On July 3, 2013, the Food and Drug Administration (FDA) published a drug safety warning about side effects of the medications Benicar® and Benicar HCT® (olmesartan medoxomil). Benicar is an antihypertensive agent used to treat heart failure and hypertension, or high blood pressure. Benicar’s adverse side effects include gastrointestinal problems known as spruelike enteropathy.
Symptoms of spruelike enteropathy present similarly to those experienced by individuals with Celiac disease (gluten intolerance). Patients with spruelike enteropathy can suffer from side effects including:
The FDA approved Benicar® (olmesartan medoxomil) in 2002. Olmesartan belongs to the class of drugs called angiotensin II receptor blockers (ARBs). ARBs lower blood pressure by preventing a patient’s blood vessels from narrowing, improving blood flow and lowering blood pressure. To date, no other ARB medications are linked to spruelike enteropathy.
From 2008 to 2011, Mayo Clinic researchers investigated patients taking olmesartan with severe spruelike enteropathy-unexplained chronic diarrhea and intestinal disease. The study noted a diagnosis of Celiac disease was ruled out in all patients. The conclusion from the original article states, “Olmesartan may be associated with a severe form of spruelike enteropathy. Clinical response and histologic recovery are expected after suspension of the drug.” Patients’ symptoms are expected to improve and resolve after discontinuing the drug.
The American College of Gastroenterology notes Benicar®-associated enteropathy (disease of the intestines) is a nonceliac enteropathy causing villous atrophy or erosion of the lining in the small intestines. The villous atrophy leads to nutrient malabsorption, wasting, and diarrhea.
The FDA’s Adverse Event Reporting System (FAERS) documented 23 serious cases of similar symptoms in Benicar® patients. The agency evaluated these reports of Benicar’s gastrointestinal side effects and “found clear evidence of an association between olmesartan and spruelike enteropathy….presenting as late-onset diarrhea with significant weight loss and, in some cases, with intestinal villous atrophy on biopsy. All patients improved clinically after discontinuation of olmesartan, and a positive rechallenge was seen in 10 of the cases.” The FDA approved changes to the warning labels on Benicar® and Benicar HCT® to reflect an increasing risk of spruelike enteropathy; sections modified on the prescription drug labels or drug product labels by the FDA were the warnings, precautions and adverse reactions.
The FDA urges physicians of Benicar® patients exhibiting symptoms of this condition to discontinue treatment with Benicar® and prescribe a different antihypertensive drug.
Benicar® Events Timeline
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