FDA mandates "black box" for Celebrex, pulls Bextra off market

April 7, 2005

Drug giant Pfizer’s two blockbuster Cox-2 inhibitor drugs, Celebrex and Bextra, were both cited by the Food and Drug Administration for safety problems, particularly for long term users.

Last Thursday the FDA allowed Pfizer to keep Celebrex on the market if it added the “black box” warning to the physicians’ guideline. This warning is the strongest the FDA can give to doctors, and focuses on the increased chances of cardiovascular problems and gastrointestinal bleeding. Doctors should use the lowest possible dosage of Celebrex and for the shortest time necessary, it adds.

Meanwhile, Bextra was taken off the market today. Bextra users were told to stop taking the drug, according to reports.

Pfizer agreed to mandates by a blue ribbon panel of specialists, convened in February, to review the risks associated with the popular Cox-2 class of painkillers. The pills are taken by 50 million people worldwide.

The actions by the FDA are attributed to charges the agency was too slow and allowed manufacturers to report problems voluntarily. It also comes as other experimental Cox-2 drugs emerge, such as Merck’s Arcoxia and Novartis’s Prexige, and seems to raise the requirements for their future approval.

Critics said the Cox-2 inhibitors were over-prescribed and offered no more relief than cheaper over the counter medications such as ibuprofen.

Pfizer Inc (NYSE Symbol PFE) was trading at 26.90 at close on Thursday, up 0.15%