FDA: Benefits of Olmesartan Outweigh Potential Risk for Cardiovascular Death

The benefits of olmesartan (Benicar) "continue to outweigh its potential risks when used for the treatment of patients with high blood pressure according to the drug label," the FDA announced on Thursday.

The agency began a safety review of the angiotensin-receptor blocker in June 2010 after two studies showed a higher rate of cardiovascular death among patients taking olmesartan, compared with those taking placebo; the trials aimed to show whether olmesartan would slow progression of kidney disease in patients with diabetes. In its update on Thursday, the FDA cautions against using olmesartan to delay or prevent microalbuminuria in patients with diabetes.

The agency advises that clinicians "follow the recommendations in the drug label" when prescribing the drug. The manufacturer has agreed to conduct further studies on olmesartan's cardiovascular risk profile.