FDA Panel Members: All Arthritis Drugs Suspect
Experts to Vote on Possible Restrictions
Arcoxia, which is stalled at the FDA because of Cox-2 safety concerns, appeared to show a "trend" toward raised heart and stroke risk, said FDA safety officer Joel Schiffenbauer, MD.
Cox-2 drugs and related anti-inflammatory drugs all fell under suspicion last fall when data emerged showing that Vioxx roughly doubled the risk of heart attacks and strokes in patients who took it. Several other studies have come to light, some showing increased risks with related drugs and others suggesting no safety concerns.
Millions of patients have come to rely on Cox-2 drugs for arthritis pain, and many doctors favor their use because they cause less stomach bleeding than older drugs like ibuprofen.
FDA regulators convened the three-day inquiry in an effort to find a path toward deciding if a risk of heart attack and stroke applies to a wide group of pain drugs and if so, whether the danger justifies the benefits of Cox-2 and related drugs.
Several arthritis patients and doctors attended an open session urging experts to be cautious before recommending tight restrictions or a ban on Cox-2 use.
"I feel like Celebrex was created for me. Most days I feel better than I did 30 years ago," said Judy Fogel, an
patient from Ithaca, N.Y.
Betsy Chaney, another Celebrex user, told panelists that she wanted to keep the right to use the drug despite possible heart dangers. "I'm willing, for my quality of life, to take those risks," she said.
One doctor pointed out that researchers and regulators have known of potential Cox-2 risks since February 2001 when an FDA advisory panel similar to the one meeting this week heard evidence that the drugs can raise the risk of dangerous heart problems.
"The question before us is did American doctors prescribe $7 billion worth of Vioxx after Merck and the FDA knew" of the risks, said John Abramson, a family physician from Harvard University.