FDA: Olmesartan Linked to Intestinal Disorder

BENICAR (olmesartan medoxomil) 5mg, 20mg, 40mg tablets by Daiichi Sankyo
BENICAR (olmesartan medoxomil) 5mg, 20mg, 40mg tablets by Daiichi Sankyo

The FDA is warning that the antihypertensive Olmesartan Medoxomil can cause intestinal problems known as sprue-like enteropathy.

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Olmesartan Medoxomil is an angiotensin II receptor blocker (ARB) marketed as Daiichi-Sankyo's Benicar (olmesartan medoxomil), Benicar HCT (olmesartan medoxomil, hydrochlorothiazide), Azor (amlodipine, olmesartan medoxomil), and Tribenzor (olmesartan medoxomil, amlodipine, and hydrochlorothiazide).  

Symptoms of sprue-like enteropathy include severe, chronic diarrhea with substantial weight loss.

The FDA has approved label changes for olmesartan-containing drugs to include this warning. Sprue-like enteropathy has not been detected in other ARB drugs other than olmesartan. More information will be communicated following further evaluation of the safety of olmesartan-containing products.

Healthcare professionals are to tell patients to contact them if they develop severe, chronic diarrhea with substantial weight loss while taking an olmesartan-containing product, even if it takes months to years for symptoms to develop.

For more information visit FDA.gov.