July 5, 2013
FDA has approved labeling changes for all olmesartan medoxomil products to include a warning about intestinal problems known as sprue-like enteropathy. Olmesartan medoxomil is an angiotensin II receptor blocker (ARB) used to treat high blood pressure. It is marketed as a single agent under the trade name Benicar® and also in fixed combinations under the trade names Benicar HCT®, Azor®, and Tribenzor®. Generic olmesartan medoxomil products are also available.
FDA evaluated multiple data sources and concluded there was an association between olmesartan use and sprue-like enteropathy. The exact mechanism for sprue-like enteropathy with olmesartan medoxomil is unknown. Olmesartan medoxomil is 1 of 8 ARB drugs available in the United States. Sprue-like enteropathy has not been associated with any of the other drugs in the ARB class. For a summary of the data reviewed by FDA, see the Safety Announcement link below.
Sprue-like enteropathy symptoms include severe, chronic diarrhea and weight loss, and may result in hospitalization. These symptoms can develop months to years after therapy is initiated. Evaluate any patient taking olmesartan medoxomil who develops these symptoms for other possible causes, such as celiac disease. If other etiologies have been ruled out, discontinue olmesartan medoxomil and start a different antihypertensive therapy. Sprue-like enteropathy symptoms have shown improvement in all cases after discontinuation of olmesartan medoxomil.
The safety of olmesartan medoxomil and products containing this active ingredient will continue to be evaluated by FDA. Patients are advised to contact their health care professional immediately if they experience severe, chronic diarrhea or significant weight loss and are taking olmesartan medoxomil or any medication containing this active ingredient. Patients should not stop taking prescribed blood pressure medications without first consulting their healthcare provider.
Report any related adverse events to FDA’s MedWatch Adverse Event Reporting program online (www.fda.gov/MedWatch/report.htm). Forms are also available by calling 800-332-1088.
Additional information is available at the following links:
- MedWatch Alert:
- Safety Announcement:
July 5, 2013; University of Utah, Drug Information Service. Copyright 2013, Drug Information Service, University of Utah, Salt Lake City, UT.