from the condition because symptoms may overlap with other conditions such as irritable bowel syndrome and GERD.

Some people can manage their symptoms with diet or medication, while others may suffer so severely they may require hospitalization. Patients are usually instructed to avoid high-fiber foods, and others may require switching to a liquid diet to maintain hydration. Medication offers only temporary relief at best. For example, long term use of a popular treatment for gastroparesis, Reglan (metoclopramide), can result in a serious involuntary movement disorder called Tardive Dyskinesia.

The best defense to keep symptoms at bay, says Dr. Linda Lee, board certified in internal medicine and gastroenterology and director of the Johns Hopkins Integrative Medicine and Digestive Center, is following a low-fiber diet, taking medications in moderation, and addressing anxiety and depression, which can exacerbate symptoms.

SOURCE: Reglan Side Effects › Women more likely than men to suffer from gastroparesis

Gastroparesis is a digestive disorder in which the stomach takes too long to empty its contents. Literally, gastroparesis means “stomach paralysis,” and those who suffer from the condition can suffer a host of conditions including bloating, nausea, early fullness while eating meals, heartburn, and epigastric pain. Weight loss and poor absorption of nutrients are also serious are other serious outcomes of the disease.

Only a few medications are available to treat gastroparesis, including metoclopramide, domperidone, erythomycin and cisapride.

Metocloparmide, known in the U.S. by the brand name Reglan, works to stimulate stomach contraction. Reglan, however, has been linked to a serious and debilitating involuntary movement disorder called Tardive Dyskinesia, and now carries a black box warning.

Domperidone is similar to metoclopramide but does not carry the same risk of Tardive Dyskinesia. Domperidone is available in Mexico, Canada and some European countries but is not yet available in the U.S.

Erythomycin is a common antibiotic that works to stimulate receptors in the intestines and stomach. Most patients have a high likelihood of developing tolerance to the medication.

Cisapride is a medication that binds to serotonin receptors in the stomach wall and encourages the contraction of the stomach muscles. In the late 1990s, the medication was taken off the market because of complications of cardiac arrhythmia in patients who used the drug. The drug is back on the market for limited use and is not recommended for people with underlying kidney or heart disease.

An emerging therapy is showing promise for people who suffer from gastroparesis. Octreotide, a medication used to treat diarrhea, has been shown in a study among patients with scleroderma to speed up the emptying of stomach contents. Another study indicated the medication decreased the uncomfortable sensation of fullness following a meal. While the studies look promising, researchers say more studies are needed to determine if octreotide is a viable option for patients with gastroparesis.

Source: American College of Gastroenterology

SOURCE: Reglan Side Effects › Gastroparesis treatments offer little relief

The condition in which the stomach takes too long to empty its contents, most often is caused by diabetes but has been associated with infections, endocrine disorders, connective tissue disorders such as scleroderma, autoimmune conditions, neuromuscular diseases, cancer, radiation treatments applied to the chest or abdomen, some forms of chemotherapy, and surgery of the upper intestinal tract. People with eating disorders such as anorexia or bulimia may also develop gastroparesis.

Those with gastroparesis suffer from a host of symptoms such as discomfort of feeling too full too soon after eating a meal, heartburn, nausea and vomiting. Poorly digested food also can collect in the stomach and form a bezoar, a mass of undigested matter that may cause a blockage that can prevent the stomach from emptying, resulting in pain and nausea. The bothersome symptoms of gastroparesis can result in weight loss and poor absorption of nutrients, which makes diet and nutrition of the utmost importance to those with the condition.

Few medications are available for people with the condition, and most carry serious side effects. For example, Reglan (metocloparmide) was recently linked to a serious involuntary movement disorder known as Tardive Dyskinesia. The medication now carries a black box warning. Such warnings leave many searching for better ways to control their gastroparesis.

Some foods are more difficult for the stomach to digest, such as fatty or fibrous foods such as raw vegetables. People with gastroparesis should reduce their intake of fibrous foods or eliminate fiber from their diet altogether. If one chose to eat foods high in fiber, he should be sure to chew the food well and cook it until tender. If necessary, solid food can be pureed in a blender to ease digestion.

Thick and thin fluids such as puddings and nutritional drinks tend to pass well through the digestive tracts of those with the condition. Supplemental nutrition drinks are among the best choices for those with gastroparesis because they can provide important nutrients for the body that one may not be able to get with such a limited diet.

Source, American College of Gastroenterology

SOURCE: Reglan Side Effects › Diet, nutrition key for people with gastroparesis

The patient suffers fro gastroparesis, a condition in which the stomach empties its contents too slowly. It often affects people with diabetes. However, in as many as 60 percent of children with the condition, the cause is unknown.

The procedure involves inserting the pacemaker into the abdomen and placing the electrical wires attached to the device on the stomach. Electrical impulses stimulate the stomach after eating, encouraging the stomach to empty its contents.

“The initial settings are fairly low and, as with a pacemaker in the heart, we can change the settings as needed,” said pediatric surgeon Steven Teich, MD, surgical director of the Bariatric Surgery Program at Nationwide Children’s Hospital and clinical assistant professor of surgery at The Ohio State University College of Medicine.

Pacemakers have been used to treat gastroparesis in adults and results have been promising. “In patients who have received this type of treatment, nearly all symptoms were resolved within two weeks,” said said pediatric gastroenterologist Hayat Mousa, MD, medical director of the Motility Center at Nationwide Children’s Hospital and Associate Professor of Clinical Pediatrics at The Ohio State University College of Medicine.

The procedure takes the place of other, less effective treatments, commonly the medication metoclopramide known in the U.S. by the brand name Reglan. Reglan can only be used for short terms, as long-term use has been linked to a serious and debilitating involuntary movement disorder known as Tardive Dyskinesia. Earlier this year, the Food and Drug Administration (FDA) placed a black box warning on the medication alerting patients and health care professionals of the serious risk when using the medication for more than 12 weeks.

Other medications used to treat gastroparesis include antibiotics, which also carry a list of side effects. “None of these options are really that effective. Hence, the need for better treatment with the gastric pacemaker,” says Dr. DiLorenzo, Chief of Gastroenterology at Nationwide Children’s Hospital.

Source: DotMed News

SOURCE: Reglan Side Effects › Procedure shows promise versus drugs for children with gastroparesis

Gastroparesis is a disorder in which the stomach takes too long to empty its contents. It is the result of damage to the vagus nerve, which controls the movement of food through the digestive system. The most common cause of gastroparesis is diabetes, though it may also be caused by viral infections, eating disorders such as anorexia nervosa or bulimia, nervous system diseases such as Parkinson’s disease, gastroesophageal reflux disease, and certain metabolic disorders. In some cases, the cause is unknown.

An estimated 10 million people suffer from gastroparesis. Patients are often prescribed metoclopramide, a drug known in the U.S. by the brand name Reglan, to treat their condition. Recently, the Food and Drug Administration (FDA) issued a black box warning on metoclopramide/Reglan after an investigation found that patients who took the drug were at an increased risk of developing a severe involuntary movement disorder known as Tardive Dyskinesia. People treated with metoclopramide/Reglan for more than 12 weeks are at greater risk. The condition is often irreversible, even after the medication has been stopped.

With so few treatment options available to gastroparesis sufferers, the Gastroparesis Awareness Campaign Organization is using this month to push for funding to help find new medications to treat the millions of people who suffer from gastroparesis. “We will be having additional fund raisers this year as well sending out care packets to help bring smiles to those suffering with gastroparesis,” states the organization’s Web site. “Together, we will fight for a cure!”

SOURCE: Reglan Side Effects › August is Gastroparesis Awareness Month

Tranzyme Pharma’s

TZP-102 is an oral medication. Tranzyme’s equivalent medication, TZP-101, a drug given by IV in a hospital setting, has been put on hold by the company. While the drug showed promising results in phase II trials, the company hopes to buy time until the markets improve and the cost of capital drops.

Diabetic gastroparesis is a disorder in which the stomach takes too long to empty its contents. It affects people with both type 1 and type 2 diabetes. The condition is often treated with metoclopramide, sold in the U.S. under the brand name Reglan. Earlier this year, the FDA required manufacturers of metoclopramide to put a black box warning on the  medication warning health care providers and consumers of the risk of a serious involuntary movement disorder known as Tardive Dyskinesia.

Patients who suffer from Tardive Dyskinesia experience such as lip smacking, tongue thrusting, eye blinking and bulging, head jerking, facial grimacing, pucker and pursing of the lips and involuntary movements of the fingers. The condition is often irreversible even after medication has been stopped.

Analysts say a new treatment for diabetic gastroparesis would be welcome in an area where few treatments are currently available.

Source: Biz Journals

SOURCE: Reglan Side Effects › New treatment for gastroparesis granted FDA ‘fast-track’ status

Earlier this year the Food and Drug Administration (FDA) issued a black box warning on Reglan to warn of the increased risk of the movement condition known as Tardive Dyskinesia. The condition is more pronounced in individuals who take the medication for more than 12 weeks. Tardive Dyskinesia is identified by involuntary movements of the muscles that include eye blinking and bulging, head jerking, lip smacking, tongue thrusting, facial grimacing, puckering and pursing of the lips and involuntary movements of the fingers.

The condition may be permanent even after the medication has been stopped. The medication also may mask the symptoms of the condition, which often get worse after the drug is discontinued.

While the elderly are most at risk, children, like Joey, can suffer serious side effects as well. “My son has been through a lot. He has had problems at school and has had a lot of other children asking him why do you blink your eyes and jerk your head. He has been to many doctors and put on several types of medicines. He has also been diagnosed with severe anxiety, which is also a side effect of this drug,” his mother says. “I would advise anyone taking this drug to stop immediately! The side effects are permanent and are very life altering. This drug is dangerous and the FDA needs made responsible for all the sufferers out there. Don’t let the FDA fool you…they have known about these symptoms since 1984…I have done my research!”

* names have been changed

SOURCE: Reglan Side Effects › Reglan side effects leave young boy with serious movement disorder

Earlier this year the FDA placed a black box warning – the sternest warning it can require –on Reglan after reports of users of Reglan began suffering from a serious and debilitating involuntary movement disorder known as Tardive Dyskinesia. Those who suffer from the condition develop involuntary movements of the muscles, such as lip smacking, tongue thrusting, eye blinking and bulging, head jerking, facial grimacing, puckering and pursing of the lips, and involuntary movements of the fingers.

Those who take Reglan for more than 12 weeks are at greater risk of developing Tardive Dyskinesia, thus the new labeling advises against long-term use except in rare cases where the benefit outweighs the risks.

Given the black box warning now on Reglan, sufferers of digestive problems may want to turn to old-fashioned, natural alternatives. For example, ginger root aides in digestion and licorice root soothes mucous membranes along the GI tract. Peppermint settles the stomach and aides in the production of saliva. And Rubarb works to rid excessive mucous in the intestines.

For more information, visit your local health food store. And always be sure to discuss any medication or diet changes with your health care provider.

Source: Examiner

SOURCE: Reglan Side Effects › Reglan users may want to consider natural remedies

The watchdog group sifted through assessments based on reviews of published data from medical journals and unpublished data from the USA, and has cataloged 136 commonly prescribed drugs that can produce symptoms of dementia or delirium. Dementia is a memory disorder. Delirium involves sudden changes to vision, hearing and thinking. Reports show that in many cases, doctors overlook the possibility that a patient’s medications may be causing his dementia or delirium.

The elderly are at greater risk of adverse events from medications, possibly due to a build-up in higher doses of medication in their bodies due to decreased kidney or liver function. Older adults also may take multiple drugs that could interact and produce unusual side effects. Furthermore, those suffering from a cognitive impairment are more likely to have their problem worsened by medications. Their symptoms also may be overlooked by physicians as symptoms of aging.

One such adverse event is a serious involuntary movement disorder, much like Parkinson’s disease, called Tardive Dyskinesia. The condition has been linked to long-term use of Reglan (metoclopramide) as well as some antidepressants. The elderly are especially susceptible to Tardive Dyskinesia.

Source: Natural News

SOURCE: Reglan Side Effects › Watchdog group catalogs 136 meds that can cause dementia, delirium

Metoclopramide accelerates food absorption and may slow the emptying of solids, thus diabetics may need to increase insulin doses. The drug also may reduce the absorption of medications, such as the heart medication digoxin. The drug also has been linked to a serious movement disorder known as Tardive Dyskinesia. Concurrent use of phenothiazine and butyrophenone tranqulizers should be avoided because they increase the potential for Tardive Dyskinesia. The condition causes involuntary muscle spasms, motor restlessness and inappropriate aggression.

Earlier this year the Food and Drug Administratin (FDA) issued a black box warning on Reglan (metoclopramide) for the risk of Tardive Dyskinesia with long-term use of the medication. The elderly are at higher risk of experiencing side effects, in particular Tardive Dyskinesia. Dosage may need to be adjusted in older patients with impaired kidney function. Children may experience muscles spasms and Tardive Dyskinesia as well as blood problems if they take high doses of the medication.

Individuals who have suffered side effects after taking Reglan (metoclopramide) should contact their physicians. They may also have a lawsuit against the manufacturers of the medication.

The Merck Veterinary Journal
iVillage: Your Total Health

SOURCE: Reglan Side Effects › Prokinetic drugs like Reglan have list of side effects

While researchers are calling this encouraging news to pregnant women, the U.S. Food and Drug Administration (FDA) says more studies must be conducted before the agency will grant approval for the drug to be used in the treatment of morning sickness. After all, the drug carries a black box warning to consumers and health care providers of a serious, debilitating and often irreversible movement disorder called Tardive Dyskinesia. Other problems, it appears, may occur when the medication is taken on a long-term basis, even for pregnant women. 

According to the Canadian research, the length of time on the drug seemed to play a role in the likelihood of birth defects. Children from mothers who took the drug just one week during the first trimester had a 4.9 percent birth defects rate, while babies from mothers who used the drug for more than three months had a 6.1 percent rate of birth defects.

Reglan is approved in the U.S. by the FDA to treat heartburn and a condition known as diabetic gastroparesis. Earlier this year, the FDA issued a black box warning on the medication warning of the increased risk of Tardive Dyskinesia. Individuals who take the medication for longer than 12 weeks are at greatest risk of developing the condition. Elderly women, especially women, are also at greater risk than the general population. Some studies put the risk as high as 20 percent among long-term uses of Reglan.

Source: Calorie Lab

SOURCE: Reglan Side Effects › Study: Effect of Reglan on increased risk of birth defects

Some patients with gastroparesis don’t respond to treatment and some may experience severe adverse events from the medication. For example, Reglan recently fell under a black box warning after reports of a serious movement disorder called Tardive Dyskinesia in some patients who took the medication. Given the risks of medication, alternative therapies like the stimulation device seem more attractive. 

During a six-month study of 34 patients with the meal-activated nerve stimulators, researchers also found that patients lost about 10 pounds and two inches from their waistline, suggesting the device may also aid in weight loss.

The device, Tantalus, manufactured by MetaCure, is made up of three electrodes that attach at one end to a pulse generator and at the other end to the distal stomach. As the device senses food intake, it transmits an electrical current to the stomach to stimulate gastric contraction.

“The minimally invasive approach combined with a low incidence of adverse events presents a potential benefit that may position this system as a valid treatment for type 2 diabetes,” says Dr. Arthur Bohdajlian, of the Medical University of Vienna in Austria. “Additional clinical benefits on conditions related to metabolic syndrome are currently being analyzed.”

The device is approved in Europe for the treatment of obesity and the management of type 2 diabetes in obese patients.

SOURCE: Reglan Side Effects › Device offers alternative treatment for gastroparesis

Tardive Dyskinesia (TD) is a disfiguring disorder characterized by involuntary movements of the face, tongue or extremities. Symptoms can include lip smacking, tongue thrusting, eye blinking and bulging, head jerking, facial grimacing, puckering and pursing of the lips, and involuntary movements of the fingers. The symptoms do not always go away after discontinuation of the medication.

The new labeling warns consumers and health care providers that the risk of developing TD increases with duration of treatment and total cumulative dose.

“Although the risk of TD with metoclopramide has not been extensively studied, one published study reported a TD prevalence of 20 percent among patients treated for at least 12 weeks,” the new warning states.

The labeling warns consumers and health care providers not to use the treatment for more than 12 weeks except in rare cases where the therapeutic benefit outweighs the risk of developing TD. Elderly are at greater risk, but any patient who develops signs of symptoms should stop taking the medication immediately. Metoclopramide may also suppress or partially suppress the signs of TD, thereby masking the underlying disease process.

If you or a loved one have been injured by Reglan side effects, you may have a claim against the manufacturer.

Source: FDA

SOURCE: Reglan Side Effects › FDA approves Reglan label changes to reflect black box warning

Tardive Dyskinesia is a serious movement disorder caused by Reglan that often persists long after the medication has been stopped. People with the condition generally experience involuntary movements of the face, tongue or extremities. There is no known effective treatment for Tardive Dyskinesia.

While it is hard to predict which patients are likely to develop the syndrome, both the risk of developing the condition and the likelihood that it will become irreversible are believed to increase with the duration of treatment and the total cumulative dose. Those most at risk, however, appear to be the elderly, especially elderly women.

Reglan should be discontinued in patients who develop signs or symptoms of Tardive Dyskinesia. Prolonged treatment – greater than 12 weeks – with Reglan should be avoided in all but rare cases where therapeutic benefit is thought to outweigh the risks to the patient.

Source: FDA

SOURCE: Reglan Side Effects › Study: 20 percent of long-term Reglan users develop Tardive Dyskinesia

HD symptoms include changes in personality, cognition and physical skills. Almost all patients with HD exhibit physical symptoms such as jerky, random and uncontrollable movements. Many HD patients who were prescribed Reglan “have experienced not only symptoms of neuroleptic malignant syndrome (NMS) and/or Tardive Dyskinesia, but (also) hallucinations, paranoia, suicidal thoughts, severe anger outburts, etc.,” according to Jean E. Miller, a contributor editor for HD Lighthouse, an information center and community for patients with HD and their family members. “In one HD patient, the serious side effects still hadn’t gone away 18 months after taking Reglan.”

Earlier this year the Food and Drug Administration ordered the makers of Reglan (metoclopramide) to include a black box warning on the product label warning of the risk of Tardive Dyskinesia with long-term, high-dose use of the drug. Tardive Dyskinesia is a condition in which the body moves repetitively and uncontrollably. The condition often continues even after the medication has been discontinued.

Miller says she hopes the black box warning on Reglan will make physicians more cautious when prescribing the medication for patients with HD. She also urges familys of HD patients to “exercise caution when a physician wants this medication prescribed, especially for those in the later stages of HD or on feeding tubes.”

SOURCE: Reglan Side Effects › Tardive dyskinesia in Huntington disease patients on Reglan

Tardive Dyskinesia is a neurological syndrome caused by the long-term use of neuroleptic drugs generally prescribed for psychiatric disorders, and some gastrointestinal disorders, such as metoclopramide, commonly known by the brand name Reglan. The condition causes repetitive, involuntary movements that may include grimacing; tongue protrusion; lip smacking, puckering and pursing; and rapid eye blinking. Rapid movements of the fingers, arms, legs and trunk may also occur.

There is no standard treatment for Tardive Dyskinesia. The first step is to stop or minimize the medication that is causing the condition. Symptoms of Tardive Dyskinesia may linger long after discontinuation of the drugs, however with some careful management, some symptoms may improve and/or disappear over time.

If you or a loved one has been injured by neuroleptic drugs like metoclopramide or Reglan, you may have a claim against the manufacturer and may want to seek legal consel.

SOURCE: Reglan Side Effects › Clinical trials seek treatment for Tardive Dyskinesia