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, other cardiovascular injuries and Stevens Johnson Syndrome.
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 If these 10 advisers had not cast their votes, the committee would have voted 12 to 8 that Bextra should be withdrawn.
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 prescribed for the treatment of adult rheumatoid arthritis, and the pain associated with menstrual cramping.
Bextra has also been linked to Stevens Johnson Syndrome and other skin hypersensitivity
Stevens Johnson Syndrome is an extreme allergic reaction to chemicals. Common causes are the drugs including Arava (leflunomide), painkillers, and sulfa 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, sores in the genital tract causing painful urination, skin rash, difficulty breathing. Patients who have severe allergies to antibiotics should not use Bextra.
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. Following the Vioxx recall, questions arose about the similar pain pills from Pfizer, 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.
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