FDA Drug Safety Communication

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FDA Date: 4/13/11

FDA Drug Safety Communication for Benicar (olmesartan)

Safety Review Update of Benicar (olmesartan) and Cardiovascular Events

FDA has finished reviewing the results of the ROADMAP and ORIENT trials,and has determined that the benefits of Benicar continue to outweigh its potential risks when used for the treatment of patients with high blood pressure according to the drug label. Benicar is not recommended as a treatment to delay or prevent protein in the urine (microalbuminuria) in diabetic patients.

Daiichi Sankyo, the makers of Benicar, have agreed to work with the FDA to perform additional studies, as well as conduct additional analyses of completed clinical studies, to obtain more complete information about the cardiovascular risks or benefits of Benicar in various clinical settings. FDA will update the public when new information is available.

View the full FDA Drug Safety Communication on FDA.gov