Consumer Lawyers

FDA Adds GI Warning to Benicar Label

In FDA Warning on July 6, 2013 at 12:28 am

The FDA ordered the maker of the blood pressure drug olmesartan (Benicar) to add a warning about the risk of an intestinal condition known as sprue-like enteropathy to the drug’s label.

The connection between sprue-like enteropathy and olmesartan was first reported in June 2012 by Mayo Clinic researchers who, from 2008-2010, had seen 22 patients with symptoms suggestive of celiac disease but antibody blood tests that did not support the diagnosis.

Later in October 2012, researchers at the American College of Gastroenterology meeting noted that olmesartan, an angiotensin II receptor blocker, or ARB, had been linked to another 40 such cases of sprue-like enteropathy.

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