Tibotec Therapeutics

Early this year, Intelence was approved by the the Food and Drug Administration (FDA) for use in the treatment of HIV. At that time, data indicated a slight risk of SJS.

SJS, and its most severe form, toxic epidermal necrolysis, TEN, are identified by a rash on the skin that blisters over causing the skin to peel off in sheets. The condition is extremely painful and often requires hospitalization to treat the open wounds on the skin, mouth, eyes and other mucous membranes. Complications include infection, dehydration, vision problems, organ dysfunction and death.

SJS and TEN is a severe adverse reaction to medication. Some of the dugs most commonly associated with SJS and TEN include ibuprofen, antibiotics, and anti-seizure and anti-viral medicines.

Tibotec Therapeutics, in cooperation with the (FDA), issued a Dear Healthcare Professional Letter informing them that the WARNINGS and PRECAUTIONS sections of the drug information was updated to include warnings of severe skin and hypersensitivity reactions from use of Intelence (etravirine).

The letter urged health care providers to discontinues the medication immediately if signs or symptoms of severe skin reactions or hypersensitivity reactions develop including but not limited to severe rash or rash accompanied by fever, general malaise, fatigue, muscle or joint aches, blisters, oral lesions, conjunctivitis, facial edema, hepatitis, and eosinophilia.

A delay in stopping the treatment after the onset of a severe rash may result in a life-threatening reaction.

SOURCE: Stevens Johnson Syndrome › HIV drug linked to deadly skin condition

More than 200 medications have been associated with SJS/TEN, most commonly antibiotics, non-steroidal anti-inflammatory drugs (NSAIDS), and medication to treat seizures. SJS/TEN presents as a rash on the skin that blisters over and causes the skin to peel away much like that of a burn victim. Blisters can form in the mouth, on the eyes, and on internal organs, leading to dehydration, ocular problems including blindness, and in more severe cases, death.

Lamictal ODT was recently approved for use in the treatment of epilepsy and bipolar disorder by the Food and Drug Administration (FDA) and is available in 25 mg, 50 mg, 100 mg and 200 mg strengths. The medication is expected to be available to consumers this month. Lamictal ODT matches the dosage of Lamictal tablets. Lamictal tablets carry the same warning of SJS/TEN.

Source: Monthly Prescribing Reference

SOURCE: Stevens Johnson Syndrome › Epilepsy, bipolar drug linked to rare skin reaction

Joe, a diabetic, was given the antibiotic Vancomycin to treat a foot infection. But the antibiotic made him sicker than the initial infection. A rash developed over Joe’s body and his skin began to blister over and peel away. The blisters formed inside his throat, causing excruciating pain and making drinking difficult. He was at risk for dehydration. Joe was hospitalized for eight days. His blood pressure dropped and his blood sugar sky rocketed. His wife was desperate to find something Joe could keep down to help speed his recovery, and that is when she went to Razzleberry’s.

Kaczocha told the Knoxville News Sentinel, “I asked, ‘Where’s your husband?’ And she told me what happened. I said, ‘Why don’t you take him a little Lemon Ice to comfort him?’ I thought it might be soothing to his throat.” The Lemon Ice worked like charm. Joe was soon able to expand to other flavors. After eight days, he was able to leave the hospital.

More than 200 drugs have been linked to SJS, most commonly antibiotics, ibuprofen and anti-seizure medication. While some medications list the warnings in fine print on their labels, people who have suffered from the condition argue that they were never fully warned of the potential dangers. If you or a loved one have been diagnosed with SJS, you may have a claim against the manufacturer.

SOURCE: Stevens Johnson Syndrome › SJS victim says ice cream led him to a speedy recovery

SJS is rare and has been associated with more than 200 medications. Most commonly, it is caused by a reaction to antibiotics, ibuprofen or anti-seizure medication. People with SJS develop a rash on their skin which blisters over, causing the skin to peel off in sheets. Blisters can form in the eyes, internal organs and mouth, which can lead to blindness, organ failure and even death.

Charlie is a 14-year-old from Throntree, Middlesborough who first developed the condition five years ago after a family trip to Greece. The blisters started in his mouth and spread throughout his body and in his eyes. It was baffling to doctors and devastating to family. They still don’t know what medications triggered the attack, but he has suffered more attacks over the years. Two years ago it was so bad, Charlie says he thought he was going to die.

Charlie’s feature in The Real A&E involves an emergency room visit in which Charlie suffers from a nosebleed that won’t stop. His father, who took him to the emergency room, worried that the nosebleed was the first sign of a new onset of SJS. The doctors cauterize the blood vessels in his nostril.

Charlie says he hopes his TV appearance will help educate others about the rare but life-threatening condition known as SJS.

Source: Gazette Live

SOURCE: Stevens Johnson Syndrome › Young SJS survivor is featured on Sky TV show The Real A&E

The safety information comes from routine pharmacovigilance activities of clinical study and post marketing reports.

Tarceva monotherapy is indicated for the treatment of patients who have locally advanced or metastic non-small cell lung cancer after failure of at least one prior chemotherapy regimen. In combination with gemcitabine, erlotinib also is indicated for the first-line treatment of patients with locally advanced, unresectable, or metastic pancreatic cancer.

SJS/TEN is a severe adverse reaction that has been linked to more than 200 medications. It is most commonly associated with ibuprofen, antibiotics and anti-seizure medication. SJS/TEN is rare but life-threatening, causing a rash to form on the skin. The rash blisters over and the skin peels off in sheets. In some, as much as 90 percent of the skin can peel away, leaving the victim susceptible to infection. Patients are often treated in burn units and put into a drug-induced coma to help ward off infection. Blisters also can form on the mucus membranes, such as the eyes, mouth and internal organs, causing dehydrations and ocular problems.

Source: FDA

SOURCE: Stevens Johnson Syndrome › Cancer drug linked to serious skin condition SJS/TEN

SJS is a severe adverse reaction to medication. For Rachel, it was two doses of ibuprofen purchased from a grocery store. Two weeks later, her body reacted violently, developing rashes on her skin that blistered over and peeled off. She was admitted to the hospital and placed in a drug-induced coma while doctors worked to save her life. Her peeled body resembled a burn victim’s and she was prone to infection and other serious problems. After her months-long recovery, Rachel returned home and made her first video.

The road of recovery has not been easy. Rachel talks about her bout with depression and the gradual improvement of her skin and growth of hair. In some videos she is mad or sad. In others, she sounds upbeat. In her most recent video, Rachel has just returned from vacation and the trip sounds therapeutic.

“I’m hoping for the best,” she says.

She may think her videos fall on deaf ears, but a recent commenter made her realize just how important her message is to others who struggle with the condition.

“I wasn’t going to make another video until I saw this girl Shawnee’s video. And she told me I was an inspiration to her,” she says. “So I’m going to continue making videos until I feel as though it has been enough.”

Watch Rachel’s latest video below:

SOURCE: Stevens Johnson Syndrome › Rachel continues on road to recovery from SJS

Blisters also formed on his eyes, causing his eyelids to fuse closed. Ophthalmologists tried to pry his eyes open but it wasn’t until 17 days later that James was able to open his eyes. The damage had been done. His left eye was so badly scarred that even now he can’t bear to go without sunglasses, even indoors. And he cannot make his own tears, which exacerbates his condition.

James’ condition, toxic epidermal necrolysis, TEN, is the most severe form of Stevens Johnson Syndrome, SJS, a severe adverse reaction to medication. Many medications have been linked to SJS and TEN, most often ibuprofen, anti-seizure medication and antibiotics. Many medications have warnings listed in the fine print of the packaging, but those warnings often go unnoticed and can even be misdiagnosed by doctors. Early diagnosis and treatment can be key to survival.

Now 7 years old, James’ medical costs and treatments are mounting and his parents worry how they will provide for him in the months and years to come. Doctors say their son needs eye surgery to prevent his lashes from growing inward and irritating his eye further. Both James’ parents work at a hospital but their health insurance plan no longer covers the boy’s treatment. Now they have to rely on the kindness of strangers to get their son the treatment he needs. Luckily, just last week, the Dubai branch of the Moorfields, the UK’s top eye hospital, offered to examine James free of charge.

“This nasty condition is essentially untreatable,” said Dr. Chris Canning, the chief executive and medical director at the hospital. “There is no miracle cure anywhere in the world but there are things that can be done to make life easier for James.”

James’ mother is thankful but she still feels helpless. “If I could only give my tears to my child, I would be happy,” she said.

Source: The National

SOURCE: Stevens Johnson Syndrome › Boy suffering with SJS/TEN receives free exam from hospital

Detrol is just one of the medications that has been added to the Food and Drug Administration (FDA) quarterly report on treatments identified as a potential safety risk to patients. According to the report, Detrol, also known as Tolterodine Tartrate, is being evaluated by the agency after reports of patients diagnosed with Stevens Johnson Syndrome (SJS), a rare but life-threatening skin condition, after taking the medication.

SJS and its most severe form, toxic epidermal necrolysis (TEN), are severe adverse reactions to medications. More than 200 medications have been linked to the condition. Those who suffer from SJS or TEN experience rashes that blister over and cause the skin to peel off in sheets. Blisters can also form on the eyes, inside the mouth and on internal organs, causing ocular problems, dehydration, infection and sometimes death.

Other medications listed in the FDA’s quarterly report and investigated for a possible link to skin reactions include hydrochlorothiazide in combination with other products, sleep disorder medications modafinil (Provigil) and Armodafinil (Nuvigil), and smoking cessation drug Chantix.

The FDA reports that it is continuing to evaluate these issues to determine if there is need for regulatory action. In the interim, the FDA emphasizes that the listing of a drug and a potential safety issue does not mean that the medicines should not be prescribed nor that patients taking those drugs should stop taking the medication. Patients with questions about their medication should contact their health care provider.

Source: FDA

SOURCE: Stevens Johnson Syndrome › New drugs investigated for possible skin reactions

SJS, or its most severe form, TEN, toxic epidermal necrolysis, is caused by a severe adverse reaction to medication, most commonly ibuprofen, antibiotics and anti-seizure drugs. More than 200 medicines have been associated with SJS/TEN, but few people are aware of the condition. Warnings of the risk of SJS/TEN often can be found in the fine print of the medicine’s insert or packaging. But even doctors can have a difficult time diagnosing the painful condition.

SJS/TEN usually begins with a rash on the skin that can blister over, causing the skin to peel off in sheets. Mucous membranes can be affected, causing blisters on the eyes and inside the mouth. Dehydration, ocular complications and infection can result. Patients suffering from SJS/TEN are usually treated in burn units, as was Cloanne, who died at the University of Utah Hospital Burn Center.

The premature death of Cloanne has deeply touched her family, who says she “will be missed by many, many people. She loved doing and caring for others; whether it be doing a little shopping for the perfect outfit or being of service by babysitting and spending time visiting.”

SOURCE: Stevens Johnson Syndrome › Utah woman dies from complications of SJS

Patricia Roberts is a survivor of two bouts of Stevens Johnson Syndrome (SJS), a rare but life-threatening condition caused by an adverse reaction to common medication. The condition presents with a rash on the skin that blisters over and causes the skin to peel off in sheets. Victims are susceptible to infection and are often treated in burn units. Blisters also can form in the mouth or on the eyes, which can lead to dehydration or vision problems.

When Roberts heard the story of 4-year-old Ali Ghazi, who also suffered from SJS, she felt moved to help. His had painful sores on his eyes that kept him from opening his eyes. As a result, his eyelids fused together.

Sixty years his senior, Roberts says she feels for the boy. “All I want is for him to be able to see the world again,” she said in a story in Horsforth Today.

Roberts, who was treated for SJS last December, has teamed up with other survivors of SJS to raise money to bring Ali to England for treatment. So far, she has raised 5,000 pounds but says another 50,000 pounds is needed to get him the treatment he needs to see again.

“I was in pain and scared, and I’m a grownup. How does a 4-year-old feel?” she said. “At least we can do something to stop the pain he’s in.”

SOURCE: Stevens Johnson Syndrome › Woman raises money to help Pakistani boy with SJS

Amy Lightfoot, was diagnosed with SJS in January and spent several weeks in the critical are unit at Nottingham City Hospital until her death last March. SJS is a rare but life-threatening condition in which a rash forms on top layer of skin, blisters over and peels away. Blisters can also form on the eyes, throat, mouth and internal organs. SJS is a severe adverse reaction to medication, such as ibuprofen, antibiotics and anti-seizure medication.

The recordings will be sold along with a CD by the band No Eyed Deer, of which Amy and her boyfriend Lee Brown were members. Amy’s parents say selling the music to raise money for the hospital is a perfect way to give back to the hospital that cared for her.

“The staff who treated Amy at the hospital were just fantastic, but being there for so long makes you realize the cost of the equipment they are using – a ventilator alone costs about 30,000 pounds,” Amy’s mother Carol said.

Carol said she was previously unaware of her daughter’s recordings, which are titled Satellite and Waiting. “They were done while she was studying at the Joseph Wright Centre and we thought releasing them would be a nice way of remembering Amy, while raising money at the same time,” she said.

SOURCE: Stevens Johnson Syndrome › Family who lost daughter to SJS releases songs for charity

Thanks to medical innovations, Jenny, who lives in Dublin, underwent surgery a month ago to restore her sight by inserting an artificial cornea in her right eye. The woman was doubtful but hopeful. Doctors had closed a flap of skin over the cornea as she healed from surgery. Last week they removed the skin. “What a shock,” Jenny said. “I just can’t believe it actually happened… it’s all my dreams together, but at the same time I wasn’t hoping for it, you know. I was afraid to.”

The Royal Victoria Eye and Ear Hospital in Dublin, Ireland performed the surgery known as Boston keratoprosthesis. The procedure is rare in Ireland; only about 13 of the procedures have been performed there. Doctors said Jenny’s case was rare because she had been without vision for so long.

Thanks to the surgery, Jenny was able to read numbers and letters for the first time in 46 years. But most remarkably, she was finally able to see the faces of her husband and children.

Source:
Irish Times

SOURCE: Stevens Johnson Syndrome › SJS victim’s sight restored after 46 years

The new information, gathered from a clinical study and postmarketing reports, revealed sometimes fatal incidences of gastrointestinal perforation, bullous, blistering and exfoliative skin conditions including cases suggestive of Stevens Johnson Syndrome (SJS) and/or toxic epidermal necrolysis (TEN) and ocular disorders including corneal perforation or ulceration.

SJS/TEN is a rare but life-threatening reaction to medication that presents with a rash that blisters over, causing the skin to peel off in sheets. It can also affect the mucus membranes, causing blistering and ulceration of the mouth, eyes and internal organs. Several commonly used medications have been linked to SJS/TEN including ibuprofen, antibiotics and antiviral drugs.

Tarceva is used in the treatment of locally advanced or metastic non-small cell lung cancer after failure of at least one prior chemotherapy regimen. It is also indicated for the first-line treatment of patients with locally advanced, unresectable or metastatic pancreatic cancer.

The updated WARNINGS AND PRECAUTIONS section of the labeling reflects dose interruption and/or discontinuation instructions. For any questions, or to report adverse events suspected to be associated with the use of Tarceva, call 1-877-TARCEVA (1-877-827-2382).

Alternatively, adverse event information may be reported to the FDA’s MedWatch reporting system by phone at 1-800-FDA-1088, by facsimile at 1-800-FDA-0178, by mail to MedWatch, HF-2, FDA, 5600 Fishers Lane, Rockville, MD 20857, or by the internet at http://www.fda.gov/medwatch/index.html.

SOURCE: Stevens Johnson Syndrome › New SJS warnings added to cancer treatment drug

SJS is a serious condition. It is most identified by a rash on the skin. The rash can blister and peel away, giving victims the appearance of having fourth degree burns. Many are treated in burn units. Blisters can form on mucus membranes such as the eyes and throat making it difficult and painful for patients to eat, drink or void. Eye conditions and even blindness can occur. In more severe cases, SJS can cause seizures, coma and even death. In some cases, rashes and lesions may never appear, and often the condition goes undiagnosed until it is too late.

Several common prescription and over-the-counter medications have been linked to SJS, including ibuprofen, anti-seizure medicines and antibiotics. Not all drug labels provide current warnings about medical risks. For example, Motrin provided a warning of SJS on its label when the medication was only available by prescription. The over-the-counter Motrin product does not provide a warning on its label.

If you experience any symptoms of SJS, contact your doctor and ask to be taken off the medication. You may also want to consult with a product liability lawyer, as many are accepting legal cases to submit lawsuits against the makers of the drug companies for failing to adequately warn consumers of the risk for this serious adverse reactions to their medications.

SOURCE: Stevens Johnson Syndrome › Beasley Allen attorney warns public of serious adverse drug reactions

Cripps has been sharing updates on his sister’s condition in his newspaper column. This latest update continues to show the family’s optimism for her full recovery. Her doctors say it could take six months for her body to heal completely.

“Skin continues to peel away from her body and the new layer is extremely sensitive,” Cripps writes. “She will work with a dermatologist on best procedures to expedite recovery. The precautions she takes with her new skin will be similar to how a mother cares for her newborn, especially with heat and the sun.”

Cripps gives credit to the hospital staff for taking good care of his sister. “I know a lot of people think the health care system is in crisis. All I can say is my sister received an amazing level of care, from initial prognosis of the SJS in Royal Victoria Hospital in Barrie to the specialized burn unit at Sunnybrook Hospital,” he writes.

Lisa deserves much credit too. Her strong will and positive spirit surely helped bring on a speedy recovery.

SOURCE: Stevens Johnson Syndrome › Canadian woman with SJS goes home from hospital

Cephalon, makers of Treanda, has filed documents with the Securities and Exchange Commission this week stating it will update its prescribing information for the Treanda drug to include a warning of the possibility of SJS when used with allopurinol, a medication used to treat excess uric acid in the blood plasma, according to the Philadelphia Business Journal.

According to the documents, two patients treated with Treanda and allopurinol were diagnosed with SJS. One of the two died.

SJS is a rare but life-threatening condition in which a rash forms on the skin and blisters over. The skin peels off, leaving the skin exposed to infection. Blisters also can form on mucus membranes such as the eyes and mouth, which can lead to dehydration and vision problems. More than 200 medications have been linked to SJS.

“Although the relationship between Treanda and Stevens Johnson Syndrome cannot be determined, there may be an increased risk of severe skin toxicity when Treanda and allopurinol are administered concomitantly,” Cephalon stated in its filing, adding that allopurinal is known to cause the syndrome.

The updated prescribing information is expected to be implemented in early May.

SOURCE: Stevens Johnson Syndrome › Cancer drug’s prescribing information to include warning of SJS

Common side effects of Tamiflu and Relenza include dizziness, vomiting and diarrhea. Other, more serious adverse reactions are rare but can occur, including Stevens Johnson Syndrome, or SJS. SJS is a rare reaction to medication that begins with rashes on the skin that blister over, causing the skin to peel off in sheets. Blisters also can form on the eyes and mouth, which can lead to ocular problems, dehydration, infection and, in severe cases, death.

In Hong Kong in particular, pharmacists are urging the public not to stock up on the antiviral medications, as they say the Chinese government has plenty of the medicines in stock to combat a pandemic should one arise. The urgings come just six years after the deadly SARS virus struck that nation. About 400 Chinese pharmacies – or 95 percent of the market – have joined a campaign to keep residents’ fears at bay. There have been no swine flu cases reported in Hong Kong to date.

“The pharmacies will advise individuals whether the symptoms they have reflect a cold or something more serious such as flu,” head of Pharmacovigilance Kevin Cheung Kin-man told The Standard. “If the symptoms persist for days, people will be advised to consult a doctor. In the meantime, in the case of colds, pharmacists will be able to recommend appropriate over-the- counter medication.”

SOURCE: Stevens Johnson Syndrome › Pharmacists warn against use of anti-virals amid swine flu scare

Lisa had become ill with SJS after taking antibiotics prescribed to her following minor surgery. SJS is a rare but life threatening condition that begins with a rash that blisters over, causing the skin to peel off in sheets. The eyes and mucus membranes also can be affected, causing ocular complications and vision loss. More than 200 medications have been linked to SJS, most often antibiotics, ibuprofen and anti-seizure medication.

Like others with SJS, Lisa was moved to a burn unit. There, her blisters multiplied and covered her face, torso, legs and arms. They gradually scabbed over. Her eyes also were affected, but a specialist deemed damage to her vision was minimal. The blisters in her mouth, tongue and throat made eating and drinking excruciatingly painful, but she worked hard to drink supplemental beverages so that she could nourish her body. The alternative was a feeding tube.

Her first few days in the hospital were most crucial, as there was the possibility her condition could worsen to a condition known as toxic epidermal necrolysis, or TEN.

“It took everything in my power to hold back the tears during the 30-minute visit. While I was torn up inside, I didn’t want to show my sorrow for fear it would make her feel worse than she already did. I wanted to be strong for her,” Mark writes.

Lisa continues to improve, and Mark says he is hopeful he will be sitting around a campfire soon, “enjoying a beverage and counting our blessings,” he says.

SOURCE: Stevens Johnson Syndrome › Update on newspaper editor’s sister with SJS

As a young child, Lisa contracted pneumonia and spent a month in the hospital. She grew up with an abusive stepmother and struggled through a difficult marriage. Despite the obstacles, she managed to raise two children and find a career in real estate. But last week, the young woman with an infectious personality, hit another road block. She was diagnosed with Stevens Johnson Syndrome (SJS), an adverse reaction to antibiotics prescribed to her following minor surgery.

SJS is a rare but life-threatening hypersensitivity disorder that presents with a rash on the skin. As the condition progresses, the rash blisters over and the skin begins to peel off in sheets. This causes great pain and makes the body prone to infection. Most patients are treated in burn units. The mucus membranes also can be affected, causing blisters to form in the mouth and on the eyes. Dehydration and ocular problems become serious side effects. Severe cases of SJS can be fatal.

More than 200 medications have been linked to SJS or its most severe form, toxic epidermal necrylosis (TEN), most commonly antibiotics, ibuprofen and anti-seizure medication. SJS and TEN doesn’t discriminate based on age or gender. The warnings on the medications’ label often go unnoticed. And the condition is so rare that it can be hard to diagnose.

Some organizations, such as the Stevens Johnson Syndrome Foundation seek to raise awareness and “provide information about adverse allergic drug reactions so a quick diagnosis can be made and the offending drug stopped as soon as possible.”

When Mark visited his sister Lisa, she was covered from head to toe with blisters and rashes. Despite her condition, she seems brave. “That’s why she’s my hero,” Mark says.

Mark Cripps is Managing Editor for the Dundas Star News, the Ontario, Canada newspaper where he shared the story of his sister.

SOURCE: Stevens Johnson Syndrome › Newspaper managing editor calls sister with SJS a hero

SJS is a rare but life-threatening disorder usually caused by an adverse reaction to common medication such as antibiotics, anti-seizure medication and ibuprofen. SJS is a hypersensitivity disorder that presents with a rash on the skin that blisters over causing the skin to peel off in sheets. Mucus membranes also can be affected, with blisters developing on the eyes and in the mouth which can lead to ocular problems, dehydration, infection and even death.

Rachel’s videos show her gradual physical progress. What we see is that surviving the condition is the first hurdle. The next is the physical recovery – as the skin heals and the hair grows back. The emotional recovery can take longer, and Rachel shares that promise and pain in her last two videos from February 2, and April 9.

Rachel tells us that she feels physically stronger every day. She is in therapy now to deal with the depression that makes her “fight the urge every day not to cry.” She has noticed those closest to her drift away or change the way they treat her. One blessing is a friend she has found who suffered from SJS five years ago. The friend shared a picture of herself – completely physically healed from the peeled-off skin and hairlessness. It gives Rachel hope that she, too, will look like her old self again.

Her video testimonials are honest and real, and not only serve as a healing mechanism for her, but a way for her to help others. The videos, she says, “may benefit somebody in the future.”

SOURCE: Stevens Johnson Syndrome › SpunkyRachel discusses physical, emotional healing from SJS

Shchekochikhin died July 3, 2003 at the age of 53 following a brief illness. His symptoms were similar to poisoning by radioactive materials that raised speculation that the journalist may have been purposely poisoned. Shchekochikhin wrote about and campaigned against organized crime and corruption.

In the years leading up to his death he had written a series of investigative articles on a Moscow furniture store allegedly at the center of a money laundering scheme that involved FSB officials. His last story on the subject detailed the murder of a key witness in the case. Two weeks later, Shchekochikhin fell ill.

According to CPJ: Committee to Protect Journalists, Shchekochikhin’s illness began with flu-like symptoms including fever, sore throat, body aches and a general burning sensation. He was diagnosed with an acute respiratory viral infection. His condition continued to decline and four days later, on June 21, 2003, he was admitted to the hospital. His symptoms worsened. His hair to fell out, his skin began to peel away and his organs started to fail. He died two weeks later. Doctors said he was suffering from an allergic reaction but his condition remained a “medical secret.”

According to Reuters, Russian investigators claim medical tests revealed no narcotics, psychotropics, strong poisons or heavy metals in Shchekochikhin’s body.

“No traces of poisoning or damage to the body that would indicate Yuri Shchekochikhin died a violent death were found,” according to the investigators’ recently released statement. They listed TEN, also known as Lyell Syndrome, as the condition that killed the journalist.

TEN is the most severe form of Stevens Johnson Syndrome, or SJS. It is most often caused by an extreme adverse reaction to common medication such as antibiotics, ibuprofen or anti-seizure medication. It presents with a rash on the skin that blisters over and peels away. Mucus membranes such as the eyes and mouth can also blister over causing serious eye complications and dehydration.

SOURCE: Stevens Johnson Syndrome › Russian investigators say journalist’s mysterious death caused by TEN

In 1996, McCawley’s then-11-month-old daughter Julie had a severe adverse reaction to seizure medication. Called Stevens Johnson Syndrome, or SJS, the condition is rare but life threatening. SJS presents with a rash on the skin that blisters over and peels away. Blisters also can form on mucus membranes such as the eyes and mouth, leading to dehydration, infection or vision problems. It caused McCawley’s young daughter to go blind.

McCawley had never heard of SJS but soon learned how more than 200 medications have been linked to SJS, such as anti-seizure medicines, ibuprofen and antibiotics. She set out to raise awareness of the condition so that other people wouldn’t suffer the way she and her daughter did.

In 1996, the Stevens Johnson Syndrome Foundation was launched. It serves as a community forum for those who have been touched by SJS and provides information on treatments and research to help those who suffer long-term side effects of SJS.

As the recipient of ABC 7’s Extreme Makeover contest, McCawley receives $5,000 and her foundation receives $5,000. McCawley says she will use the foundation money to print and distribute more fact sheets about SJS to hospitals throughout the country.

The money she receives personally has already been spent, she says. She used it to purchase a new insulin pump for her youngest daughter, Kerry, who has Brittle Type I diabetes and Celiac’s disease. It will also cover the family’s mounting medical expenses. Julie had three eye surgeries last year alone and McCawley’s husband suffers from rheumatoid arthritis and chronic obstructive pulmonary disease.

SOURCE: Stevens Johnson Syndrome › SJS Foundation founder wins Extreme Makeover contest

SJS is a rare but life-threatening condition that presents as a rash that blisters over causing the skin to peel off in sheets and leaving the body prone to infection. Sara’s mother says half of her daughter’s skin was affected. SJS also can affect the mucus membranes, causing blisters to form on the eyes and mouth, leading to serious complications such as blindness and dehydration.

Hospitalized since March 10, Sara still has a long road of recovery ahead of her. During her hospital stay she was put into a drug-induced coma and treated as if she suffered from second-degree burns, according to her mother, Dena Ensley.

Sara will be staying at her uncle’s house where there are plenty of people to keep watch over her. They will administer medication for her pain and drops to her eyes.

“She has pain in her eyes and light sensitivity,” says Dena. The blisters from SJS damaged her corneas and made her vision blurry. Her voice is also very raspy. Despite her progress, her mother says Sara has a hard time looking in the mirror.

Visitors will be kept to just close friends and family, and she will make regular visits to Grand Rapids to visit her doctor until he gives her the “all clear.”

“She’s still sleeping a lot — taking lots and lots of naps,” Dena told the newspaper. “But she’s home.”

SOURCE: Stevens Johnson Syndrome › Michigan girl released from hospital after battle with SJS

SJS is a rare but life-threatening condition that presents with a rash that blisters, causing skin to peel off in sheets. It also can affect the mucus membranes, causing blisters in the eyes and mouth. It is most often caused by a severe adverse reaction to common medication such as antibiotics and ibuprofen. Sara’s mother says she can’t recall what medication Sara may have taken that caused such a reaction.

Sara was admitted to the hospital and her mother and father kept a vigil at her bedside while doctors worked to stabilize her condition. About 50 percent of her skin peeled away, and she was put in a medically induced coma to help control pain as she recovered.

Sara beat the odds and pulled through. She is now in the pediatric unit at the hospital, out of her coma, and slowly regaining strength as her skin repairs. Her classmates have held fundraisers at school to help her family cover the mounting medical costs. To date, the school has raised more than $2,000, and more fundraisers are planned in the weeks to come.

Source:
Grand Haven Tribune

SOURCE: Stevens Johnson Syndrome › Michigan girl recovers from SJS

The procedure is highly complex, performed in two stages and requiring a team of 15 specialists from radiology, dental and eye. It is currently only performed in Singapore, India and Japan.

“We have successfully restored vision to the most severe cases of patients who had been blinded in accidents and chemical burns. Some suffered from Stevens Johnson Syndrome (SJS), while others have had multiple corneal graft failures. In all our cases, maximal visual potential has been achieved,” says Professor Donald Tan, Head of Corneal Service and Director at SNEC.

SJS is a rare but life-threatening condition in which blisters forms on the skin, mouth and eyes, causing complications such as dehydration, infection, blindness and even death. SJS is often caused by a serious adverse reaction to common medications such as ibuprofen, antibiotics and anti-seizure durgs.

In the first phase of surgery, “First, the eye is opened up and the entire inner surface of the eyelids, cornea and scar tissues are removed. We then transplant the inner mucosal lining of the cheek onto the new eye surface. Next, we remove a canine tooth and some of the adjacent bone from the patient. We shave this down, drill a hole then fit it with an artificial cornea made of a medical-grade plastic optical cylinder. After this, we implant it into the patient’s cheek to grow a new blood supply,” he says.

Two months later, “We open the cheek mucosal lining over the eye, remove the tooth-bone-cylinder from the cheek and insert this into the cornea.”

Since all the “hardware” – tissue, bone and tooth – are taken from the patient, there is no issue of rejection whatsoever. After the final surgery, light is able to enter through the plastic cylinder, and patients will be able to regain good vision, Tan says. “Over half of our patients achieve 20/20 vision, three-quarters regain at least driving vision of 20/40, and the rest have reached their best visual potential.”

SOURCE: Stevens Johnson Syndrome › New procedure restores sight to those blinded by SJS

But last March, things went terribly wrong for Hannah. She noticed rashes developing all over her body. Those rashes began to blister and become painful. They also formed in her mouth and were so debilitating she couldn’t even speak. She had to write on a pad just to communicate. The rashes were accompanied by flu-like symptoms, and had become so severe in such a short time, she was taken to the emergency room. The doctors were baffled.

Hannah was admitted to the hospital while doctors monitored her worsening condition, giving her morphine for the pain. An eye doctor was called in to examine her eyes, which by now had begun to blister as well. That’s when Hannah first learned the name of her condition – Stevens Johnson Syndrome, or SJS.

SJS is a rare but life-threatening reaction to common medication in which the skin blisters over and begins peeling off in sheets. The eyes, mouth and other mucus membranes can blister over as well causing serious problems such as dehydration, infection and even death. Trileptal, which is also used to treat seizures, is one of several medications that can cause the serious reaction known as SJS. Other common medications linked to the condition include antibiotics and anti-inflammatory drugs such as ibuprofen.

Hannah spent three weeks in the hospital and gradually recovered. She attends high school, rides horses and enjoys the life of any 16-year-old. While she has overcome her battle with SJS, she still has lingering conditions to deal with. SJS has made focusing with her eyes difficult and painful. She recently got glasses to help with the condition. She also has to be careful what medications she takes because some medications may trigger SJS again. But she isn’t letting the problems keep her from doing “you know, normal high school teenager stuff.”

SOURCE: Stevens Johnson Syndrome › Hannah doing much better a year after battling SJS

The shot was administered to students at several schools in the West Java Province as part of the government’s national immunization program. No other children reported having severe problems, but shortly after receiving the vaccine, the young Syadiah came down with a fever and began complaining of joint pain. A health care provider gave her paracetamol syrup and an “unknown powdered medicine.” But the little girl’s health continued to fail. She started developing rashes over her body and blisters broke out on her skin, lips, tongue and gums. She was admitted to the hospital and diagnosed with SJS.

SJS is a severe adverse reaction to medication that affects about one in a million people each year. There are as many as 200 medications linked to SJS, most commonly antibiotics, anti-inflammatory medicines such as ibuprofen, anti-viral medications such as those for HIV/AIDS, and anti-seizure medicines. As the condition progresses, skin can peel off leaving the body susceptible to infection and possibly even death.

A health official in Depok debunked the notion that medical malpractice is to blame for the girl’s SJS. He is concerned that media coverage of the adverse reaction may scare people from having their children immunized.

“The media’s focus on the wrong reasons behind [Syadiah’s] condition could put the nation in greater danger,” he said.

SOURCE: Stevens Johnson Syndrome › Girl suffers SJS after receiving tetanus shot

SJS and TEN are severe adverse reactions to medication that first express as rashes on the skin. The rashes blister over causing the skin to peel away. Mucus membranes in the eyes, mouth and nose also can be affected and cause serious complications such as dehydration, infection and even death. Serious ocular complications may include permanent vision loss from corneal scaring or vascularization.

The study involved 159 patients over an 8-year period who had been diagnosed with SJS and TEN. Seventy-four percent of the group had acute ocular involvement. Patients with TEN had more frequent but not more severe acute ocular involvement. Sixty-three percent had late ocular complications, with dry eye being the most common complication.

The researchers determined that the severity of the acute ocular disease was found to be the only significant predictor of late complications. The authors suggest that all patients with SJS or TEN undergo initial ophthalmologic screening and follow-up during the acute phase of the disease and that prospective follow-up for up to a year may be necessary.

SOURCE: Stevens Johnson Syndrome › Study focuses on eye complications from SJS/TEN

But Thi is a fighter. Despite his failing eyesight, he entered Da Nang University of Technology and got a part time job to pay for his schooling. His eyesight continued to worsen and he received four surgeries on his eyes in Hanoi, Ho Chi Minh City and Da Nang. The surgeries cost so much his family couldn’t afford to even stay with Thi at the hospital. And as much as he tried to study, with 1/10 vision and recovering from surgery to improve his eyesight, he simply couldn’t keep up. He had to repeat a year of school. Doctors told Thi he would likely go blind.

There is one more hope – a surgery at Da Nang hospital in Singapore. The cost translates to about US $24,000. And that is simply out of Thi’s reach. Yet, Thi is determined to overcome his condition and graduate from Da Nang University and, with luck, have his eyesight restored.

Thi’s story is told in the Thanhniem News, one of the most widely circulated daily newspapers in Vietnam with a readership of more than 2 million per week. The newspaper raises money from readers to support a social service campaign to those in need.

SOURCE: Stevens Johnson Syndrome › SJS damaged Vietnamese man’s eyes, but he hopes to see again

SJS and TEN are serious reactions to medication that present with a rash on the skin that blisters over causing the skin to keep off in sheets. Mucus membranes such as those on the eyes and in the mouth also can blister, leading to life-threatening complications. If signs and symptoms are not quickly recognized and the medication causing the problem not identified and stopped, the reactions can be fatal.

SAEC is a nonprofit organization made up of major pharmaceutical companies and academic institutions focused on research relating to the genetics of drug-induced serious adverse events. Organized 16 months ago, the group’s mission is to develop genetic tests that can identify which patients are more likely to suffer severe adverse reactions to medication. Much of the group’s focus is on SJS/TEN.

The group’s findings were derived by pooling serious skin rash cases and control samples from GlaxoSmithKline plc London, U.K. From that data, researchers identified numerous genetic associations that may increase one’s chances of having a serious skin reaction to medication.

“This consortium has taken a significant step forward by promoting open sharing of drug safety data. This type of cooperation has the potential to lead to more personalized approaches to medicine that can reduce a patient’s risk for experiencing an adverse drug event,” said Janet Woodcock, M.D., director, the FDA’s Center for Drug Evaluation and Research.

The group’s initial research results will be published later this year.

SOURCE: Stevens Johnson Syndrome › SAEC releases first data on serious adverse events caused by drugs

Intelence is a tablet available only by prescription. It is a type of anti-HIV medicine called a non-nucleoside reverse transcriptase inhibitor (NNRTI), also known as a non-nuke. It is used to control HIV infection in adults and must be used in conjunction with other HIV medications. Intelence is for patients who have previously received treatment for HIV-1 and showed resistance to NNRTIs and protease inhibitors.

The clinical trials revealed that Intelence does carry a slight risk for serious skin reactions such as Stevens Johnson Syndrome (SJS), hypersensitivity reaction and erythema multiforme.

More than 200 medications have been linked to SJS and its more severe form, toxic epidermal necrolysis (TEN), most commonly ibuprofen, antibiotics and anti-seizure medications. SJS and TEN are severe expressions of a simple rash known as erythema multiforme. As the condition worsens, the rashes blister over causing the skin to peel off. Mucus membranes, such as the mouth and eyes, can blister over causing dehydration, infection, blindness and even death.

Patients taking medication, including Intelence, should be aware of the potential life-threatening risk of SJS/TEN

SOURCE: Stevens Johnson Syndrome › HIV treatment linked to slight risk of SJS/TEN

Late last December Ryan was diagnosed with pneumonia and days later he suffered a severe adverse reaction to the medication he was given to treat his illness. A rash formed over his body and his skin began to blister and peel away. Blisters also formed in his eyes and mouth, making his eyes and throat swell shut and leaving him unable to eat or drink. He stayed in the hospital for 12 days while doctors worked to save his life.

SJS is a rare but serious reaction to medication. More than 200 drugs have been linked to the condition, most commonly ibuprofen, antibiotics and anti-seizure medication. Some pharmaceutical companies are facing lawsuits from families affected by SJS, claiming they were not sufficiently warned of the possible life-threatening condition caused by the medications they or their family members were given. SJS, and its most severe form, toxic epidermal necrolysis (TEN), has a reported incidence of about one case per million people each year.

Ryan returned home from the hospital on Jan. 12. Though he was 28 pounds lighter and was extremely exhausted, he vowed to return to his wresting team. Last week he played in the tournament. Though he didn’t win, he says “I’m so glad to be back out there.”

SOURCE: Stevens Johnson Syndrome › High school wrestler’s fight against SJS heroic

The disease is a contagious respiratory illness. Symptoms usually start suddenly and may include a high fever, headache, tiredness, cough, sore throat, runny or stuffy nose, body aches and diarrhea and vomiting.

One way doctors help patients treat and prevent the flu is with TAMIFLU. Roache Laboratories, the company that makes TAMIFLU, says it is the No. 1 doctor-prescribed flu medication for the treatment of the flu for patients who have been symptomatic for no more than two days.

The medication is approved for both adults and children aged 1 year and older. But according to its safety labeling, and an announcement by the U.S. Chamber of Commerce, during post-marketing rare cases of Stevens Johnson Syndrome (SYS) and toxic epidermal necrolysis (TEN) have been reported by patients using TAMIFLU.

SJS and TEN are serious adverse reactions to medication. There are more than 200 types of medications that have been linked to SJS/TEN, most commonly ibuprofen, antibiotics and anti-seizure medication. The reaction begins with a rash on the skin that blisters over and causes the skin to peel off in sheets. Mucus membranes, such as the eyes and mouth, can blister over leading to serious health concerns such as dehydration, infection, blindness and even death. TEN is the most severe form of SJS, and carries a fatality risk of up to 30-40 percent.

Patients who experience a severe adverse reaction to medication they are taking are encouraged to contact their healthcare provider immediately or go to the emergency room.

SOURCE: Stevens Johnson Syndrome › TAMIFLU carries risk of serious adverse reaction

Ethyol is a prescription medication given by injection before postoperative radiation treatment sessions for head and neck cancer to lower the rate of moderate to severe dry mouth, also known as xerostomia. It is often prescribed when radiation includes the parotid glands, or the largest of the salivary glands.

The changes to contraindications and warnings for Ethyol include a warning of cutaneous reactions including erythema multiforme, SJS, TEN, toxoderma and exfoliative dermatitis. The reactions have been reported most frequently when Ethyol is used to protect against the effects of radiation. According to the new safety labeling information, some of the cutaneous reactions have been fatal or have required hospitalization and/or discontinuance of therapy.

Patients receiving injections of Ethyol should be carefully monitored as serious cutaneous reactions may develop weeks after initial use, according to the revised labeling.

The new labeling changes were approved by the FDA Center for Drug Evaluation and Research last November.

SOURCE: Stevens Johnson Syndrome › Ethyol now linked to SJS, TEN

TEN is the most severe form of Stevens Johnson Syndrome (SJS), a life-threatening hypersensitivity disorder that presents with a rash on the skin that then blisters over, causing the skin to fall off in sheets. SJS/TEN also affects the mucus membranes causing blisters in the mouth and on the eyes. The fatality rate of those with TEN approaches 40 percent.

Though she miraculously recovered, Judy was told that by doctors she would likely have lingering eye problems from the severe scaring. She learned to live with the minimal eye pain, but as each of her three children were born, her immune system seemed to go into overdrive, according to doctors, attacking the cells in her eyes and deteriorating her vision. According to her story in Frederick News Post, as the years progressed, Judy’s eyesight became worse and worse until she could no longer see the faces of her children.

Doctor’s treated Judy’s chronically dry, burning and painful eyes with steroids, but she was still unable to see very well and had become unable to tolerate light or wind. Judy sought the help of specialists, tried immunosuppressant drugs and even chemotherapy, but nothing seemed to help. Doctors advised she learn Braille and get a seeing eye dog, as it was likely her vision would only get worse.

And then Judy met with specialists at the Cincinnati Eye Institute and underwent a stem-cell transplant. It restored her vision only minimally, but doctors and Judy didn’t give up hope. Several surgeries to repair a ruptured cornea and remove cataracts finally resulted in restored vision in one eye. For the first time ever, she was able to see your youngest daughter’s face.

While more surgeries are anticipated on her other eye, and there are no guarantees her vision won’t deteriorate again, Judy says she is thankful for the vision she does have and vows to maintain a positive outlook on the future.

SOURCE: Stevens Johnson Syndrome › Woman’s sight restored after TEN

I thought that comment was odd. But a week later, my sinus infection had not improved. I took the prescription to my pharmacist. I told him that my doctor had told me to only fill the prescription if I felt I really needed it. I asked if there was any reason I should not take the med, given that I simply was not getting over my ailment. The pharmacist nodded and said Ketek was a powerful antibiotic and had some strong side effects. But if a week had passed since seeing my doctor and I was not on the mend, perhaps I should fill it.

I’m not one to react adversely to medicine. And I can usually ride out minor side effects, believing that if it has been prescribed for me, it’s working some sort of miracle. I started the drug and almost immediately after taking the medication I felt even sicker than before, with dizziness, headaches and an overall feverish feeling. I took a second dose the next day and the miserable symptoms returned. I realized then that it must be the Ketek and stopped taking it.

You may remember me telling you about Kim Oakes. She’s the remarkable woman who survived a painful battle with toxic epidermal necrolysis (TEN), the most severe form of Stevens Johnson Syndrome (SJS). SJS/TEN is a severe adverse reaction to medication in which the skin blisters and peels away. The eyes, mouth and other mucus membranes can also blister over causing serious complications and even death.

More than 200 drugs have been linked to SJS/TEN. Kim’s reaction was caused by a common antibiotic called Clavulin. She said she knew immediately after taking the first dose of Clavulin that something was wrong. The medication made her feel worse, not better.

The same happened with Hannah, the 14-year-old who had a serious bout with SJS that was linked to her bipolar medication trileptal. Hannah said the medication had made her physically ill for weeks before she broke out in painful rashes and blisters. She just didn’t realize it was the trileptal that was making her so ill.

Since writing about SJS, I have learned about the many medications that can cause SJS/TEN. And yes, Ketek is on the list. There have been publicized reports of SJS/TEN related to the antibiotic. Since my trial with Ketek, I have told my doctors not to prescribe it to me.

So, just a word of warning during these days when colds and flu are on the rise. Be aware of the medicines you are prescribed. Read up on the side effects and adverse reactions. And stay safe.

SOURCE: Stevens Johnson Syndrome › Beware of side effects from meds this season

Ralph was rushed to Miami Valley Hospital in Dayton and was diagnosed with toxic epidermal necrolysis, or TEN. TEN is a severe form of the hypersensitivity disorder known as Stevens Johnson Syndrome, or SJS. The condition occurs as a severe reaction to medication and presents as a rash that blisters over, causing the skin to peel off in sheets. Mucus membranes such as those on the eyes and in the mouth also can blister over. Complications include infection, dehydration, blindness and even death.

Phenytoin, made by Mylan Pharmaceuticals and sold under the name Dilantin, was listed as the culprit.

Ralph never recovered. He died on May 27, 2006, from TEN. Amy has since filed a lawsuit against the Mylan Pharmaceuticals and Mylan Inc., on behalf of the estate of her late husband Ralph. Amy says her husband would not have taken the drug had he known of the potential for serious side effects.

The 10-count lawsuit claims the drug maker repeaed huge profits while concealing from the public the dangers of taking Dilatin/Phenytoin. The lawsuit seeks punitive and compensatory damages for Ralph’s injuries, pain and suffering. It also seeks damages to Ralph’s estate.

SOURCE: Stevens Johnson Syndrome › Wife files lawsuit against drug maker

The latest supermarket to jump on the free antibiotics bandwagon is Genuardi’s in Montgomery County, and the public is all ears. The supermarket says it is giving away the nine antibiotics that are most common and frequently prescribed during the winter months. To get the free drugs at Genuardi’s, customers just need a prescription and a Genuardi’s pharmacy card.

And customers are hunger for the free meds, calling their doctors and pharmacies and asking for them.

Antibiotics are prescribed by doctors to treat infection. The meds do not treat viruses, the most common ailment during winter months. Some health experts fear that overuse of antibiotics has made people more resistant to antibiotics, making it more difficult for them to be successfully treated.

But there are other, more serious risks to antibiotics, says one local doctor. “For the occasional patient who gets a serious side effect, it can be life threatening,” says Dr. Thomas Fekete, an infectious disease specialist at Temple University Hospital.

One serious side effect that can occur while taking antibiotics is Stevens Johnson Syndrome, or SJS. SJS is a severe adverse reaction to medication that presents as a rash on the skin that blisters over and causes the skin to peel off in sheets. The mucus membranes also can be involved, causing blisters on the eyes and mouth. Infection, dehydration, blindness and death can occur.

Genuardi’s management says it did consider all angles of the free antibiotics offer, but decided to leave their trust in the doctors.

SOURCE: Stevens Johnson Syndrome › Caution advised with free antibiotics offer

“I was scared because first I couldn’t talk (because of the blisters in her mouth) and now I was in the hospital not even knowing what was going on,” she said. Among the physicians who examined her was an eye doctor, who knew immediately what she had. He said one of his employees had had the same thing a month earlier. He said, “She has Stevens Johnson Syndrome (SJS),” he said. Hannah quickly wrote down, “What the heck is that?”

“No one could really explain it to me,” she said. “They were taking blood and giving me morphine and drugging me up and they didn’t even know what had made me so sick.”

By the time Hannah was able to go home three weeks later, she learned what caused her SJS – it was a severe adverse reaction to her bipolar medication, trileptal.

Trileptal, also approved for the treatment of epilepsy, recently amended its safety labeling to include a warning of the risk of SJS and its more severe form, toxic epidermal necrolysis (TEN). SJS and TEN are hypersensitivity disorders that begin as a rash that blisters over and causes the skin to peel away. Mucus membranes also can be affected with blisters causing dehydration, infection, blindness and even death.

It has been almost a year since Hannah became ill. She has recovered but the memory of SJS still lingers in her mind. Her skin is almost completely healed, but now she must avoid the many medications that have been associated with SJS and TEN for fear of a relapse. “I can’t take Midol or Advil anymore,” she said. “Now, my mom tells me what to take.”

SOURCE: Stevens Johnson Syndrome › Teenager shares story of serious reaction to medication

Darunavir, manufactured by Tibotec, belongs to a class of anti-HIV drugs called protease inhibitors (PI). It works to prevent cells infected by HIV from producing new virus, thus reducing the amount of virus in the body. Darunavir must be coadministered with 100-mg ritonavir and with other antiretroviral agents. It was approved by the FDA in June 2006 for HIV-positive adults who were treatment-experienced.

Last October, darunavir was approved for HIV-positive individuals beginning treatment. The medication has proven effective for patients who are not likely to respond to older PIs and for those who are starting antiretroviral therapy for the first time.

SJS and its more severe form, toxic epidermal necrolysis (TEN), are serious adverse reactions to medication. The reaction begins with a rash that blisters over, causing the skin to peel off in sheets. Mucus membranes in the eyes and mouth also can blister over, leading to dehydration, infection, blindness, and even death. More than 200 medications have been linked to SJS and TEN, including NSAIDs such as ibuprofen, antibiotics and anti-seizure medication.

Other warning included in the labeling revisions for darunavir include warnings of potential drug-drug interactions and pregnancy risk. Darunavir should not be taken with dihydroergotamine, ergonovine, ergotamine, methylergonovine, cisapride, pimozide, oral midazolam, triazolam, St. John’s Wort, lovastatin, simvastatin, or rifampin.

Darunavir also should be taken during pregnancy only if the potential benefit justifies the potential risk, according to the report. Mothers on darunavir should not breast feed, and children younger than 3 should not take darunavir.

SOURCE: Stevens Johnson Syndrome › HIV medication carries warning of SJS

SJS and TEN are hypersensitivity disorders that affect the skin and mucus membranes. It begins as a rash that blisters over, causing the skin to peel off in sheets. The mouth, eyes and other orifices can be affected with blisters as well. The condition can be life-threatening.

Oxcarbazepine is relatively new anti-seizure treatment for epilepsy. It works by blocking the channels that electrical signals use to get into brain cells. According to the update, individuals treated with oxcarbazepine who experienced the reactions had a fever and a rash. Some patients had enlarged lymph nodes and some experienced symptoms such as itchiness and joint pain. The rash usually appeared within three weeks of starting treatment with oxcarbazepine.

More than 200 medications have been linked to SJS and TEN. Many anti-seizure medications have been associated with the severe reactions. Those on oxcarbazepine or any other treatment for epilepsy should contact their doctors immediately if they experience any of the warning signs of SJS or TEN, including raised lumps, flaky skin, swollen face, painful skin, purple blotches, sores on the lips or inside the mouth, or any asthma symptoms such as wheezing and difficulty breathing.

SOURCE: Stevens Johnson Syndrome › Oxcarbazepine/Trileptal epilepsy meds linked to SJS/TEN

Joe was just 4 years old when he died. He contracted meningitis at one week old and eventually was diagnosed with Angelmans Syndrome, a neuro-genetic disorder that can cause developmental delays, seizures and jerky movements. Those with Angelmans Syndrome appear to have a happy, joyful demeanor. Shortly after the diagnosis, Joe was put on Topiramate, an anticonvulsant to control his seizures. But the medication caused a severe adverse reaction called Stevens Johnson Syndrome (SJS).

“We were warned about the usual side effects – loss of appetite, liver problems, etc., but not SJS,” his family writes in the online journal, Joe Way Inspired.

SJS damaged Joe’s organs and left him vulnerable to numerous infections. His body was frail, but his spirit was strong. His family focused on giving Joe the opportunity to live his short life to its fullest, taking him to the beach and letting him play in the water. Last May, he lost his fight.

Four weeks after Joe died, his family launched the Web site memorial. Its focus is to raise money for a children’s hospice in their town of Cornwall.

Last week, Joe’s family launched a series of videos on YouTube. The videos show the spirit of little Joe and the fund raising efforts of others. The Way family alone has raised more than £28,500 as part of the “children’s hospice South west Precious lives appeal.” Others have helped raise funds as well, making the hospice, which will be named Little Harbour, a reality.

Joe won’t be able to reap the benefits of Little Harbour, but his family has seen the plans for the facility. As Joe’s father said in one video, speaking to a church congregation, “Still, in his own way, he is inspiring people even though he is not here.

SOURCE: Stevens Johnson Syndrome › SJS victim’s family helps raise funds for children’s hospice

GIST are rare tumors that usually appear in the stomach or small intestine. They tend to be resistant to chemotherapy, and are considered aggressive cancers. Re-occurrences of GIST tumors tend to be more aggressive and are associated with lower survival rates.

The new treatment, Glivec, is the only post-surgery treatment that has been shown to delay the return of this deadly cancer. In studies conducted, Glivec was proven effective in more than 9 out of 10 patients who received the medication based on a 14-month follow up. Data sponsored by National Cancer Institute showed that 91.6 percent of patients on Glivec therapy remained cancer-free after a 14-month follow up compared to 80.2 percent of patients who took a placebo.

Glivec also is approved for the treatment of Philadelphia chromosome-positive myeloid leukemia, Kit-positive gastrointestinal stomal tumors which cannot be surgically removed or have metastasized, and other rare diseases. Regulatory reviews are currently underway in the European Union and Switzerland.

SJS has been listed as a rare adverse reaction to Glivec. SJS is a rare but life-threatening reaction to medication. It begins with a rash on the skin that blisters over, causing the skin to peel away in sheets. Blisters can also form on the eyes and mouth, leading to dehydration, infections and serious eye problems. The condition can be fatal.

SOURCE: Stevens Johnson Syndrome › Glivec proven effective in treatment of GIST, but linked to SJS

The study is the largest conducted to-date focusing on Latino patients with the hepatitis C virus. The virus is a blood-borne infectious disease of the liver that can lead to cirrhosis, liver cancer and the need for liver transplants. Hepatitis C is reported to affect Latino patients differently than non-Latino patients. The Latino population is the largest-growing minority in the United States and has a higher prevalence of hepatitis C. The virus also has a faster progression and a much higher mortality among Latinos than non-Latinos.

PEGASYS is produced by New Jersey-based Hoffman-La Roche Inc. It can be used alone or in combination with COPEGUS, for the treatment of adults with chronic hepatitis C who have compensated liver disease. The medication was found most effective in patients with compensated liver disease and histological evidence of cirrhosis.

However, erythema multiforme major, also known as SJS, was reported among the serious adverse events that occurred during post-approval use of PEGASYS therapy. SJS is a rare but life-threatening reaction to medication that begins as a rash that blisters over, causing the skin to peel off in sheets. It also affects the mucus membranes, such as eyes, mouth and vagina, which can blister over and lead to dehydration, infection and serious eye problems such as blindness. More than 200 medications have been linked to SJS.

If you experience a rash or blistering while taking PEGASYS or any other medication, healthcare officials advise you contact your doctor and go to the emergency room.

SOURCE: Stevens Johnson Syndrome › Hepatitis C treatment proven effective but linked to SJS

One such resource is an online survey designed to develop an international SJS/TEN registry with the goal of lobbying the federal government for a mandatory reporting system of all adverse drug reactions. You can help the Foundation reach this goal by filling out the survey.

Another valuable tool is the direct link to the FDA’s MedWatch: Reporting by Consumers link that easily enables consumers to report any serious reactions to drugs and medical devises. While individuals are encouraged to report these reactions to their health care provider so that the information can be evaluated based on your medical records, that step is not required. Consumers can simply complete the online form and report the incident directly to the FDA.

SJS/TEN is a rare but life-threatening hypersensitivity condition most often caused by common medication, including ibuprofen, antibiotics and anti-seizure drugs. It affects the skin and mucus membranes marked by a rash on the skin that blisters over and peels away in sheets. The mouth, eyes and other orifices can be affected causing dehydration, infection and serious eye problems such as blindness.

SOURCE: Stevens Johnson Syndrome › SJS support site offers valuable resources to those affected

In a recent post on her blog, Sight for Sore Eyes SJS, the mother of a boy who had been diagnosed with toxic epidermal necrolysis (TEN), the most severe form of Stevens Johnson Syndrome (SJS), ranted about the updates to over-the-counter medications to kids. The warnings, she said, were nondescript and did not adequately portray the dangers that could occur when taking the medication, like the reaction her son had when he was just 3. For Helen, a more reasonable warning label would read: “If your child survives the most agonizing drug reaction, they will live with intense pain and vision loss for the rest of their lives.”

Helen would know. Ian was 3 years old when he was diagnosed in 2001 with TEN. Ninety percent of his skin peeled away and his lungs and digestive track burned and his eyes blistered. He hung on the edge of life before slowly and miraculously recovering. His skin gradually healed but his eyes were adversely affected. He suffered extreme pain and blindness.

Since his diagnosis, Helen has done everything in her power to give Ian a healthy life, from moving across country to seeking out medical treatment to help him see again. Her blog is a regular testament to her dedication to raise awareness of the ill affects of some common medications so others don’t suffer the way Ian has. Keep up the great work, Helen!

SOURCE: Stevens Johnson Syndrome › Mother offers sight for sore eyes

Researchers like Wen-Hung are asking why.

SJS is a life-threatening hypersensitivity condition that causes rashes to form over the body. The rashes blister over, causing the skin to peel off in sheets. SJS also can affect the mucus membranes, causing blisters to form in the mouth and eyes. Death can result in about 10 percent of patients with SJS. If it progresses to its most severe form, toxic epidermal necrolysis, (TEN) the death rate soars to 40 to 50 percent. SJS/TEN is linked to more than 200 medications, most commonly ibuprofen, antibiotics and anti-seizure medication.

A group of Chang Gung researchers were aware that the anticonvulsant carbamazepine was linked to many cases of SJS, but through its own study using Taiwanese patients, researchers discovered a possible connection – “a high correlation between hypersensitivity to carbamazepine and a single allele, human leukocyte antigen B1502,” according to the report. As many as 80 percent of Taiwanese carry the allele. The discovery lead to an FDA warning in the U.S. of the increased risk of SJS/TEN for patients of Asian ancestry with the B1502 allele who take carbamazepine.

Since the discovery, researchers began focusing on developing a test to determine whether a patient has the B1502 allele, and lead researcher Wen-Hung turned his attention on a treatment to halt the progression of SJS/TEN.

SOURCE: Stevens Johnson Syndrome › Taiwanese researchers pinpoint genetic marker for SJS

The latest drug to make this list is bendamustine, marketed under the names Teanda in the U.S. and Ribomustin. Bendamustine was first approved by the FDA for treatment of CLL in March 2008 and for NHL in October 2008. It is the first drug approved to treat CLL since 2001.

According to the report, one case of TEN was reported following the use of bendamustine in combination with rituximab, a chimeric monoclonal antibody. TEN has been previously reported for rituxima. Bendamustine’s relationship to TEN has not been fully determined. The label urges healthcare providers: “Where skin reactions occur, they may be progressive and increase in severity with further treatment. If skin reactions are severe or progressive, Treanda should be withheld or discontinued.”

SOURCE: Stevens Johnson Syndrome › New labeling for CLL, NHL drug includes TEN warning

Currently, the SAEC is conducting a study that addresses Stevens Johnson Syndrome (SJS). SJS is a rare but life-threatening reaction to medication. SJS affects the skin and mucus membranes, causing blisters to form on the skin and the skin to peel off in sheets. Blisters also can form on the mouth and eyes, causing serious eye complications and even blindness. SJS is linked to more than 200 medicines. Most often SJS is linked to ibuprofen, antibiotics and anti-seizure medication.

Researchers for the SAEC project will look for genetic variations linked with SAEs from the SNP Consortium and the Human Genome Project’s Hap Map Project.

“The traditional research model only provides one piece of the puzzle in understanding the genetic variations that could lead to an increased risk of an adverse event. Because of the number of patients needed to tie a genetic variant to an SAE, and the resulting cost of doing these studies, no one company, research center, or agency can efficiently conduct this research on its own. The most efficient way to study drug-related SAEs is to create a global, publicly available ‘knowledge base’ that will help identify the genetic variations that may predict SAEs,” SAEC Chairman and CEO Arthur Holden said in a September 2007 announcement in Highlight Health, when the consortium was formed.

The SAEC research study will be made available within 12 months of completion. If initial studies are successful, the consortium vows to study every major SAE to find its genetic cause.

SOURCE: Stevens Johnson Syndrome › Consortium studies genetic markers, hopes to predict SJS

Health Canada recently updated its report of adverse reactions to some of the more common herbal products, including Echinacea, ginko and St. John’s Wort. According to the report, some people have reported experiencing rashes after taking St. John’s Wort. St. John’s Wort is an herbal treatment for major depression and is available over the counter in the U.S.

Ginseng is another common herb readily available in the U.S. Ginseng is a stimulant taken orally to treat type II diabetes and sexual dysfunction in men. Ginseng also can be found in some popular energy drinks and foods. Studies show that ginseng has been linked to at least one occurrence of Stevens Johnson Syndrome (SJS), a severe adverse reaction to medication.

SJS usually begins with a fever and sore throat and progresses to rashes that cover the skin and mucous membranes. As the condition progresses, the rashes can blister over and cause the skin to fall off in sheets. The mouth and eyes also can blister, which can lead to dehydration, infection and serious eye problems and even blindness.

The International Journal of Pediatric Dentistry also reports that a 10-year-old Indian boy developed severe mouth and eye ulcers and was subsequently diagnosed with SJS after taking an “herbal medication of plant origin” prescribed by a traditional healer for treatment of a fever. According to the book, traditional therapy with herbal preparation (Ayurvedic medicine) is not uncommon in India.

Doctors advise those who experience symptoms of SJS to go immediately to the emergency room.

SOURCE: Stevens Johnson Syndrome › Herbal remedies may cause severe adverse reactions

Modafinil (Provigil) is approved by the FDA to treat narcolepsy and excessive daytime sleepiness associated with obstructive sleep apnea. Modafinil (Provigil) also has been shown effective in the treatment of depression, cocaine addition, Parkinson’s Disease and schizophrenia, though the FDA has not approved the drug for those conditions. It also was thought to be an effective treatment for Attention-Deficit Hyperactivity Disorder (ADHD), however in 2006 it was rejected by the FDA for use by children for ADHD. Cephalon now discourages the drug’s use in children for any purpose.

Since December 1998, when Modafini (Provigil) was introduced to the market until January 30, 2007, seven cases of seven cases of severe cutaneous adverse reactions to the medicine were reported to the FDA. Those cases included SJS and its more severe form, toxic epidermal necrolysis (TEN).

SJS and TEN has a reported incidence rate of about one case per million people each year. It is most often caused by an adverse reaction to medication. Medications that have been linked to SJS and TEN include NSAIDS (non-steroidal anti-inflamatory agents), anti-seizure medications and some antibiotics.

SOURCE: Stevens Johnson Syndrome › Stimulant drug added to list of meds that can cause SJS/TEN

Beatham’s girlfriend of two years, Louise Armstrong, came down with flu-like symptoms in late December. The morning of New Year’s Eve, Beatham woke in their Penrith, Australia, home to find his partner gravely ill with blisters covering her body. He called the ambulance, but it was too late. Armstrong had died.

According to the News & Star, Beatham was made to wear a paper body suit while detectives waited to hear word from the pathologist on the cause of death. The pathologist determined the cause was natural, and that she had died from a rare but severe adverse reaction to medication called Stevens Johnson Syndrome, or SJS.

SJS, and its most severe form, toxic epidermal necrolysis, or TEN, has a reported incidence of about one case per million people each year. It affects people of all ages, including young children, and is most often caused by common medication such as ibuprofen, antibiotics and anti-seizure medication, to name a few. Defined as a hypersensitivity disorder, SJS/TEN affects the skin and mucous membranes, causing the skin to blister and peel away in sheets. Blisters also can form in the mouth or eyes, and can lead to severe eye problems or blindness.

Armstrong’s parents, Ted and Angie, were distraught about their daughter’s death and puzzled why police would think their daughter’s boyfriend was to blame. At the time of their daughter’s death, they were dealing with the sudden serious illness of their son, Chris, who as hospitalized at the time with epilepsy.

“It hasn’t yet hit us fully,” Mrs. Armstrong said of her daughter’s death.

SOURCE: Stevens Johnson Syndrome › Australian woman dies from adverse reaction to medication

Kim had suffered a severe adverse reaction to a common antibiotic she received after being bitten by a feral cat. She was diagnosed with toxic epidermal necrolysis (TEN), the most severe form of Stevens Johnson Syndrome (SJS).

“I knew something was wrong when I started taking the antibiotic,” Kim says. “I felt different immediately.” She had taken other antibiotics before and never had any problems. But this drug made her ill. Just days after beginning the antibiotic, she stopped the medication. But then her fever spiked and her head began pounding. Her body broke out in a rash.

Her condition continued to deteriorate. Kim was admitted to the hospital and received morphine for the pain. The doctors and nurses were baffled. It wasn’t until a wound specialist checked her that she was finally diagnosed with SJS/TEN.

Once diagnosed, doctors were able to treat her, but the struggle was only beginning. Kim was put into a drug-induced coma for 15 days. She remembers strange dreams, like wanting to fall into a deep sleep but her sister, Lisa, kept throwing pixie dust on her, keeping her from drifting off. “She may have saved my life,” she says with a laugh.

Kim was determined to overcome SJS/TEN, and miraculously, was able to go home before Christmas. She spent the day with her children. “I was just so glad to be home,” she says.

Kim began physiotherapy last week – impressing her physiologist with her strength and range of motion. Movement is hard, she says, because the new skin is taut and hurts when stretched. She knows recovery is a long road, but she looks forward to going back to work as an animal control officer.

“It’s been a wild ride,” she says. “I’m glad that part is over.”

SOURCE: Stevens Johnson Syndrome › Kim continues to recover from dangerous bout with TEN

Rachel was looking for others like her – people who had taken common medication, like ibuprofen from the super market, and had a severe adverse reaction called Stevens Johnson Syndrome (SJS) or its most severe form toxic epidermal necrolysis (TEN).

She shared her struggle in the videos and in an interview with me – how her skin blistered and peeled off in sheets, how sores blossomed on and in her mouth and her eyes became bloodshot. “Dracula eyes,” she called it. It was her gynecologist – who also serves as her primary care physician – who diagnosed her with SJS. He sent her immediately to the emergency room.

“They (emergency room staff) kept asking me, ‘What did you take? What did you take?’ and I kept saying, ‘nothing,’” she says, because the last medication she had taken – the ibuprofen for a headache – was two weeks earlier.

The next few days were a blur. Rachel was admitted to the hospital on a Friday, and by Sunday doctors were putting her into a drug-induced coma to shield her from the pain and heal her battered body. Ninety-seven percent of her skin had peeled away. She stayed in the coma for six weeks. What she remembers of that time are vivid dreams and nightmares. Rachel’s recovery was slow and arduous. The videos, it seems, were a way for her to cope, to fully understand the battle she had fought. Some don’t win that battle. Knowing that, she says, both frightens and humbles her.

Nearly five months after she fell ill, Rachel’s life is beginning to return to normal. She celebrated Christmas with her family. “I almost wasn’t here on Christmas,” she says. Last week she returned to her job full time. She is no longer in rehab. (She stopped a week and a half early, she says, because insurance stopped paying.) “My wounds have healed,” she says, though the condition has caused macular degeneration. “I may lose my eyesight.” She’ll have to follow a rigorous eye hydration regime to keep her eyes as healthy as possible.

Most importantly, as she heals, Rachel is trying not to clutter her mind with negative thoughts – like, what if the condition returns. “I hear this is normal – for me to feel this way,” she says.

Rachel’s desire is to develop a community on YouTube for people affected by SJS and TEN. If you or a member of your family has been touched by SJS or TEN, Rachel encourages you to contact her through her YouTube channel.

SOURCE: Stevens Johnson Syndrome › Life slowly returns to normal for SJS survivor, SpunkyRachel

For a year Joe lived in the dark, lying in the dark of his home, unable to even see the face of his wife. That, he said, is what he most missed.

And then a miracle happened. Joe was told by his cornea specialist Dr. C. Stephen Foster a the Massachusetts Eye and Ear Infirmary about about the innovative work of Dr. Perry Rosenthal at the Boston Foundation of Sight. Dr. Rosenthal had developed a deep contact lens called a scleral lens that was literally enabling the blind to see again. The lens rests on the sturdy white of the eye, and creates a tear-filled pool over the cornea.

The scleral lenses changed Joe’s life. A couple weeks after going to the Boston Foundation for Sight, Joe was fitted for lenses and was able to see again.

Joe’s touching story is played out on a video by the Boston Foundation of Sight. “He put in the lenses and said, ‘Oh my God. I can see,’” said his wife. “It’s a miracle.”

Though Dr. Rosenthal’s lenses have changed lives, insurance companies still see them as a cosmetic device. The custom, handmade lenses cost around $5,500 per pair. Making them more readily available is a priority for the Boston Foundation of Sight and Dr. Rosenthal.

“Sight should not be a gift. It should be a birthright,” he says on the video.

SOURCE: Stevens Johnson Syndrome › Scleral lenses gives sight to man blinded by SJS

Today I read the story of Joe Way of England. He was born just two and a half months before my son, on September 5, 2003. Though an ocean apart, he was not unlike my son. He was born healthy to a loving family. But at a week old, he contracted meningitis and eventually was diagnosed with Angelmans syndrome, a neuro-genetic disorder that can cause developmental delays, seizures and jerky movements. It is so named because those who suffer from the condition appear to have a happy, joyful demeanor. In order to control the seizures, Joe was put on Topiramate, an anticonvulsant.

“We were warned about the usual side effects – loss of appetite, liver problems, etc., but not SJS (Stevens Johnson Syndrome),” his family writes in their online journal Joe Way Inspired.

Joe was taken to the hospital where doctors watched as the mysterious symptoms appeared and the little boy’s health deteriorated. He was eventually diagnosed with SJS, a rare but life-threatening adverse reaction to drugs – such as anti-seizure drugs – that causes the skin and mucus membranes (eyes, mouth, genitals) to blister and peel away in sheets.

“He had experienced bad health throughout his short life, but nothing compares to the horror of SJS,” his family writes.

Details of his story and photos of the beautiful boy are shared on the site, and are much too difficult for this mother to type. Joe did pull through, but his health was badly compromised. He was put on a home ventilation device and his health increasingly deteriorated.

Joe’s family understood that their time with their young son was limited, but they did their best to provide the best at-home care for Joe in order to limit his hospital visits. He was too sick to make it to Little Bridge House, the children’s hospice in Devon, something that deeply affected the family.

After a two-year battle, Joe’s little body finally gave out. He died May 7, 2008, just four months before his 5th birthday. Shortly after, his family published the Web site in his memory, calling for donations to fund a children’s hospice in their town of Cornwall. So far, more than 30,000 pounds has been raised for the Children’s Hospice South West center, called Little Harbour.

“Supporters pondering the plans will see a slate roof, Cornish stone walls, and a tower reminiscent of the many lighthouses surrounding the Plymouth and Cornish coastline, and designed to reinforce the hospice’s Cornwall and Plymouth connections. They will also discover the special children’s bedrooms, accommodation for parents and siblings, a wide range of play and therapy facilities – including a messy play area, a Jacuzzi, and a multi-sensory room – and a homely family kitchen and living room which are all designed to help create a comfortable and wonderfully caring community,” the site details.

Donations can be made online at www.joeway.co.uk.

“It is critical to ensure life limited children get this support in Cornwall,” writes his family.

SOURCE: Stevens Johnson Syndrome › Family raises funds for children’s hospice after son dies from SJS

Before being admitted to the hospital, Baylee was thought to be suffering from a combination of strep throat; hand, foot and mouth disease; and erythema multiforme (EM). EM is an acute, self-limiting inflammatory skin eruption. It often affects the mouth, eyes and other moist surfaces. One category of EM, known as EM major, is Stevens Johnson Syndrome (SJS). SJS often appears following fever, malaise, cough and sore throat. A skin biopsy can confirm SJS.

Unlike with SJS, there is no single test to detect KD. Doctors usually diagnose it by looking at the symptoms expressed and ruling out other conditions. Symptoms usually include a fever lasting five or more days; redness in both eyes; changes around the lips, tongue or mouth; swelling, discoloration or peeling in the fingers and toes; a rash in the trunk or genital area; large, swollen lymph node in the neck; and red or swollen palms of the ands and soles of the feet.

SJS is most often caused by an adverse reaction to medication; the cause of KD is still unknown. If left untreated, KD can cause inflammation in the coronary arteries as well as the walls of the small and medium sized arteries throughout the body. Doctors say Baylee’s arteries were affected and he received treatment, according to E! Online. Baylee was released from the hospital just days before Christmas and will be monitored carefully by pediatric cardiologists over the next 6-8 weeks.

SOURCE: Stevens Johnson Syndrome › Singer’s son diagnosed with rare disease similar to SJS

The Stevens Johnson Syndrome Foundation was founded as a community for adults and children affected by the condition. It is a 501(c)3 nonprofit organization dedicated to promoting public awareness to adverse drug reactions. Tax-deductible donations help power the organizations Web site and enable its members to raise awareness of the condition and provide much needed support to others suffering from SJS and TEN.

One of the organization’s outreach projects aims to provide comfort to the tiniest sufferers of SJS and TEN. For a tax-deductible donation of $30, the organization provides a plush bear and blanket to a child with SJS and TEN.

For more information about this important cause visit the SJS Foundation’s Donation Center. To participate in the bear & blanket program, send your $30 check payable to the Stevens Johnson Syndrome Foundation, P.O. Box 350333
 Westminster, CO 80035-0333,
 USA. Please include “SJS Kids Comfort” in the memo section. Other donation opportunities also are detailed on the Web site.

SOURCE: Stevens Johnson Syndrome › Bear and blanket program gives comfort to kids with SJS

But the blisters got worse. They spread down her throat and little Julie was unable to drink her bottle because of the pain. Jean rushed her daughter to the hospital, where doctors continued to administered the phenobarbatol for her seizures. But Julie’s health continued to decline. Four days later the little girl’s lungs collapsed and her skin began coming off in sheets. That’s when a nurse realized what was going on. “This is Stevens Johnson Syndrome (SJS),” she said. Jean was relieved to have a diagnosis, but the doctor said, “This is extremely serious. She could die.”

Jean shared her story earlier this year to Voice America’s Disability Matters radio show with host Joyce A. Bender. Jean appeared on the show with SJS survivor Elizabeth Boxer and her father Mark.

When Jean’s daughter was diagnosed with SJS, she was told the adverse reaction to medication such as anti-seizure medication, ibuprofens and antibiotics was so rare that she would probably never hear of it again. But Jean refused to believe that the illness that threatened her daughter’s life and left her blind in one eye and visually impaired in the other – a condition caused by common medications – was as rare as doctors described. She made it her mission to found a community where others touched by SJS could share their stories. Thus, the Stevens Johnson Syndrome Foundation was established.

Shortly after founding the organization, Jean discovered that several people were suffering from the disease. Many, like Jean, were looking for answers as to how medicine designed to help can actually cause more harm.

“This is wrong,” announced Jean on the radio program, where she took questions from listeners. “(SJS) is not rare. What’s rare is having it reported to the FDA.”

SOURCE: Stevens Johnson Syndrome › SJS Foundation established to give answers to those with SJS

But earlier this week, she was chosen along with several other sick children to travel to Lapland, Scotland, and visit with Santa Claus, according to The Edinburgh (Scotland) Paper, Evening News.

Each year the Edinburgh charity FACE organizes the trip to the snowy village, to Santa’s home, for children with life threatening illnesses. The guests of honor had struggled much this year and relished in the opportunity to meet face-to-face with Santa. Some of the children suffered from cancer, others from spinal cord injuries. Like Kacey, all were deeply moved to have the opportunity.

“How will I know what the elves are doing if I can’t see them?” Kacey whispered to the Edinburgh Royal Hospital for Sick Children nurse who traveled with her. “Don’t worry,” the nurse answered, “I’ll tell you.”

SJS and TEN are rare but serious conditions that most often occurs as an adverse reaction to medications such as ibuprofen, anti-seizure medications and antibiotics. It affects people of all ages and genders, including children and infants. Defined as a hypersensitivity disorder, it causes the skin to blister and peel away. Mucus membranes also can be affected, causing lesions in the mouth or eyes. When the condition affects the eyes, ocular problems can occur. These can include conjunctivitis, scarring of the conjunctiva, inflammation inside the eye (iritis), corneal blisters and perforation, which can potentially lead to permanent vision loss.

SOURCE: Stevens Johnson Syndrome › Child with TEN gets a special trip to Santa’s snowy village

Young Ian clung to life as 90 percent of his skin peeled away and his lungs and digestive tracts were burned. He beat the odds and survived, but his eyes were adversely affected. He suffered such mounting pain from ulcers and inflammation in the eyes that one Alberta physician suggested Ian’s eyes be removed to alleviate the pain. It was not an option Ian’s mother was willing to accept.

Over the past seven years, Ian has had 38 surgeries to correct his vision. Many of those years were spent in the dark. His last surgery, in October, has enabled him to see much more clearly and has restored his depth perception. Because SJS ate away the protective film over his eye, he now wears a deep contact lens to prevent his eyelid from collapsing onto his cornea.

It is a long and grueling road to recovery, but today 10-year-old Ian’s body shows few signs of SJS. His skin, treated by vitamin E capsules, has grown back, and – following doctor’s orders – he plays video games for two hours a day to exercise his eyes.

SOURCE: Stevens Johnson Syndrome › Canadian boy’s family still fighting to save eyes harmed by SJS

The eyes are especially vulnerable. Typical ocular problems associated with SJS and TEN can include conjunctivitis, scarring of the conjunctiva, inflammation inside the eye (iritis), corneal blisters and perforation, which can potentially lead to permanent vision loss. Therapy for ocular problems often includes ocular lubrication with artificial tears and ointments. Plus, individuals must be on constant watch for various ocular infections. Corneal transplants, limbal stem cell transplantations or artificial corneal procedures maybe considered if there is lasting damage.

One company is helping ease the sting of recovery for people who have had SJS and TEN and stuffer from lingering eye problems. Eyeeco, a distributor of eye hydration products, offers 15 percent discounts on its products to those who have had SJS or TEN. All users need to do is type “SJS” in the promotional code field and their discount will show up at checkout. Eyeeco’s Tranquileyes eye hydrating therapy, which includes drops and goggles, is specially designed to naturally hydrate dry, tired eyes, reduce eye puffiness and create complete darkness to enhance relaxation and sleep. Chronic Dry Eye Kits cost between $49 and $59.

SOURCE: Stevens Johnson Syndrome › Company offers discount on eye products to SJS/TEN survivors

SJS is a rare but life-threatening disorder usually caused by an adverse reaction to common medication such as antibiotics, anti-seizure medication and ibuprofen. Its most serious form is toxic epidermal necrolysis (TEN). SJS and TEN are defined as hypersensitivity disorders that affect the skin and mucous membranes. The disorder is a severe expression of a simple rash that can blister over and cause the skin to peel off. Blisters also can form on the eyes and mouth, causing  ocular problems, dehydration, infection and even death.

Rachel sounds somber in one of her first videos. She is bald and her dark skin is marked by large patches of white. She lost 97 percent of her skin and her hair. She hopes her pigment will return and her hair will grow back. But after coming out of a six-week-long, drug-induced coma and surviving the extreme pain of the disorder, she realizes she is lucky to be alive.

“This has been an absolute horror show for me,” says Rachel.

The horror began when she took ibuprofen that she had purchased from a grocery store. She became ill and soon was admitted to the hospital where she was diagnosed with TEN, the worse form of SJS. “I’ve taken ibuprofen for many years and, God, nothing like this has ever happened,” she says. Now gradually recovering, she hopes to find friendship and bonding with others through YouTube.

This later video shows an upbeat Rachel. She is sporting a wig, which she calls her “fantasy hair” – the short hairdo she always wanted but was too afraid to do. Her mother had told her that she needed to explain what the disorder is, and here she does. She tells us that she would love to form the SJS YouTube community. She would love to talk with others who have suffered the way she has, share stories about recovery and pain management.

“I really hope that I find that somebody,” she says.

SOURCE: Stevens Johnson Syndrome › Woman recovering from TEN hopes to form YouTube community

In January 1998, Santoso came down with a fever and sore eyes. He went to two different doctors and received medication for his condition, but he became increasingly sicker. “Suddenly all my skin blistered. My eyes became blind,” he says as disturbing photos of him flash on the video. Santoso was admitted to the hospital and diagnosed with Stevens Johnson Syndrome (SJS).

SJS is a rare but life-threatening condition that usually occurs from a reaction to common medications, such as antibiotics, ibuprofen or anti-seizure drugs. SJS often begins with a rash that becomes blistered and peels away. It affects the skin and mucous membranes, causing blisters to form in the mouth and eyes. The most severe form of SJS is toxic epidermal necrolysis (TEN).

During his battle with SJS, Santoso says he “humbled myself to God.” He vowed to serve God if he would healed. Three weeks later, Santoso was able to leave the hospital. Keeping his promise, Santoso became a reverend.

But Santoso still suffers from the ill effects of the disease he had a decade ago. “My eyes are very disabled,” he says. “I live with blur eyes.” He says he needs to put “tears” in his eyes every five minutes. He goes through a bottle of eye drops a day.

Yet, he is happy to be alive. “I am thankful to the Lord because he has given the healing to me,” he says. “And I hope my testimony can help you.”

SOURCE: Stevens Johnson Syndrome › Man shares SJS struggle on YouTube video

Kim experienced a rare reaction to the antibiotic that started with a headache and progressed quickly to toxic epidermal necrolysis (TEN), a severe form of Stevens Johnson Syndrome (SJS), a reaction to medication where the skin blisters and peels off. Ninety percent of the time the reaction is caused by drugs such as ibuprofen, antibiotics and anti-seizure medications.

Kim lost 70 percent of her skin and was put into a drug-induced coma. She was given a 30 percent chance of survival by one doctor. She managed to beat the odds, and was released from the hospital this week.

“Why aren’t people told that they could die if you have a reaction to this drug?” Kim’s father, Art Oake, posed to CBC News.

Nearly one in a million Canadians are treated for SJS/TEN each year. One in six die, according to the story. Toronto dermatologist Dr. Neil Shear urges patients who take antibiotics or drugs used to treat epilepsy to look for signs of adverse reactions, such as fever, tender skin and blistering or sores in the mouth. Patients who experience any reaction should stop taking the drug immediately and call their doctors, he said.

SOURCE: Stevens Johnson Syndrome › Father asks why he wasn’t warned of possible reaction to drug

“It is absolutely amazing that within three weeks of being admitted to ICU, she will be able to walk out of the hospital (with the help of a walker),” Lisa writes in a Dec. 17 update. Doctors say that Kim’s fast recovery has been staggering. One doctor told the family that when he first saw Kim when she admitted to the hospital weeks ago, he believed her chances of survival were only 30 percent.

Many who contract TEN, a more serious version of Stevens Johnson Syndrome (SJS), do not survive. SJS and TEN are rare but serious and potentially life-threatening hypersensitivity disorders that affect the skin and mucous membranes, causing the top layers of skin to peel away and the eyes and mouth to become blistered. SJS and TEN can be caused by an adverse reaction to common antibiotics and over-the-counter medications such as ibuprofen and Children’s Motrin.

Last month just before Kim was diagnosed, Elizabeth Patton, a 17-year-old girl from Brentwood, Tenn., was hospitalized with TEN. Her story ended differently. Just days after Thanksgiving, Elizabeth lost her battle to the disorder, leaving behind a family that vows to warn others about the seriousness of SJS and TEN.

According to Lisa’s updates, Kim was taken out of her drug-induced coma last week, though she remained in the hospital’s burn unit., unable to see guests. She began getting around with the help of a walker and was finally able to visit with her children. In a sense, she willed herself well, turning down morphine and working hard to recuperate, so that she could be home with her family for Christmas.

Call it a Christmas miracle, but it appears Kim’s Christmas wish is coming true.

SOURCE: Stevens Johnson Syndrome › Canadian TEN victim leaves hospital in time for Christmas

Kazuyuki Ogura of Kawasaki was a victim of a serious side effect from common over-the-counter medicines. Weeks after the 37-year-old man took cold medicine for a day, he came down with a high fever, rash and bloodshot eyes. He was diagnosed with Stevens Johnson Syndrome (SJS). Ogura survived this potentially deadly but rare reaction to medication, but it was a year and a half before he was able to return to work. His vision is still not up to par. “No one had ever told me that over-the-counter drugs carried such risks, “ he told the newspaper.

Those who oppose the restrictions – the Japan Online Drugstore Association (JODA), Rakuten and Yahoo – have petitioned the Minister of Health, Labor and Welfare to stop the proceedings. JODA and the Internet giants argue that stricter online regulations will crush the 26-billion-yen online and mail-order drugstore market. The revised law will ban “class 3” drugs that include some cold medications and painkillers. Opponents say that this ban will prevent people from also purchasing products they would be embarrassed to buy at stores, such as baldness remedies and pregnancy tests.

The Japanese Pharmaceutical Association, the Japan Association of Chain Drug Stores (JACDS), and the Cabinet’s Council for the Promotion of Regulatory Reform support the stricter regulations, citing the inability of online drug stores to guarantee the safety of their drugs.

SOURCE: Stevens Johnson Syndrome › Revised Japanese law limits online purchases of drugs

SJS and TEN are dreadful conditions that cause painful rashes and blisters on the skin and can also affect all orifices including the mouth and eyes. It can lead to blindness or even death. Kim has lost the skin on more than 70 percent of her body. To protect her from the severe pain, she was put into a drug-induced coma.

Every day is a struggle for Kim. Doctors are keeping close watch on her temperature, monitoring her condition, hoping each day that she can be taken off the ventilator for good. Doctors say this is a critical time for Kim as the skin loss makes her more prone to infections from fungi and bacteria that can lead to septicemia, the leading cause of death with TEN. The family has been cautious, even scared to visit her for fear of contaminating her. The family is hoping her two children, Shauna and Hunter Quilty, will be able to visit her on Christmas day.

With more than 2,000 members, the Facebook site is quickly gaining attention from family, friends, and even others who have been touched by SJS and TEN.

SOURCE: Stevens Johnson Syndrome › Family creates support group to raise awareness of SJS/TEN

TOUCH IS THE SENSE OF LOVE
I’m scared,
 You hold me.
I cry,
 You hold me close.
I’m hurt,
 You hold me closer.
Touch is the sense of love.

It’s hard to imagine such a beautiful and beaming girl healthy one minute and hanging in the balance of life the next. Her struggle is laid out in a Web site her parents set up to follow her progress as she recovered from the severe reaction to medication. Photographs and poems written by Kaitlyn offer an insight into the battles she fought and the appreciation she had for those who stood by her:

FAITHFUL FATHER
Faithful father,
Tall, brave and strong.
Faithful father
To him I belong.
It was then he cried,
when I almost died.
Faithful father
My life I depend on you.

Kaitlyn’s family’s nightmare began April 5, 2002, when Kaitlyn began showing signs of the flu. She was treated at an urgent care center the next morning and by Sunday she had a severe rash and high fever. She was admitted to the hospital and her parents watched as their daughter’s health deteriorated.

The diagnosis – toxic epidermal necrolysis (TEN), a severe form of SJS, a rare but life threatening hypersensitivity disorder affecting skin and mucous membranes. The disorder affects all ages and genders, including the pediatric population. It is most often caused by a reaction to medications such as non-steroidal anti-inflammatory agents like ibuprofen and some antibiotics. Kaitlyn’s condition was caused by a common over-the-counter medication, Children’s Motrin.

Kaitlyn passed away on December 17, 2003, due to complications from SJS/TEN, but the Web site has helped those of us who have never met her understand just how extraordinary she was. With hope, maybe her story will prevent another precious child from suffering.

SOURCE: Stevens Johnson Syndrome › Young girl’s struggle with SJS laid out on Web site

Researchers centered their focus on antibiotics that were either ingested or injected rather than those that are applied to the skin. Data was pulled from the National Ambulatory Medical Care Survey, National Hospital Ambulatory Medical Care Survey, National Electronic Injury Surveillance System-Cooperative Adverse Drug Event Surveillance project. The data showed that 19 percent of all emergency visits for adverse reactions to drugs were due to antibiotics.

Seventy-eight percent of the time those adverse events were caused by allergic reactions to the antibiotics and resulted in rashes and anaphylaxis. Other causes were accidental overdoses, unintentional exposures (such as children accidentally taking the medication), and side effects such as headaches, dizziness and diarrhea.

Stevens Johnson Syndrome (SJS) is a rare but serious reaction to medication including antibiotics such as sulfonamides and penicillin. It is defined as a hypersensitivity disorder affecting the skin and mucous membranes and expresses itself first as a simple rash known as erythema multiforme.

Penicillin and similar-type antibiotics accounted for the majority of adverse events that resulted in emergency room visits, with penicillin alone attributing 36.9 percent of the visits. For every 10,000 outpatient prescription visits, reactions to sulfonamides resulted in 18.9 of emergency room visits. Sulfonamides also had a much higher rate of moderate-to-severe allergic reactions compared to medications in other antibiotic classes.

According to Dr. Daniel S. Budnitz, the leader of the study, “Antibiotics are among the most frequently used medications in the United States. Annually, antibiotics are prescribed to an estimated 16 percent of patients during ambulatory care visits, and pharmaceutical manufacturers spend $1 billion promoting antibiotics.” The report continues, “more than one-half of the estimated 100 million antibiotic prescriptions written in the community each year for respiratory tract infections may be unnecessary.”

SOURCE: Stevens Johnson Syndrome › Most emergency visits from drug reactions caused by antibiotics

The Johnson family claimed that Children’s Motrin caused their daughter’s skin to break out in excruciatingly painful rashes and blisters after giving her three doses of the over-the-counter medication. Her eyes blistered over and she was blinded. Sabrina, who was 6 at the time, was diagnosed with Stevens Johnson Syndrome (SJS), which is an extreme adverse reaction to some drugs, including ibuprofen. The active ingredient in Children’s Motrin is ibuprofen.

The family claims that the drug maker did not provide adequate warning of the possible reaction on its medication label. A jury found that the medication’s labeling, which advises consumers to notify a doctor if the child’s symptoms change, was adequate.

“The FDA is not doing anything for us. They are taking care of the prescription drug people. They’re taking care of their billions of dollars. And the few children that die … Oh well,” Joan said in the news report.

The Johnson family is appealing the case. At least nine other lawsuits have been filed by others who have suffered from SJS after taking the medication.

SOURCE: Stevens Johnson Syndrome › Family appeals case against makers of Children’s Motrin

Lamotrigine is an anticonvulsant drug to treat partial seizures, primary and secondary tonic-clonic seizures in epilepsy and seizures associated with Lennox-Gastaut syndrome. It also is FDA-approved to treat bipolar disorder.

Peer View cited a session presented at the American Epilepsy Society’s annual meeting, which detailed a study, conducted between January 2000 and December 2007, involving 403 children treated with lamotrigine in addition to existing therapy. Twenty-one of the children in the study experienced adverse skin reactions including moderate diffuse mascular-papular or erythematous rash, severe urticarial skin eruption and mild Stevens Johnson Syndrome (SJS).

There were no cases of toxic epidermal necrolysis (TEN), a severe form of SJS, however the medication has a black box warning about life threatening skin reactions, including SJS and TEN. The manufacturer says the reactions usually occur in the first 2 to 8 weeks of therapy and if medication is suddenly stopped and then resumed at its regular dosage.

According to Rx List, the incidence of these serious skin rashes in response to therapy for epilepsy is about 8 in 1,000 in pediatric patients younger than 16 years of age and about 3 in 1,000 in adults. For treatment of bipolar disorder and other mood disorders, the rate is about 1.3 to 8 in 1,000 for adults.

SOURCE: Stevens Johnson Syndrome › Risk factors may indicate serious skin reaction to lamotrigine

Within days, everything changed. Kim started having severe headaches and then target-like blotches sprang up on her skin.

The mother of two is now in a coma and on a ventilator, her body wrapped in antibiotic gauze. The severe reaction to the antibiotics has left her without skin on 70 percent of her body. Doctors have given her a 50 percent change of surviving, according to Canada.com.

Kim was diagnosed with toxic epidermal necrolysis (TEN), a severe form of Stevens Johnson Syndrome (SJS), in which the top layer of skin peels off causing painful blisters and lesions. SJS and TEN are most often triggered by drugs such as ibuprofen, antibiotics and anticonvulsants. TEN most severely affects the mucous membranes such as the eyes and mouth causing painful blisters that make eating painful and can cause blindness.

Doctors say now is the most critical time for Kim as the skin loss makes her more prone to infections from fungi and bacteria that can lead to septicemia, the leading cause of death with TEN. Kim’s family is scared to even go into her room for fear of contaminating her. The best news for now is that Kim’s eyes have not been affected, nor are there any signs of organ problems.

SOURCE: Stevens Johnson Syndrome › Canadian woman with TEN fights for life

Elizabeth had been diagnosed with toxic epidermal necrolysis (TEN), a severe form of Stevens Johnson Syndrome (SJS) in which the top layer of skin detaches from lower layers of skin all over the body. SJS and TEN is caused by severe reaction to certain drugs, such as nonsteroidal anti-inflammatory drugs (NSAID) and anticonvulsant medications. The incidence of TEN cases are reported as between 0.4 and 1.2 cases per million each year.

TENS generally affects the mucous membranes and is usually preceded by 1 to 2 weeks of fever. A rash forms and within hours the skin becomes painful and can easily be peeled away from the underlying dermis. The mouth can become blistered and eroded and the eyes can become blistered and ulcerated.

Elizabeth had been sent to Vanderbilt University Medical Center to “ride out” the illness. But as the disease progressed, she was put into a drug-induced coma to help shield her from the excruciating pain. She spent two weeks in the coma before she lost her battle to TEN. Her parents say they do not know what caused the severe epidermal reaction that led to her death, but say they are committed to helping educate other parents of the terrible reaction that killed their daughter.

SOURCE: Stevens Johnson Syndrome › Tennessee girl, 17, loses battle with TEN

Julie McCawley became a victim of SJS when she was just 11 months old. Her mother, Jean McCawley, established the SJS Foundation in 1995 to provide the public and medical communities with information about the adverse allergic drug reactions and to serve as a support outlet for victims of SJS and their families. Today, Julie is 14 years old and as a result of SJS has lost vision in one of her eyes.

Last August, Julie designed a Web site to help educate the public about SJS from a child’s perspective. The SJSKIDSSUPPORT.org site uses cartoons and plain language to explain the disorder. “I hope that it gives healthy kids some insight into why SJS kids may look different on the outside or why many of us are so sensitive to the sun, but that we’re the same on the inside. Then, maybe the next time they meet a person with SJS or any kind of disability, they will be more tolerant of someone who’s not exactly like them,” Julie says in a recent press release.

The Web site also honors the memory of children who have lost their battle with SJS. “The idea for this really is an extension of a special bulletin board that I keep at home that has the photos of children who have died from SJS. Their beautiful faces and tragic stories remind me that we need work harder at educating everyone about the dangers of SJS,” she adds.

Julie’s story can be found on the Foundation’s Web site at www.sjsupport.org. The SJS Foundation sponsors active support groups in 18 states, and through its Yahoo support groups serves adults and children afflicted by SJS from around the world, including Australia, Canada, Europe, Mexico and South Africa.

SOURCE: Stevens Johnson Syndrome › Young SJS victim creates Web site for children with SJS

Chung Wen-hung with Chang Gung Memorial Hospital in Taipei, has discovered that granulysin, a naturally occurring substance in the human body, can attack foreign substances or organisms. This discovery may lead to a therapeutic target for further development of an effective treatment for severe immune-mediated disorders that currently have no satisfactory treatment, according to the report. The report is published in last week’s edition of the biomedical research journal Nature Medicine.

SJS accounts for about half of the cases handled by the Taiwan Drug Relief Foundation. It is a rare and sometimes fatal skin disorder that often is caused by medication. SJS and its more severe form, toxic epidermal necrolysis (TEN), are characterized by painful blistering of the skin and skin lesions.

As the condition evolves and skin cells begin to die, skin can literally slough off. Treatment usually focuses on eliminating the underlying cause, if possible, and controlling the symptoms. Recovery can take several weeks to several months.

Chung’s research also appeared in Nature Medicine four years ago when he discovered a link between carbamazepine, an anti-seizure medicine, and patients with SJS. His discovery prompted the Taiwan Department of Health as well as the U.S. Food and Drug Administration to alert healthcare providers of the possible link and recommend genetic screening for the gene before prescribing the medication.

SOURCE: Stevens Johnson Syndrome › Chinese doctor’s discovery may lead to treatment for SJS

In a recent Information for Healthcare Professionals sheet, the FDA described the increased risk of SJS/TEN with another antiepileptic drug, carbamazepine, in patients of Asian ancestry with the HLA-B*1502 allele. HLA-B is a human gene that provides instruction for making a protein that plays a critical role in the immune system. It is part of a family of genes called the human leukocyte antigen (HLA) complex. This complex helps the immune system distinguish the body’s own proteins from proteins made by viruses or bacteria. Several variations of the HLA-B gene are associated with adverse reactions to certain drugs.

SJS is a disorder of the skin and mucous membranes and often begins with flu-like symptoms followed by inflammation of mucous membranes and a painful red or purplish rash that spreads and blisters. It eventually causes the top layer of skin to die and shed.

Until the FDA completes its review, the agency warns healthcare providers who are considering the use of phenytoin or fosphenytoin for their patients to be aware of the risks and benefits described in the current prescribing information for the drug. Healthcare providers should consider avoiding phenytoin and fosphenytoin as alternatives for carbamazepine in patients who test positive for HLA-B*1502.

SOURCE: Stevens Johnson Syndrome › FDA warns of link between anti-epilepsy drugs and SJS

According to mediafact.com, other medications have been linked to Stevens Johnson syndrome including Bextra, Celebrex and Daypro, as well as over-the-counter pain relievers such as Motion, Ibuprofen, Children’s Motrin and Advil.

One of the main issues with Stevens Johnson syndrome is the lack of awareness from the patients that are at risk and the doctors that prescribe the medication. In a 2007 press release from SmartBrief.com, Governor Bill Ritter, Jr., of Colorado, along with the Stevens Johnson Syndrome Foundation, recognized August 2007 as the designated SJS Awareness month. Joining Colorado in recognizing this month were Arizona, Alabama, Connecticut and Tennessee.

According to the article, Stevens Johnson Syndrome affects more than two million Americans each year and has resulted in more than 140,000 deaths.

When prescribed a new medication, or even taking over-the-counter medication, educate yourself on Stevens Johnson Syndrome so you can identify the symptoms at the earliest possible stage.

SOURCE: Stevens Johnson Syndrome › Drug reactions bring awareness to Stevens Johnson Syndrome

The FDA approved Celgene Corp.’s Revlimid in December 2005 to treat a bone marrow disorder. It was later approved for use in treatment of multiple myeloma, a type of blood cancer. Earlier this month, Revlimid appeared on a list of approximately twenty drugs under investigation by the FDA for possible safety hazards. No details about the specific concerns were made available at that time.

From the drug’s approved use in 2005 to January 23, 2008, the FDA received 14 reports of serious skin reactions following Revlimid therapy. Three deaths occurred among the 14 patients who displayed either SJS or TEN, although progression of cancer is suspected in one of the fatalities.

The estimated incidence of SJS/TEN is 1 to 2 persons per million annually. According to Brian Gill, a spokesman for the manufacturer of Revlimid, approximately 60 thousand people have been treated with the drug. Individuals with SJS normally have 10-30 percent of their body surface area affected by the disorder. SJS-related mortality is estimated to be between 1-3%. People with TEN normally suffer an infliction of more than 30% of their body’s surface area. Mortality ranges anywhere from 10-70%, according to the FDA.

Revlimid currently comes with warnings of other serious hazards, including birth defects and blood clots and is distributed, sold, and used with great restriction. The drug’s labeling will be updated to include reports of skin reactions and doctors are strongly advised to discontinue use in patients that develop skin irritations while taking Revlimid.

SOURCE: Stevens Johnson Syndrome › FDA finds link between Revlimid and skin diseases

“SAEC’s focus is to identify and to validate DNA variance or genetic markers that are useful in predicting a drug-induced serious adverse event,” Arthur Holden, the chairman of the group, said during a midmorning teleconference Thursday.

The findings of the consortium could have an impact on improving the ability of patients to safely use existing drugs, Holden added. “We hope it will improve the productivity and effectiveness not only for those who develop drugs but for those who regulate drug development,” he said.

“The immediate goal would be to develop a test that could identify who will have a problem with a drug before they get it,” said Dr. Paul Watkins, director of the General Clinical Research Center at the University of North Carolina in Chapel Hill. “The ultimate goal is to look at the genes that are causing the susceptibility and work back to figure out how we can design drugs differently so that no one would have that problem,” he added.

“The two drug reactions that are being studied, Stevens-Johnson and liver toxicity, are very common reasons for problems with drugs either being restricted, not being developed, not being approved or being pulled off the market,” said Dr. Janet Woodcock, Deputy Commissioner and Chief Medical Officer at the U.S. Food and Drug Administration.

“This effort is part of personalized medicine — personalized safety — that will make treatments safer by understanding individual benefits and risks,” she added. “This will help in the development of drugs both in avoiding these side effects in the future and maybe developing tests to help identify people at high risk,” she said.

Findings from these studies could lead to the FDA requiring genetic tests to determine risk before the drug is prescribed, Woodcock added.

A recent survey found that most Americans are more concerned with drug safety than with speeding more medications to the marketplace.

Members of the consortium include Abbott, GlaxoSmithKline, Johnson & Johnson Pharmaceutical Research & Development, L.L.C., Pfizer, Roche, Sanofi-Aventis and Wyeth. In addition, the FDA will consult on the design and conduct of SAEC studies.

The actual research will be done at academic centers in Europe and the United States.

The results of the studies will be made public domain, and none of the companies will have early access or be allowed to patent the findings. When the results are made public, any company can develop and sell the genetic tests that predict side effects.

SAEC is one of several consortiums formed by the pharmaceutical industry to conduct basic research. One of the first was started in 1999 and was headed by Holden. That consortium looked for DNA variations among people. Their data were also put into the public domain.

October 17th, 2007

SOURCE: Stevens Johnson Syndrome › Drug industry seeks tests to spot side effect risks