FDA panel clears way for Vioxx

WASHINGTON – Even though popular arthritis painkillers Vioxx, Celebrex and Bextra increase the risk of heart attack and stroke, they should be allowed to be sold to the public with strong risk warnings attached because they’re effective, a Food and Drug Administration advisory panel said Friday.

The full FDA isn’t required to go along with the panel’s recommendation but is expected to give it great weight. FDA officials said the agency would act within weeks.

The panel was nearly unanimous in recommending the continued sale of Celebrex but was divided on Bextra and Vioxx. Studies show both drugs were riskier.

Merck & Co. withdrew Vioxx from the market Sept. 30, citing studies pointing to cardiovascular risk, but the company said Thursday that it might begin marketing Vioxx again based on appeals from patients and new study results. Pfizer, the manufacturer of Bextra and Celebrex, still sells the medications, despite similar safety concerns.

The FDA panel’s ruling was a turnabout of fortune for a class of drugs called Cox-2 inhibitors that has been under a cloud for months.

Vioxx troubled panel members most.

“I think the data here are very compelling. There is a clear signal that this drug (Vioxx) appears substantially worse than the others,” said Dr. Alastair Wood of the Vanderbilt University School of Medicine.