FDA clears olmesartan after safety review

The FDA supported the use of the blood pressure medication olmesartan in patients with diabetes after determining that its benefits outweigh potential risks.

The agency conducted a safety review after the ROADMAP (Randomized Olmesartan and Diabetes Microalbuminuria Prevention) clinical trial signaled an increased risk of cardiovascular death in patients treated with olmesartan compared with placebo. The trial was designed to evaluate the use of olmesartan as a way to delay kidney damage in patients with type 2 diabetes.

The FDA reviewed ROADMAP data as well as a large study that enrolled Medicare patients and found no clear evidence of increased cardiovascular risks. It recommended patients continue treatment with olmesartan or other blood pressure medications, and it is requiring some study data to appear in labeling.

The FDA’s notice includes the brands Benicar, Benicar HCT, Azor, Tribenzor and their generics.