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FDA orders Celebrex black box warnings

August 2, 2005

The U.S. Food and Drug Administration finalized a new "black box" label for Pfizer Inc.'s arthritis painkiller Celebrex to warn of increased risks of heart attacks and strokes. A black box warning is the strictest FDA issued drug warning short of a recall, and the Celebrex warnings are similar to ones that will also be added to older painkillers like ibuprofen and naproxen.

Celebrex belongs to the class of drugs called Cox-2 inhibitors. The only Cox-2 now on sale in the U.S., Pfizer's similar Cox-2 drug Bextra was recalled in April over safety concerns, and Merck & Co.'s Cox-2 Vioxx was recalled last September after studies showed it doubled the risks of heart attacks and strokes.

The new Celebrex label will recommend the drug be prescribed at the lowest dose and shortest time possible. The label will also carry a safety warning that the drug should not be used to treat pain associated with heart bypass surgery.

Scrutiny over the safety of Cox-2 drugs following the Vioxx recall raised serious questions about drug company practices and federal regulation of drugs already on the market. Both Pfizer and Merck have been the target of great criticism for their failure to implement earlier safety warnings, and Merck is currently in the midst of what could be potentially very damaging litigation related to the Vioxx recall.

Sales of Celebrex have suffered as a result of the Cox-2 controversy. Compared to the second quarter last year, Celebrex has seen a decrease in the second quarter of 45 percent in sales to $401 million.

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

 

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