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FDA Requires Label Updates for Hypertension Drug Olmesartan, Review of Heart Risks in Diabetics Inconclusive

Jun 25, 2014

In a Drug Safety Communication issued Tuesday, the U.S. Food and Drug Administration (FDA) said that upon completing its safety review of the blood pressure medication olmesartan it did not find conclusive evidence of increased cardiovascular risks in diabetic patients. In light of this, the agency is not changing recommendations for the drug’s use but will require information from these studies to be included on the labels. Olmesartan is sold under the names Benicar, Benicar HCT, Azor, Tribenzor and generics.

The FDA advised patients to speak with their healthcare professionals if they have any questions. Olmesartan patients should not stop taking the medication without speaking with their doctor first. Olmesartan and other hypertension drugs can play a crucial role in treatment because uncontrolled high blood pressure raises the likelihood of cardiovascular risks, such as heart disease, stroke and kidney failure.

Olmesartan belongs to a class of blood pressure drugs called angiotensin receptor blockers, or ARBs. About 1.8 million patients received a dispensed prescription for a product containing this drug in 2013.

The agency reviewed the drug based on the results of the ROADMAP (RandomizedOlmesartan and Diabetes Microalbuminuria Prevention) trial. The clinical trial aimed to see whether or not olmesartan could help reduce the risk of kidney damage. Instead, researchers found that the olmesartan group had a higher risk of cardiovascular death compared to placebo. However, this group also had a lower risk of non-fatal heart attacks.

The FDA looked at additional studies to evaluate the cardiovascular risks in diabetic patients taking olmesartan. The review included a large study of Medicare patients, according to the Safety Announcement. The agency found that overall the findings from the studies did not clearly shown a higher risk of cardiovascular events.

Two Drug Safety Communications have been issued in the past. In June 2010, the FDA cited data suggesting a higher risk of cardiovascular death in the olmesartan group during the ROADMAP trial. At the time, the agency did not draw any conclusions and described an ongoing review. The agency issued a Drug Safety Communication update in April 2011.

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