FDA panel: Celebrex risky, but marketing in U.S. OK

| 2/18/2005

An FDA committee has concluded that the drug Celebrex significantly increases the risk of cardiovascular events such as heart attack or stroke.

However, the same committee concluded that the benefits of the drug were great enough to outweigh the risks, and said the agency should allow it to be marketed in the United States.

Celebrex came into the national spotlight in 2004, when the drug’s maker announced the results of two recent studies of the painkiller.

“One of the studies demonstrated an increased cardiovascular risk over placebo,” Pfizer, the company that produces Celebrex, said in a statement, “while the other trial revealed no greater cardiovascular risk than placebo.”

Although Pfizer stands by the safety of the drug – and only one of three recent studies shows an increased risk for those using the drug – The New York Times reported that the company has pulled all advertising of the painkiller.

The drug took another hit in December 2004, when the National Institutes of Health announced it had halted a study that included naproxen – known by the brand name Aleve – and celecoxib – known by the brand name Celebrex.

The study, a national trial looking at ways to prevent Alzheimer’s disease, was sponsored by the National Institute on Aging, which is part of the National Institutes of Health. While that study raised some concerns about naproxen, it did not show a similar increase in cardiac problems with the use of Celebrex. But the publicity was nonetheless damaging, coming in the wake of the earlier study.

The FDA committee was still meeting at press time Friday; further results of the meeting were not available.