HEALTH

FDA ponders future for Cox-2 drugs

Lack of data on older NSAIDs proves a stumbling block for a panel intent on sorting through pain medication.

By Susan J. Landers, AMNews staff. March 14, 2005.

Washington -- With the cardiovascular risks of the painkillers Vioxx, Celebrex and Bextra emphatically recognized by a Food and Drug Administration advisory panel meeting in February, many panelists expressed additional concern that physicians and patients might turn too quickly to some older pain relievers without careful assessment of their potential dangers.

"We are worried about some of the other NSAIDs, and I hope that message came through," said Steve Nissen, MD, medical director of the Cleveland Clinic's Cardiovascular Coordinating Center, and a FDA advisory panel member.

"Some of the [older nonsteroidal anti-inflammatory drugs] are relatively Cox-2 specific," he noted. For example, "We aren't so sure that agents like diclofenac and Mobic don't have the same [cardiovascular] risks. And we're not so sure about ibuprofen, either."

The FDA panel met for three days to grapple with the safety issues that surfaced when Merck voluntarily withdrew its Cox-2 selective NSAID Vioxx (rofecoxib) from the market because of increased cardiovascular risk. The panel also discussed the benefits of pain drugs long on the market, some available over the counter and in generic form.

The panel ultimately did vote that Celebrex (celecoxib) and Bextra (valdecoxib) should remain on the market despite associated cardiovascular risks and also opened the door for the possible return of Vioxx. But the vote was close in regard to Vioxx and Bextra.

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