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The Food and Drug Administration asked Pfizer Inc. to withdraw its arthritis drug Bextra because of the risks of increased heart attacks, strokes and a potentially fatal skin disease called Stevens Johnson syndrome.

Bextra’s removal from the market on April 7, the result of requests from both the FDA and European regulators, affected millions of people in the United States and the European Union. Belonging to the same class of drugs as Merck & Co.’s Vioxx, Bextra’s safety has been closely scrutinized for the past six months in response to last September’s Vioxx recall announcement.

When Vioxx was taken off the market for increased risks of heart attacks and strokes, many experts worried the drug risks were indicative of a class-wide effect. In February, an advisory panel to the FDA met, and in a three-day meeting convened to determine the risks of COX-2 drugs (which includes Vioxx, Bextra and Pfizer’s blockbuster drug Celebrex) the panel narrowly voted that despite Bextra’s risks, the drug should remain on the market.

Pfizer disagreed with the FDA’s request to withdraw Bextra, which brought in $1.3 billion in sales last year, but there have been many critics of both COX-2 drugs and the FDA since the Vioxx recall. Consumer groups have applauded the FDA’s decision to withdraw Bextra, as well of critics of the FDA who believe the agency has gotten too close to the companies it is supposed to be regulating.

In January, director of the Public Citizen Health Research Group, Dr. Sidney Wolfe, petitioned to have Bextra and Celebrex removed from the market because of cardiovascular risks. Though Wolfe was pleased with the FDA’s decision to ban Bextra, he said the FDA should also ban sales of Celebrex. Last year, 23.9 million prescriptions were sold for Celebrex compared to 12.9 million in Bextra prescriptions.

Another watchdog group, Consumers Union, agreed with the FDA’s decision to suspend the sales of Bextra, but senior policy analyst for Consumers Union, Jeannine Kenney, said the larger question involved with the Bextra recall is “why were these unsafe drugs being sold in the first place?” Pfizer’s announcement to remove Bextra came at the same time the FDA also issued its strongest black box warnings for other non-steroidal, anti-inflammatory drugs called NSAIDS, which includes Pfizer’s blockbuster drug Celebrex, as well as 19 prescription strength and over-the-counter products like Advil, Aleve and Motrin.

The public attention on the Vioxx withdrawal and the safety concerns following, as well as some strong criticism from Congress of the FDA’s effectiveness has raised questions about forming a more independent drug safety office within the FDA.