Concerns raised about Celebrex, Aleve

| Tuesday, December 21, 2004

Two more popular painkillers are in the public spotlight after reports surfaced about possible links to cardiac problems.

Neither of the two painkillers, Celebrex and Aleve, have been pulled from the market. News of possible cardiac problems follow similar concerns about Bextra, which will now carry a warning label, and Vioxx, which has been pulled from the market.

The National Institutes of Health announced Dec. 20 that 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.

“Data from the … trial indicated an apparent increase in cardiovascular and cerebrovascular events among the participants taking naproxen when compared with those on placebo,” according to an Institutes statement.

“This step is being taken as a precautionary measure to ensure the safety of the study’s participants,” Dr. Elias A. Zerhouni, director of the National Institutes of Health, said in a statement. “The investigators made their decision based on the risk/benefit analysis specific to this trial.”

The federal Food and Drug Administration quickly followed the National Institutes announcement, issuing a warning about the popular painkiller.

“The Food and Drug Administration is working with the National Institutes of Health to review the available scientific information on naproxen,” the statement read. “In the meantime, FDA advises patients who are currently taking over-the-counter naproxen products to carefully follow the instructions on the label. Patients should not exceed the recommended doses for naproxen (220 milligrams twice daily) and should not take naproxen for longer than ten days unless a physician directs otherwise.”

The Institutes’ study did not show a similar increase in cardiac problems with the use of Celebrex. However, concerns had already been raised regarding that drug in one of two recent studies.

“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 current flood of painkiller concerns follows action by the FDA, which announced recently it would require a warning label on bottles of Bextra, a prescription drug designed to treat joint pain, inflammation and stiffness associated with illnesses such as arthritis.

The new “boxed” warning will strengthen previous warnings about the risk of “life-threatening skin reactions” and also warn patients who are undergoing coronary artery bypass graft surgery to avoid the drug.

The FDA noted in a “talking paper” that a study conducted by Pfizer, the maker of Bextra, showed an “increased cardiovascular risk,” including higher numbers of heart attacks, strokes and other coronary events in bypass patients who used the drug after surgery.

Merck, the maker of Vioxx, pulled that popular arthritis and pain medicine off the market worldwide in September after a study determined it could cause an increased risk of heart attack and stroke.

The problems with Vioxx showed up in some patients starting 18 months after receiving treatment with the drug, Merck officials said. Vioxx has been on the market in the United States since 1999 and was marketed in more than 80 countries.

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