Fda approval surprises many doctors
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Posted on Tue, Feb. 22, 2005
FDA’s refusal to ban COX-2 inhibitors surprises many doctors
By Delthia Ricks
In the past decade, the public has seen a series of high-profile drugs designed to treat everything from diabetes to heartburn banished from the market, and it was widely believed early last week that the painkillers called COX-2 inhibitors would succumb to the same fate.
But when two Food and Drug Administration panels narrowly voted Friday to allow Vioxx to make a comeback – and for Celebrex and Bextra to remain on pharmacy shelves – many doctors and health care activists responded to the decision with shock.
Just days before the vote, a flurry of medical studies demonstrated that each of the medications was inherently dangerous, capable of raising the risk of heart attacks, strokes and a wide range of other cardiovascular problems.
Dr. Jeffrey Drazen, editor of the New England Journal of Medicine, wrote in a blistering editorial that perhaps it was time to end the problematic pharmaceutical run of the drug class called COX-2. Nevertheless, proponents who pleaded with FDA panelists to keep the drugs spoke of patients who need them to beat back chronic pain.
Dr. Mark Fendrick, a professor of medicine at the University of Michigan, said that despite the controversy, judicious use can help sidestep potential dangers. “Now that the FDA panel has noted the potential for all COX-2 inhibitors to increase the risk of adverse cardiovascular events, their use should be limited to individuals at risk for stomach injury and those who are at low risk for cardiac problems.”
COX-2 inhibitors, initially dubbed super-aspirin, prevent the stomach ulceration associated with aspirin. Critics Friday were less diplomatic, charging that the drugs entered the market on fast-track approvals based on small industry-run studies that were not strong enough to spot the dangers that have unfolded.