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FDA Alert for Cardiac drug
New FDA Medwatch Alert
Sent to subscribers of: olmesartan systemic, olmesartan
Drug Safety Communication: Olmesartan Medoxomil - Label Changes To Include Intestinal Problems (Sprue-Like Enteropathy)
July 3, 2013
Audience: Health Professional, Cardiology, Patient.
ISSUE: FDA is warning that the blood pressure drug Olmesartan Medoxomil (marketed as Benicar, Benicar HCT, Azor, Tribenzor, and generics) can cause intestinal problems known as sprue-like enteropathy. Symptoms of sprue-like enteropathy include severe, chronic diarrhea with substantial weight loss. FDA has approved changes to the labels of these drugs to include this concern. Sprue-like enteropathy has not been detected with ARB drugs other than olmesartan. Read more.
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