In July, the FDA issued a warning to health care professionals and consumers about dietary supplements marketed as an alternative to anabolic steroids for body building and increasing muscle mass and strength. Although marketed as dietary supplements, the FDA says the products are actually unapproved new drugs that have not been reviewed by the FDA for safety and effectiveness. At that time, the agency had received reports of adverse events following the use of several of these "steroid alternative" products made by various companies.

Earlier this month, the FDA began issuing recalls of these products, beginning with all lots and expiration dates of 65 BodyBuilding.com brand dietary supplements. Two weeks later, the FDA announced the recall on the IDS Sports products.

Steroid use has been associated with acute liver injury. Other serious long-term adverse health consequences in men, women and children include shrinkage of the testes and male infertility, masculinization of women, breast enlargement in males, short stature in children, a higher predilection to misuse of other drugs and alcohol, adverse effects on blood lipid levels, and increased risk of heart attack, stroke and death.

No illnesses or adverse events have been reported to the company to date in connection to the IDS Sports products listed in the recall. However, the agency urges consumers who have these products in their possession to stop using them immediately and contact their physician if they have experienced any problems that may be related to using one or more of the products. Any adverse events that may be associated with the use of these or any other products should be reported to the  FDA's MedWatch Adverse Events Reporting program at www.fda.gov/MedWatch/report.htm. 

Site: Beasley Allen

The ViperSheath Inducer is a long-coil reinforced, kink-resistant catheter sheath. Thomas Medical initiated the recall due to the possibility of fractures in the device. In the event of a device fracture, separated segments of the device may require unplanned open surgery. Since this device is coil reinforced, any separation of the cannula (a flexible tube inserted into the body) has the potential to expose portions of the coil, creating the potential for vessel dissection or perforation.

The recall includes products distributed from March 25, 2009 to October 21, 2009, and includes the following lot ranges and catalog numbers:

• Lot range: S28117 through S29174
• Catalog numbers: VPR-ISH 5 X 85, VPR-ISH 6 X 85, VPR-ISH 7 X 85, VPR-ISH 5 X 45, VPR-ISH 6 X 45, VPR-ISH 7 X 45

To date, CSI is aware of three instances where a ViperSheath Sheath Introducer encountered the issues related to this product. No permanent patient injuries have been reported. In these instances, successful surgical interventions were performed to retrieve a portion of the sheath.

CSI has notified all customers by FedEx about the recall and is arranging for the return of all products. Customers with questions may contact CSI at 1-877-274-0360.

Source: FDA

Site: Beasley Allen

Since clopidogrel may cause bleeding in the stomach, omeprazole may be used in combination to reduce the production of stomach acid and prevent stomach bleeding. Other medications that are expected to have the same effect and should be avoided in combination with clopidogrel include cimetidine, fluconazole, ketoconazole, voriconazole, etravirine, felbamate, fluoxetine, fluvoxamine, and ticlopidine.

Patients using clopidogrel should consult with their health care provider if they are current taking or considering taking omeprazole, including Prilosec OTC, and always consult with their health care provider before starting or stopping any medication. This includes telling their doctors about any over-the-counter medications they are taking before starting or while using clopidogrel.

Patients who are taking clopidogrel and need a medication to reduce stomach acid can use antacids such as Maalox or Mylanta, or most acid reducers such as Zantac (ranitidine), Pepcid (famotidine), or Axiid (nizatidine) because the FDA does not believe that these medications will interfere with the anti-clotting activity of clopidogrel. However, Patients who use clopidogrel should avoid Tagamet and Tagamet HB (cimetidine). Many of the products listed above are available both over-the-counter and by prescription.

Site: Beasley Allen

Site: Beasley Allen

Toyota formally notified the NHTSA of the recall in a letter on October 5. Owners of the recalled vehicles, which include eight Toyota models manufactured in the last six years, are being notified by first-class mail in a mailing that was sent out on Friday, October 30th.

This first mailing will alert owners to the potential dangers posed by the floor mats but will not announce a fix. When Toyota decides on a solution, it will contact owners about the availability of a free remedy in a second mailing.

Some early reports indicated that rather than focusing on the floor mats, Toyota was researching on-vehicle countermeasures such as a "smart pedal" that would tell the vehicle to ignore the gas pedal if the brakes were applied simultaneously. Such a measure, which is standard in most German-made vehicles and Chryslers, would enable drivers to regain control of their vehicles easily and instantly despite the cause of unintended acceleration.

However, retrofitting 3.8 million vehicles with smart pedal technology would be extremely costly.  A modification to the pedal in the affected vehicles would cost as much as $440 million, according to a Tokyo Shimbun report cited by Reuters.

A recall involving redesigned floor mats, on the other hand, would cost about $100 million. New reports say that the latest Toyota recall will indeed be a floor mat fix of some kind.

Toyota's largest recall comes during its toughest financial time. The company expects to lose $4.7 billion for the year ending March 31 -- its second consecutive annual loss. The economic downturn and a poor exchange rate are obvious culprits, but according to Toyota President Akio Toyoda, the troubles run even deeper.

"Toyota has become too big and distant from its customers," President Akio Toyoda, he told journalists in Tokyo last month. "We are grasping for salvation," he added, after apologizing for an accident that occurred in San Diego last August, which investigators say was caused when a floor mat jammed the accelerator pedal in a Lexus ES 350. The horrific accident claimed the lives of a California Highway Patrol officer and three of his family members, finally prompting the massive recall.

Until Toyota develops a fix, owners of the recalled vehicles should remove their driver's side floor mats immediately. "This is an urgent matter," transportation secretary Ray LaHood said in a statement last month. "For everyone's sake, we strongly urge owners of these vehicles to remove mats or other obstacles that could lead to unintended acceleration." 

The recall encompasses the following Toyota and Lexus models: 2007 - 2010 Camry; 2005 - 2010 Avalon; 2004 - 2009 Prius; 2005 - 2010 Tacoma; 2007 - 2010 Tundra; 2007 - 2010 Lexus ES 350; and 2006 - 2010 Lexus IS 250 and 2006 - 2010 Lexus IS 350. 

Site: Beasley Allen

In seven starts in 2009, in his own no. 83 BeasleyAllen.com sponsored Ford Fusion, Enfinger checked off four top-five finishes among a couple of near wins at Kentucky and Chicagoland, where he finished second. Third place finishes at Talladega and Kansas, and a seventh at Rockingham served notice that this guy's the real deal.

"I'm fairly satisfied," said Enfinger. "Our performance probably exceeded the expectations of the guys who helped us at Beasley Allen. We're still searching for a little more. I'm disappointed with didn't pull off the win, but overall, I'm satisfied."

Enfinger first got the attention of the troops at Talladega where he steered the BeasleyAllen.com Ford to third in final running order behind '09 champ Justin Lofton and '99 champ Bill Baird. Not too shabby.

Then Enfinger proved he was no one-race wonder when he led 35 laps at Kentucky, giving up the lead only in the final corner of the final lap to Parker Kligerman. Up to that point, Enfinger and Kligerman wowed the live SPEED TV audience with an ongoing bumper-to-bumper, door-to-door dual over the last 30 laps. Even National Speed Sport News publisher emeritus Chris Economaki commented in his weekly column that it was the best stock car race he had witnessed all year. It was, indeed, that good. 

"We are a very low budget team, just stringing parts and pieces of this car together to try and make it work, and a finish like this really means a lot," said Enfinger right after the race at Kentucky.

Even though the car belongs to Enfinger, many of the pieces and parts that ultimately make it go are rented and/or borrowed.

"We rented some shocks; actually a couple of team let us borrow them. Rick Crawford from Circle Bar Racing let us borrow some gears. Other guys let us use their sway bars and springs. Everything we borrowed, we had to give back."

Enfinger also gets a lot of good advice from his good buddy David Ragan, both fellow Alabamians.

"David (Ragan) comes to the shop all the time. I've always leaned on him for advice about tracks I've never been to, and the business side of things. Rick Crawford's from Mobile; we've known each other for ever, so I lean on him for advice all the time too."

Enfinger, who sets up shop these days in the Mooresville, North Carolina area, has been back home this week in Alabama working on a late model.

"I'm gonna run in the Snowball Derby (December 6), so I'm getting the car ready. Josh and George Braggs field the car for me so I'm down here getting things ready.

"Other than that, I've been working on the Daytona car getting ready for the ARCA test (December 18, 19, 20). We're prepping for the test but everything's kind of up in the air right now.

"I've got some options. Some guys approached us, but nothing solid that's for sure. My goal would be to run the full season in ARCA with my own team, but nothing's far enough along to say that. I'm not sure I'm ready to be anywhere else. I really like the ARCA series, and I think it's where I need to focus right now."

In just over a half-dozen starts this year, Enfinger taught himself a lot.

"I definitely learned a lot. I don't think there's a better series out there that can prepare drivers for the next level. This was the first year I could actually race. The biggest thing I learned was that, as a driver, I have a lot more to gain. And as a team, there's a lot more to be learned, and this is the place to do it. This was my first year on bigger tracks, and I need to do a lot more of that before we try and step up."

From a team standpoint, Enfinger never really had the luxury of working with the same people from race to race.

"We didn't ever have the same pit crew, didn't have the same spotter either. That said, I didn't really expect to come here and contend for wins. But it probably didn't surprise me as much as it did Beasley Allen, which they are the reason we ever got this opportunity to begin with. They knew what we were up against here. I'm sure they were expecting some possible top-10s on a good weekend, but didn't expect to contend for wins."

And with all the borrowed pieces, parts and people, that's exactly what Enfinger did every time he sat the in the car.

"I'm going to Talladega this weekend. Gunna shake as many hands as I can - try and get some direction for next year."

Site: Beasley Allen

The U.S. Consumer Product Safety Commission, which releases a Halloween Safety Alert each year, always emphasizes the safety of costumes. Customers should look for a tag or label that designates costumes, masks, wigs, and other accessories as "Flame Resistant." Jack-o-lanterns are typically lit with candles and placed on stair cases, porches, and other places around entryways, posing a fire hazard to children who aren't mindful of the flames.

Customers should know that a costume labeled as flame-resistant can still catch fire. The label means that the item will resist burning when removed from the flame or other ignition source and should extinguish quickly if it does catch on fire. The CPSC recommends that consumers avoid donning baggy or billowing costumes and costumes that are made of delicate materials. Doing so will minimize the risk of burn injuries.

Costumes should be visible, especially to motorists. Vampires and witches watch out -- the CPSC says that costume colors should be "light and bright." All costumes, regardless of color, should be decorated or trimmed with reflective tape that will glow in a car's headlight beams. Hardware, sporting goods, and bicycle stores normally sell reflective tape.

Because loose hats and scarves can slip over the face and obstruct a child's vision, they should be tied or safely secured. The CPSC recommends wearing facial makeup rather than masks, but says that if masks are used, they should be secure and not obstruct vision. Accessories such as knives and swords should be made of soft and flexible materials only. To minimize the risk of fall injuries, costumes should be trimmed short enough to prevent kids from tripping. Children should not wear loose or ill-fitting shoes such as high heels when walking from house to house.

As an extra precaution, all children should carry flashlights, which will help them to walk safely in the dark while making them even more visible to cars. (Please note there is a recall on a type of Halloween flashlight sold exclusively at Target stores.)

When trick or treating, adults or older children should always accompany young children.  Because kids can sometimes be excited and anxious to get to the next house, the CPSC stresses that children should not run but WALK from house to house. Supervisors should remind children to walk on the sidewalk if there is one, not to run out from between parked cars, and not to run across yards. Both the darkness and costumes can impair vision, making it easy for children to run into lawn ornaments, furniture, clotheslines, and other dangers.

Children should avoid darkened homes or homes where the residents are not known. Homes that celebrate Halloween typically leave an outside light on as a sign of welcome and display Halloween decorations. Children should never enter a home unless they are accompanied by an adult.

People who remain at home to welcome trick-or-treaters should remove obstacles from the lawn, steps and porches. Any candle-lit jack o'lanterns should be kept clear of landings, doorsteps, and balusters where they may come in contact with costumes and create a fire. They should also be kept away from decorations, curtains, furniture, and other objects that can catch fire.

When the trick or treating is over, it is important that adults carefully inspect the candy that the children have collected, discarding any open, unsealed, and suspicious looking packages.

Be mindful of your pets' safety too! Be sure to keep cats indoors where they are safe from monsters. Keep dogs in a safe place, too, where they won't be upset by strangers or people wearing costumes. While the evening may be light and festive, it can turn deadly for a pet that consumes alcohol, chocolate, and other substances toxic to animals.

For more tips on how to keep Halloween safe and fun, visit the CPSC's website or Halloween-Safety.com.

Site: Beasley Allen

Nutro Products recalled several lots of dog foods with a best-by date of Sept. 10 after finding pieces of a worker's plastic hat in the production line. The company determined that the final products probably did not contain any plastic.

The recall applies to Nutro Ultra Puppy food in 4.5-pound packages, bar code 79105 51313, and Nutro Natural Choice: Chicken Meal, Rice and Oatmeal Formula Small Bites Puppy food in 5-pound packages, bar code 79105 23050, from PetSmart stores in Arizona, California, Colorado, New Mexico, and Texas.

The recall also affects Nutro Ultra Puppy food in 30-pound packages, bar code 79105 51315, from Petco stores in California, Hawaii, Nevada, and Utah. For more information on the Nutro Products recall click here.

Site: Beasley Allen

Site: Beasley Allen

When asked why she had spoken out against the vaccines, Dr Harper said it was a matter of conscience. "I want to be able to sleep with myself when I go to bed at night," she told The Bulletin, a Philadelphia newspaper.

Dr. Harper explained that 90 percent of HPV infections resolve themselves after 2 years, and that the vast majority of those cases (70 percent) actually resolve unaided in under one year's time.

Moreover, the number of cervical cancer cases in the United States is so low that vaccines and PAP screenings would not lower the cervical cancer rate unless 70 percent of the population was vaccinated. And even then, the cancer rate decrease would be minimal.

According to Dr. Harper, preventative measures and traditional therapies have already cut the cervical cancer rate by 4 percent a year. With these current treatments, she said, HPV will be nearly eradicated in 60 years. Gardasil could not claim to do as much as traditional care is already doing, even if 70 percent of the women received vaccinations and booster shots in that same period of time, Dr. Harper explained.

Essentially, the risks of adverse side effects caused by the vaccine are much greater then the risks of developing cervical cancer.

Alarmingly, Merck never conducted any trials for Gardasil's efficacy in girls under 15 years old, yet girls as young as 9 are often pressured to receive the vaccine.

Dr. Harper said in a 2007 interview that Merck's push to have young girls vaccinated was actually "a great big public health experiment." When Merck lobbied to make the vaccine mandatory in public schools, Dr. Harper spoke out. She alleges that she tried to get television and print media to pick up the story, but no one was willing to air her concerns.

Since Gardasil was first unleashed on the population in 2006, more than 15,000 girls have reported adverse side effects to the Vaccine Adverse Event Reporting System (VAERS). Reactions that have been officially reported include brain inflammation, seizures, blood clots, paralysis, lupus, Guilliane Barre Syndrome, and several others. Forty-four deaths attributed to the vaccine have been reported to the Centers for Disease Control and Prevention (CDC).

According to a news release from Glaxo-Smith-Kline, that company's HPV vaccine Cervarix was just approved for use in the United States by the U.S. Food & Drug Administration (FDA), on Oct. 16, 2009. It is not yet in use in this country, but is in use in Australia and Europe. It has been linked to more than 2,000 cases of serious, adverse reactions since the U.K. government began administering it to schoolgirls last year. One of the worst cases involved 14-year-old Natalie Morton, who collapsed and died in school in England just one hour after receiving the vaccine.

Site: Beasley Allen