Pharmaceutical Injuries - Bextra

Have You Sustained a Personal Injury from Bextra?

On April 7, 2005, the FDA and European regulators formally asked Pfizer to suspend sales of Bextra in the United States and Europe. As a result, Pfizer announced it would halt sales of the drug in the United States and the European Union countries immediately. The FDA stated that the risks posed by Bextra outweigh its benefits. These risks include a high rate of heart attacks, strokes and Stevens Johnson Syndrome.

Bextra (generic name: valdecoxib), a Cox-2 Inhibitor drug, is in the same drug family as Vioxx, Celebrex and Naproxen. People prescribed Bextra have experienced a higher number of heart attacks, strokes and other cardiovascular problems. Bextra is a COX-2 inhibitor, marketed by Pharmacia Corporation and Pfizer Inc. in the United States. The drug is prescribed for the treatment of osteoarthritis, adult rheumatoid arthritis, and the pain associated with menstrual cramping.

FDA advisory committee hearings held in February 2005 examined whether Celebrex and Bextra offered enough benefits to stay on the market, if they needed stronger warnings and what further research was needed. The advisers met from February 16, 2005 through February 18, 2005 and ultimately voted to keep Bextra on the market. The New York Times reported that 10 of the 32 government drug advisers who voted to keep Bextra and the other COX-2 drugs on the market have consulted for pharmaceutical manufacturers. If these 10 advisers had not cast their votes, the committee would have voted 12 to 8 that Bextra should be withdrawn.

Studies "strongly suggest" the entire class of drugs called COX-2 inhibitors elevates the chances of cardiovascular problems, Dr. Ned Braunstein, senior director of Merck Research Laboratories, told the panel of FDA advisers. In November 2004, a study was presented at the American Heart Association meeting in New Orleans indicating that the incidence of heart attacks and strokes in patients taking Bextra (valdecoxib) was twice that of the placebo. This study included 5,930 patients from 12 trials and found 2.19 times the number of heart attacks or strokes among patients given Bextra compared with those given placebos.

Merck voluntarily withdrew Vioxx in September after a study showed the drug doubled the risk of heart attack and stroke in patients who took it for at least 18 months. Since the Vioxx recall, questions have arisen about similar pain pills from Pfizer Inc., Celebrex and Bextra, as well as non-prescription drugs such as Naproxen (Aleve). All pain drugs in the class known as cox-2 inhibitors increase the risk of heart attacks and strokes, a top scientist told a US regulatory panel. Dr Garret Fitzgerald, a cox-2 expert and researcher at the University of Pennsylvania, said the body reacts in the same way to drugs including Merck's Vioxx and Pfizer's Celebrex and Bextra. Dr Fitzgerald said the drugs create an imbalance in the body's cardiovascular system that leads to an increased risk of heart attacks and strokes.

Bextra has also been linked to Stevens Johnson Syndrome, and other skin hypersensitivity disorders. Stevens Johnson Syndrome is an extreme allergic reaction to chemicals. Common causes are the drugs including Arava (leflunomide), painkillers, and antibiotics. Bextra has now been linked to this potentially life threatening syndrome. Symptoms of Stevens Johnson Syndrome are blistering, fever, cough, malaise, swelling and lesions of gums, tongue, or lips, excessive tearing or "stickiness" of eyes and sores in the genital tract causing painful urination. Patients who have severe allergies to antibiotics should not use Bextra. If you develop any of the following symptoms consult your doctor immediately. Other symptoms of Stevens Johnson Syndrome include: Skin Rash, Swelling of Face, Lips and Tongue, Difficulty Breathing, and Swelling or blistering of Skin.

More Information on Bextra
FDA Bextra Recall Information

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