Vioxx-type drugs may not have same risk - regulator

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Pain relievers in the same class as Vioxx may not carry the same cardiovascular risk as the blockbuster drug that was withdrawn from the market three weeks ago, a U.S. regulator said on Wednesday.

Vioxx is a COX-2 inhibitor, a class of drugs that includes Celebrex and Bextra, made by Pfizer Inc., as well as Arcoxia, the second-generation pain reliever made by Vioxx maker Merck, which is under regulatory review.

"What I can say is that we believe (COX-2 drugs) are as diverse as the statin drugs,” acting U.S. Food and Drug Administration Commissioner Lester Crawford said after addressing a group at the Cleveland Clinic.

Crawford’s cautious comment reiterated that of another FDA official who said earlier this week that there was no definitive evidence that all COX-2 inhibitors carried Vioxx’s risk of causing heart attacks and strokes.

Merck withdrew Vioxx three weeks ago after a clinical trial showed it doubled the risk of heart attack and stroke after 18 months of use compared with a placebo.

Crawford declined to comment on Arcoxia and whether FDA will require additional data for it to gain U.S. approval.

Vioxx, which had $2.55 billion in annual sales, was often prescribed for arthritis sufferers and touted as less harmful to the stomach than other pain relievers.

Some experts have posed the possibility that all COX-2 inhibitors could cause heart risk by acting on the epithelium that lines blood vessels.

Pfizer CEO Hank McKinnell said in an interview on Wednesday that preliminary signs point to Celebrex being protective of the heart, not harmful.

“Part of our clinical plan for Celebrex is to compare it to placebos in high-risk patients, and our hope is that they will prove that it, like aspirin, is protective for the heart, not damaging for the heart,” McKinnell told Reuters in Kampala, Uganda.

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