July 4th, 2013

FDA: Olmesartan Can Cause Sprue-Like Enteropathy

The FDA is warning that the angiotensin II receptor blocker olmesartan (marketed as Benicar, Benicar HCT, Azor, Tribenzor, and generics) may cause severe diarrhea. According to an FDA safety announcement, olmesartan “can cause intestinal problems known as sprue-like enteropathy. Symptoms of sprue-like enteropathy include severe, chronic diarrhea with substantial weight loss.” The warning is being added to the label of drug products containing olmesartan.

The FDA said that it has found no evidence that other angiotensin II receptor blockers increase the risk for sprue-like enteropathy.

The FDA recommends that physicians tell their patients taking olmesartan to contact them if the patients develop severe, chronic diarrhea with substantial weight loss. Symptoms may take months or years to develop after initiation of olmesartan therapy. The FDA advises physicians to look for other causes of the symptoms, including celiac disease. Olmesartan should be replaced with another antihypertensive agent if no other cause of symptoms is found.



2 Responses to “FDA: Olmesartan Can Cause Sprue-Like Enteropathy”

  1. Maarten Vasbinder, MD says:

    Every day we get warnings about secondary effects of medicines and mostly form the exotic “me too” medicines, which have not be tested as thoroughly as the first ones of its groups. Moreover the industry has the ugly habit to only publish positive data. Being a doctor can make you dangerous to patients, because we cannot know what has not been published.

  2. Kasim Salim, MBBS MD MRCP FRCP MRCpath FRCpath says:

    Could anyone explain why such an autoimmune enteropathy results from Olmesartan and not the others in the same category as Losartan, Telmesartan and Candesartan. Is this in anyway connected to the molecular structure of Olmesartan? I have a personal concern as I am on a high dose of Candesartan with a view to control my Blood pressure and LV diastolic dysfunction. It has come the point that I won’t recommend Olmesartan for any of my patients.