FDA Warns on Pain Pill Use

The FDA said that although recent tests showing cardiovascular risk for Celebrex, Bextra and naproxen conflict with other results from other studies of the same drugs, the agency said it was best to act until these tests are studied in greater detail.

For example, one test released Friday showed patients taking Celebrex had a higher risk of cardiovascular problems than did patients taking a placebo. But two other tests showed no increased risk of cardiovascular damage among Celebrex patients.

In addition, one recent test showed patients taking a combination of Bextra and an experimental pain drug had a greater risk of heart problems compared to patients taking a placebo. This test examined patients who had undergone heart bypass surgery. Bextra is not permitted for any post-surgical care in the U.S.

However, another test of heart bypass surgery patients showed no statistically significant risk for cardiovascular problems among patients taking Bextra alone vs. patients receiving placebo. And in a third test involving general surgery patients, Bextra plus the experimental painkiller posed no additional risk.

On Monday, a clinical trial comparing patients who took Celebrex or naproxen vs. patients taking a placebo demonstrated no cardiovascular risk for Celebrex but an increased risk for naproxen.

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