Olmesartan passes safety review

The benefits of the angiotensin-receptor blocker olmesartan (Benicar, Benicar HCT, Azor, Tribenzor) continue to outweigh the risks for diabetic patients, according to a recently concluded FDA safety review.

The agency chose to review the drug after a placebo-controlled clinical trial of olmesartan in patients with type 2 diabetes showed an unexpected finding of increased risk of cardiovascular death in patients taking the drug. After reviewing additional studies, including a large one of Medicare patients, the agency found a suggestion that high-dose olmesartan may increase cardiovascular risk in diabetic patients, but no conclusive evidence. Overall, the FDA determined that the studies do not clearly show an increased cardiovascular risk and do not support changing recommendations for olmesartan use.

The agency will, however, require information about some of the studies to be included in the drug labels, according to a drug safety communication.