FDA Panel Members: All Arthritis Drugs Suspect
Experts to Vote on Possible Restrictions
"I think that there is a signal [of risk] probably for all of these drugs. There may be different mechanisms, but each of these drugs is suspect," said Steven Abramson, MD, a professor of rheumatology at the New York University School of Medicine and another committee member.
FDA officials also told experts that a one-year study of patients taking Prexige showed that they had a 44% greater risk of probable heart attacks, strokes, or death than patients who took the widely used anti-inflammatory drug naproxen. The FDA rejected Novartis' bid to market the drug in the fall of 2003.
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.