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FDA goes against recommendations of its advisory panel and bans Bextra

-April 7, 2005

After six months of questions regarding the COX-2 inhibitor class of drugs, including Merck & Co.'s Vioxx and Pfizer Inc.'s Celebrex and Bextra, the FDA has asked Pfizer to remove Bextra from the market.

Though Pfizer said it disagreed with the FDA's request to withdraw Bextra, the company has stopped sales of its $1.3 billion in sales a year drug in the United States and the European Union. The safety of COX-2 drugs has been under scrutiny following last September's Vioxx recall because of a study that linked the drug to heart attacks and strokes.

Vioxx, Bextra and Celebrex were said to limit gastric upset and bleeding caused by other anti-inflammatory drugs, but questions about the actual benefits of the drug class was raised when Vioxx was taken off the market. Because of the public controversy the Vioxx recall helped set off about the safety of Celebrex and Bextra, in addition to questions about the FDA's ability to adequately protect the public from dangerous drugs, an advisory panel met in February for three days to discuss the drugs' dangers.

The panel barely voted in favor of allowing Bextra to remain on the market, though it did recommend it carry the agency's strongest drug warning indicating the risks of heart attacks and strokes it presented. Bextra already carried a black box warning for the risks of a potentially fatal skin disease called Stevens Johnson syndrome.

Because of the panel's vote, Pfizer officials contend the government went against advice from an FDA panel of doctors and scientist. Even though the FDA usually follows its panel's recommendations, the agency is not required to do so.

The vote narrowly favoring Bextra resulted in the FDA rejecting the advisory panel's recommendation, stating the potential benefits to patients from Bextra carried less weight than the potential risks, especially because a similar drug with fewer risks was still on the market - Pfizer's Celebrex. Along with the announcement that Bextra was being taken off the market, the FDA issued its strongest black box warnings for Celebrex and 19 prescription and over-the-counter products, including Advil, Aleve and Motrin.

The Public Citizen consumer group petitioned the FDA in January to have Bextra and Celebrex removed from the market because they raise the risk of heart attacks, and while the group agreed with the FDA's actions for stronger warnings, it also continues to support a ban on Celebrex. Last year, according to the group, there were 23.9 million prescriptions sold for Celebrex compared with 12.9 million for Bextra.

In a statement issued on the day of the Bextra recall announcement, the group said, "neither Bextra nor Celebrex protects the gastrointestinal tract as drugmakers claim." COX-2 drugs were believed superior over older drugs because they were thought to limit gastric upset and bleeding caused by other anti-inflammatory drugs, but the real benefit of the drugs has been questioned in recent months.

Pfizer currently ranks as the world's largest drug maker.

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