Safety Alerts & Recalls

What does this mean?

The FDA review of this new study data for Benicar is ongoing and the FDA will update the public with its conclusion after reviewing all of the available safety data for Benicar. At this time, the FDA believes the benefits of Benicar in patients with high blood pressure continue to outweigh the potential risks. If you take Benicar, Benicar HCT, or Azor, do not stop your treatment unless told to do so by your healthcare professional. Please talk to your healthcare professional if you have concerns about Benicar, Benicar HCT, or Azor.

The U.S. Food and Drug Administration (FDA) Announces Ongoing Safety Review of Benicar and Risk of Heart Attack, Sudden Death, and Stroke

The FDA is evaluating data from two clinical research studies in which patients with type 2 diabetes taking the blood pressure medication Benicar (olmesartan) had a higher rate of death from the cardiovascular events of heart attack, sudden death, or stroke compared to patients taking a placebo. Benicar is an angiotensin II receptor blocker (ARB) used to treat high blood pressure. It contains the active ingredient olmesartan. Benicar is also sold in combination with hydrocholorothiazide as Benicar HCT and in combination with amolodipine (Norvasc) under the brand name Azor.

The FDA's review is ongoing and the FDA has not concluded that Benicar increases the risk of death. Other controlled clinical studies evaluating Benicar and medicines like it have not suggested an increased risk of death from heart attack, sudden death, or stroke.

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Source: FDA
Publication Date: 2010-06-11
Last Updated: 2010-06-11

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