FDA Drug Safety Communication

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FDA Date: 6/23/14

Olmesartan FDA Drug Safety Communication

FDA review of cardiovascular risks for diabetics taking hypertension drug olmesartan not conclusive; label updates required This information is in follow-up to the FDA Drug Safety Communication: Safety Review Update of Benicar (olmesartan) and cardiovascular events.

The U.S. Food and Drug Administration (FDA) has completed its safety review and has found no clear evidence of increased cardiovascular risks associated with use of the blood pressure medication olmesartan in diabetic patients. As a result, our recommendations for use of olmesartan (Benicar, Benicar HCT, Azor, Tribenzor, and generics) will remain the same, but we will require information about some of the studies to be included in the drug labels. Patients should discuss any questions they have with their health care professionals.

It is important to take olmesartan and other blood pressure medicines because uncontrolled high blood pressure increases the risks of cardiovascular problems such as heart disease and stroke, as well as kidney failure and other health problems. Do not stop taking olmesartan or any blood pressure medication without first discussing it with your health care professional.

This safety review was prompted by the results of the ROADMAP trial. The ROADMAP (Randomized Olmesartan and Diabetes Microalbuminuria Prevention) clinical trial examined the effects of olmesartan in patients with type 2 diabetes, to see whether olmesartan could delay kidney damage. There was an unexpected finding of increased risk of cardiovascular death in the olmesartan group compared to the group taking a placebo, or sugar pill. However, the risk of non-fatal heart attack was lower in the olmesartan-treated patients.

To evaluate these findings, we reviewed additional studies, including a large study in Medicare patients. While data from the ROADMAP trial and the Medicare study have suggested that high-dose olmesartan may increase cardiovascular risk in diabetic patients, when considering the data from all trials and studies, they are not conclusive. Overall, we have determined that these studies do not clearly show 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.

Olmesartan is a type of blood pressure medicine called an angiotensin receptor blocker, or ARB. In 2013, there were approximately 1.8 million patients who received a dispensed prescription for olmesartan-containing products from U.S. outpatient retail pharmacies.

FDA posted two previous Drug Safety Communications (DSCs) on this issue. The first, in June 2010, described the ongoing review of olmesartan and cardiovascular events. The second was a DSC update in April 2011.

View the full FDA Drug Safety Communication on FDA.gov