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Public Citizen petitioned the FDA to immediately remove two popular Pfizer Inc. drugs from the market because of concerns they increase the risk of heart attacks in patients.
Celebrex and Bextra belong to a class of drugs called COX-2 inhibitors, which have been highly popular because the belief they caused fewer gastrointestinal effects than older pain relievers like aspirin or ibuprofen. Over the years, the benefits of COX-2 drugs have been questioned amidst growing concerns that the drugs were linked to cardiovascular events.
Despite rising safety concerns, 23.9 million prescriptions for Celebrex were filled in 2004 in the United States alone, with 12.9 million Bextra prescriptions filled. Last September, Merck & Co. pulled its COX-2 inhibitor, Vioxx, from the market after a clinical study showed it increased the risk of heart attacks. The Vioxx recall prompted safety concerns over the entire class of COX-2 drugs, though Celebrex and Bextra recalls were not issued.
Public Citizen''s Health Research Group director, Dr. Sidney Wolfe, believes the FDA should “immediately ban the sale of Celebrex and Bextra, which put millions of people, many of them elderly, at risk of heart attack.” In addition to safety risks, the consumer group points out the drugs are more expensive and present greater risks than older pain relievers while providing no better gastrointestinal tract benefits.