Consumer group wants Bextra, Celebrex pulled from the market

• In a formal petition to the U.S. Food and Drug Administration, Public Citizen said the two drugs' potential to cause heart attacks and strokes outweighed any possible benefit.
• The letter, a copy of which was obtained by Reuters, is the latest action following a series of warnings over heart problems connected to both prescription and over-the-counter painkillers.
• Merck Inc. pulled its arthritis drug, Vioxx, from the market in September after a study showed its doubled the risk of heart attack and stroke.
• Last month, the National Institutes of Health halted two studies involving Celebrex and naproxen, a nonprescription painkiller sold as a generic and under several brand names, including Bayer AG's Aleve and Roche AG's Naprosyn.
• Pfizer has kept Celebrex on the market but agreed to suspend consumer advertising.
• It also placed a note on Bextra warning of increased risk in patients who have just had heart bypass surgery.
• The FDA has called on doctors to limit prescribing of Celebrex and Bextra, and an FDA advisory panel of outside experts plans to meet for an unusual 3-day meeting to discuss the entire class of drugs.
• In its letter sent Monday, Public Citizen said Pfizer's drugs have not been proven any safer than older non-steroidal, anti-inflammatory painkillers, known as NSAIDs, like aspirin or naproxen.
• Public Citizen researchers analyzed results from 14 randomized trials involving all drugs in the class that includes Celebrex and Bextra -- known as Cox-2 inhibitors.
• Arcoxia is approved in the European Union, but the FDA rejected the experimental drug in October, requesting more data.
• Novartis pulled its application for EU approval in November, saying it would provide more data, and has said it is working to get the drug approved in the United States.