FDA advisory panel votes to keep COX-2s on market
Following three days of hearings last week, an FDA panel determined Friday that the COX-2 painkillers Vioxx, Celebrex and Bextra should stay on the market despite posing certain cardiovascular risks.
The panel agreed unanimously that COX-2s significantly increase the risk of heart attack or stroke but they also appeared to determine that the benefits of Vioxx, Celebrex and Bextra outweighed their risks, according to published reports.
During the hearings, Merck research head Peter Kim hinted his company might consider returning Vioxx to the market if the advisory committee and the FDA conclude that the benefits of the class outweigh the risks.
"Then we would have to consider the implications of these new data," he said.
The advisory group recommended continued use of Merck's Vioxx by a narrow vote of 17-15. The panel voted for continued use of Pfizer's Celebrex by a vote of 31-1 and continued use of Pfizer's painkiller Bextra by a vote of 17-13, with two abstentions.
Panel members also strongly recommended the inclusion of "black box" labeling on all three drugs, warning of their heightened heart risks.
And the panel discussed considering similar warnings for all non-steroidal anti-inflammatory (NSAIDs) drugs.
The panel's decisions will be forwarded to the FDA for final action. Although it is not required, the FDA usually follows the advice of its advisory panels.
As the hearings began last Wednesday, Steven Galson, acting director of the FDA's Center for Drug Evaluation and Research, promised prompt action by the agency.
He said the FDA would make its decision about the future of COX-2s in the next few weeks.