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Bextra recall a sign of tougher drug safety?

-April 11, 2005

The FDA has been the object of great criticism in recent months. Some influential members of Congress, including Senate Finance Committee Chairman Charles E. Grassley (R-Iowa), have been pushing for a more independent drug safety office within the FDA.

The FDA, according to some critics, has been ineffective in protecting public safety from dangerous drugs in part because of its very close relationship the agency has formed with the companies it is supposed to be regulating. Criticism of the FDA multiplied after last September's announcement that Merck & Co.'s blockbuster drug Vioxx was being recalled from the market.

Vioxx was removed after studies indicated the drug caused risks of heart attacks and strokes among patients, and alongside the recall announcement came questions regarding the entire class of drugs Vioxx belonged to called COX-2 inhibitors. The popular class of drugs also included Pfizer Inc.'s Celebrex and Bextra.

In January, Public Citizen consumer group petitioned the FDA, requesting Pfizer's Celebrex and Bextra be immediately banned from the market. Because of all the safety questions surrounding COX-2 drugs, an advisory panel to the FDA met for three days in February to discuss the drug concerns. In a narrow margin, the panel voted to allow Bextra to remain on the market, though most members agreed it carried serious risks for heart attacks and strokes.

In addition to the cardiovascular risks Bextra presents, the drug is also linked to a potentially deadly skin disease. Against the panel's recommendations, the FDA said Bextra's benefits do not outweigh its risks, leading the agency to ask Pfizer to remove Bextra from the market. Pfizer said it disagreed with the agency's request, though the company halted sales in both the United States and the European Union in response to requests by regulators.

Some FDA critics are encouraged by the FDA's latest decision, believing the Bextra withdrawal displays the agency's desires to show it can respond aggressively to safety concerns. Others believe the FDA actions are too little too late.

Public Citizen still wants Celebrex removed from the market, especially considering sales of the drug was nearly two times as popular as Bextra last year and both drugs fail to protect the gastrointestinal tract as drugmakers claim, and Consumers Union asks why the unsafe drugs were allowed to be sold in the first place. Other critics of the regulatory agency hope that after some of the pressure and scrutiny is lifted that the interests of the general public in regards to unsafe drugs will continue to remain as the top priority.

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