FDA: No evidence olmesartan increases CV risks for diabetes patients

June 25, 2014

FDA’s review of the hypertension drug olmesartan found no clear evidence of increased heart risks for diabetes patients, but the agency will require additional information be provided on the drug’s labels.

FDA’s review of the hypertension drug olmesartan found no clear evidence of increased heart risks for diabetes patients, but the agency will require additional information be provided on the drug’s labels.

Olmesartan is sold under the brand names Benicar, Benicar HCT, Azor, and Tribenzor. It is also sold in generic forms.

In its safety communication, FDA said its review of cardiovascular risks for diabetics taking olmesartan is not conclusive, but the agency said it will require information about some of the studies to be included on the drug’s labels. FDA’s recommendations for the use of the drug and its generics will remain the same.

FDA said its review was prompted by a clinical trial that evaluated the effects of olmesartan in patients with type 2 diabetes. That trial found an increased risk of cardiovascular death in patients using olmesartan versus those receiving placebos.

However, FDA said it reviewed additional studies and determined that, overall, the studies did not find an increased cardiovascular risk.

“Thus, the collective evidence available at this time does not support changing our recommendations for olmesartan use and does not support recommending that its use be avoided in patients with diabetes,” FDA wrote.