FDA Finds No Clear Evidence of Increased Heart Risks for Diabetics Taking Olmesartan

The Food and Drug Administration June 24 said it has completed its safety review and has found no clear evidence of increased cardiovascular risks associated with the use of the blood pressure medication olmesartan in diabetic patients.

The agency said that its recommendations for the use of olmesartan will remain the same, but it will require information about some of the studies on cardiovascular risks to be included in the drug labels. Daiichi Sankyo Inc. manufactures the brand versions of olmesartan, which include Benicar, Benicar HCT, Azor and Tribenzor.

The FDA’s safety review was prompted by the results of a ...