The painkiller Bextra was removed from the market Thursday by Pfizer Inc. at the request of Food and Drug Administration officials who said concerns about side effects such as life-threatening skin reactions and heart problems outweigh its benefits.
Painful and dangerous side effects linked to Bextra include blisters of the skin and mucous membranes, skin lesions, flulike symptoms, high fevers, severe peeling of deadened skin, severe eye irritation, blistering and erosion, and, in some cases, death.
The FDA also requested Thursday that 19 other prescription pills in the same drug class as Bextra – among them Pfizer’s Celebrex – carry a black box warning of an increased risk of strokes, heart attacks and gastrointestinal bleeding in millions of users, many with arthritis. Drugs in this class are called NSAIDS – nonsteroidal anti-inflammatory drugs.
The FDA also wants Pfizer to do long-term safety studies on Celebrex.
Additionally, the agency has asked manufacturers of nonprescription painkillers such as Advil and Aleve, which are related to drugs such as Bextra and Celebrex, to warn about heart and gastrointestinal risks on their labels.
The withdrawal of Bextra – a pill known as a COX-2 inhibitor – from drugstore shelves comes on top of an already gloomy outlook for Manhattan-based Pfizer, which announced $4 billion in cost-cutting earlier this week.
Bextra’s misfortunes follow the withdrawal of a related drug – Merck’s painkiller Vioxx – from the market last September after reports of fatal strokes and heart attacks associated with it. Bextra and Vioxx are both NSAIDS.
“FDA is providing the public information based on the latest available scientific data to guide the careful and appropriate use of these drugs aimed at maximizing their potential benefits and minimizing their risks,” said Dr. Steven Galson, the FDA’s acting director for drug evaluation and research.
Galson said clinical investigations into the drugs’ side effects are continuing.
In February, an FDA advisory panel voted 17-13 to keep Bextra on the market. The FDA requested the painkiller’s removal despite that vote. The same panel recommended Vioxx be returned to the market but that has not happened.
In November, Pfizer added a black box warning to Bextra’s label, noting the skin problems and fatalities.
Jason Napodano, an analyst with Zacks Investment Research in Chicago, said Thursday the FDA action removes about $450 million from Pfizer’s 2005 sales.
Dr. Valentin Fuster, director of the cardiovascular institute at the Mount Sinai School of Medicine in Manhattan, said it is likely the FDA is not just concerned about skin reactions to Bextra but also about the lack of information concerning its long-term effects.
Sidney Wolfe, director of the nonprofit Public Citizen Health Research Group in Washington, D.C., criticized the FDA for not removing Celebrex from the market along with Bextra. Wolfe’s group asked the FDA in January to remove both Bextra and Celebrex from the market.
“Further danger occurs when the FDA says it will leave Celebrex on the market,” Wolfe said.
FDA officials said Thursday the benefits of Celebrex outweigh its risks.
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