FDA Drug Safety Communication

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FDA Date: 6/10/10

Benicar (olmesartan) FDA Drug Safety Communication

Ongoing Safety Review of Benicar and Cardiovascular Events

FDA is evaluating data from two clinical trials in which patients with type 2 diabetes taking the blood pressure medication Benicar (olmesartan) had a higher rate of death from a cardiovascular cause compared to patients taking a placebo. Benicar is also sold in combination with hydrocholorothiazide as Benicar HCT for the treatment of high blood pressure.

FDA review is ongoing and the Agency has not concluded that Benicar increases the risk of death. FDA currently believes that the benefits of Benicar in patients with high blood pressure continue to outweigh its potential risks. Healthcare Professionals should follow the recommendations in the drug label when prescribing Benicar. The Agency plans to review the primary data from the two studies of concern, ROADMAP and ORIENT, and is considering additional ways to assess the cardiovascular effects of Benicar.

This communication is in keeping with the FDA commitment to inform the public about its ongoing safety review of drugs. The Agency will update the public when this review is complete.

View the full FDA Drug Safety Communication on FDA.gov