The Food and Drug Administration asked a panel of advisers to consider what safety information is needed to allow continued sales of Pfizer Inc.’s Celebrex painkiller and the introduction of similar drugs in the U.S.
The FDA posted on its Web site Friday reports intended to prepare doctors and researchers for a Feb. 16-18 meeting on painkiller safety. The agency called the meeting after a Merck & Co. study linked its Vioxx painkiller to risk of heart attacks and strokes, leading to the biggest drug withdrawal ever.
The FDA staff asked advisers to the agency to consider whether drugs similar to Vioxx–including Celebrex, Merck’s Arcoxia and Novartis AG’s Prexige–may pose the same risk. The medicines were designed to target the Cox-2 enzyme, linked to pain.
Among reports the FDA posted on its Web site was one saying that Arcoxia may have a “safety signal” for cardiovascular risk while offering “limited” benefit for the stomach. Another report said a study of Novartis’s Prexige “had not definitively answered the question” of whether it poses more of a heart risk than older painkillers.
