FDA reviews cardiovascular mortality risk associated with Benicar

The FDA is evaluating data from two clinical trials in which patients with type 2 diabetes taking Benicar (olmesartan medoxomil tablets, from Daiichi Sankyo) had a higher rate of death from a cardiovascular cause compared to patients taking a placebo. In both the ROADMAP and ORIENT trials, patients with type 2 diabetes were given either Benicar or placebo to determine if treatment with Benicar would slow the progression of kidney disease. An unexpected finding observed in both trials was a greater number of deaths from a cardiovascular cause (eg, myocardial infarction, sudden death, or stroke) in the Benicar-treated patients compared to placebo.

The FDA’s review is ongoing. It has not been concluded that Benicar increases the risk of death. The FDA currently believes that the benefits of Benicar in patients with high blood pressure continue to outweigh its potential risks. Patients are advised to continue taking their medication unless instructed otherwise by their healthcare provider.

Benicar is an angiotensin II receptor blocker indicated for the management of hypertension.

For more information visit www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm215249.htm.