Celebrex label revised yet again

Pfizer changes Celebrex label to recommend prescribing at lowest effective dose

08/01/05

Pfizer, Inc., maker of the arthritis drugs Celebrex and Bextra, COX-2 inhibitors linked to dangerous cardiovascular side effects, announced today that it has revised the warning label on Celebrex to include a prominent warning of possible cardiovascular risks. The new label warns of increased risk of heart attack, stroke and sudden cardiac death in patients using Celebrex. Celebrex is the only COX-2 inhibiting pain reliever to remain on the market after recalls of Vioxx and Bextra, two drugs that work in similar fashion to control severe pain.

Vioxx and Bextra have both been recalled by the U.S. Food and Drug Administration for dangerous side effect risks that outweigh the possible benefits of taking the drugs.

A federal advisory panel of doctors in February aid that Celebrex “significantly” raised the risk of heart problems and strokes in patients taking it. The FDA feels that the benefits outweigh those risks at this time. Although the largest clinical trial of Celebrex failed to show that the drug reduced gastro-intestinal side effects more than conventional arthritis pain relievers like acetaminophen and ibuprofen, Pfizer has continued to widely advertise and promote Celebrex as a remedy for arthritis pain.

Source: “Pfizer’s Celebrex arthritis drug to add warning,” Reuters, August 1, 2005.

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