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Public Citizen calls for drug ban

December 27, 2004

After the Vioxx recall, the FDA has been the target of growing criticism. The Vioxx recall, according to many critics, was just the latest example of the drug agency's inability to adequately protect the public from dangerous drugs. Many experts wondered if the potentially deadly cardiac Vioxx effects that resulted in the drug recall were a class wide effect.

Following Vioxx's removal from the market, only two other drugs in the same drug class as Vioxx remained - Pfizer Inc.'s Celebrex and Bextra. Within months of the Vioxx recall a Bextra warning was added to the drug's labeling and warnings issued linking Celebrex to similar events as Vioxx. The flurry of drug warnings caused many people to question if the FDA was simply overreacting in response to increased scrutiny and criticism.

According to Sidney Wolfe, the director of Public Citizen's Health Research Group, the FDA is not overreacting. If looking at the last ten years, Wolfe thinks "there is overwhelming evidence that the FDA repeatedly delayed withdrawing many drugs long after clear, unequivocal evidence of risks that outweighed any demonstrable benefits."

Vioxx, Celebrex and Bextra are all part of the Cox-2 inhibitor class of drugs. When approved, Wolfe said there was no evidence they were more effective than older drugs. The FDA is supposed to base decisions to approve or remove drugs on adequate evidence of both the benefits and risks, and Vioxx was the only drug that proved to be less dangerous to the gastrointestinal tract than older drugs, though it was taken off the market after significant increases in heart attack and stroke risk were discovered.

Even though Vioxx and Celebrex did not show evidence of increased cardiac risk when approved, under a year later a Vioxx study found the drug was five times more likely than naproxen to cause heart attacks. A study was recently halted because Celebrex was shown to have similar risks, but Celebrex has so far not been recalled.

Wolfe believes "removing Celebrex from the market will be a major step forward for public health."

For more information on the Celebrex ban, please contact us to confer with a Celebrex Lawyer and learn your legal rights and options.

 

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