Recall Information
The US Food and Drug Administration (FDA) approved Bextra (generic name: valdecoxib) on November 16, 2001. Its intended use was to relieve symptoms of osteoarthritis and rheumatoid arthritis (RA) in adults and to relieve painful menstrual cycles. On April 7, 2005, the FDA and European regulators formally asked manufacturer Pfizer to suspend sales of Bextra in the United States and Europe. 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. Pfizer then announced it would halt sales of the drug in the U.S. and the European Union countries immediately.
Bextra, 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 than those not on the drug. Bextra marketed by Pharmacia Corporation and Pfizer Inc.
FDA advisory committee hearings held in February 2005 examined whether Celebrex and Bextra offered enough benefits to stay on the market, whether they needed stronger warnings, and what further research was needed. The advisers met from February 16 through February 18 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 If these 10 advisers had not cast their votes, the committee would have voted 12 to 8 that Bextra should be withdrawn.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 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 Merck's Vioxx as it does to 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 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 these symptoms, consult your doctor immediately. Other symptoms of Stevens Johnson Syndrome include: skin rash, swelling of face, and difficulty breathing.
