Bextra off the market in U.S. after federal request

| 4/7/2005

The federal Food and Drug Administration has asked Pfizer Inc., the maker of the painkiller Bextra, to pull the drug from the market in this country. The company has agreed.

Bextra is designed to treat joint pain, inflammation and stiffness associated with illnesses such as arthritis.

In a health advisory issued this week, the FDA said it had concluded “that the overall risk vs. benefit profile is unfavorable” – essentially, that the risks of taking Bextra now outweigh the benefits.

Those risks include possible cardiovascular problems and “potentially life-threatening skin reactions,” according to the advisory. In part, FDA officials said they did not have enough data on how long-term use of Bextra could affect the heart, and referred to an “increased risk of adverse CV events in short-term coronary artery bypass surgery trials that FDA believes may be relevant to chronic use.”

The FDA recommended that patients who are now taking Bextra should contact their physicians and consider alternative treatments.

Other warnings
In addition, the FDA has asked all other companies that make similar drugs – called COX-2 non-steroidal anti-inflammatory drugs – to revise the labels of their drugs to include a warning about possible serious side-effects, including cardiovascular problems and gastrointestinal bleeding.

The agency’s health advisory said the drugs in the second warning included the popular pain medication Celebrex, also made by Pfizer Inc. Other warnings are being ordered for over-the-counter painkillers that contain ibruprofen, a group that includes the popular drug Advil.

Since mid-2004, the agency and other scientists have issued a series of warnings about prescription and over-the-counter painkillers.

Merck announced Sept. 30, 2004, that it would pull the popular arthritis and pain medicine Vioxx off the market worldwide after a study determined it could cause an increased risk of heart attack and stroke.

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

Then, in November 2004, Pennsylvania scientist Garret A. Fitzgerald told a conference of the American Heart Association that the painkiller Bextra could pose an even greater risk of heart attack or stroke than Vioxx.

That was followed by an FDA announcement that the agency would require a boxed warning label on bottles of Bextra strengthening previous warnings about the risk of “life-threatening skin reactions.” The warnings added at that time also recommended that coronary artery bypass patients avoid the drug.

Then, on Dec. 20, 2004, the National Institutes of Health announced it had halted a national trial looking at ways to prevent Alzheimer’s disease that included naproxen – known by the brand name Aleve – and celecoxib – known by the brand name Celebrex.

“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.

The FDA 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.”

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.

--by Mark H. Reddig, associate editor