FDA says it will investigate potential heart risks of hypertension drug Benicar

The Food and Drug Administration said Friday that it will investigate the possible increased risk of heart attacks, stroke or sudden deaths in patients taking the antihypertension drug Benicar, known generically as olmesartan. The agency said it is not yet sure that the drug presents a risk and that current evidence indicates the benefits outweigh any potential risk.

Benicar is a member of a class of drugs called angiotensin receptor blockers, a family that includes Cozaar and Diovan.

The FDA said it is evaluating data from two clinical trials in which patients were taking either Benicar or a palcebo in a study to determine whether the drug would slow the progression of kidney disease. Both trials unexpectedly showed a higher number of deaths from heart attacks and strokes among patients taking the drug.

The agency encouraged patients and physicians to report any adverse events associated with the drug.

—Thomas H. Maugh II
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