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FDA warns of potential intestinal issues associated with olmesartan medoxomil, OKs labeling change
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The FDA has approved labeling changes to drugs containing olmesartan medoxomil, warning of the potential for intestinal problems, according to a press release.
The blood pressure medication, marketed as Benicar, Benicar HCT, Azor and Tribenzor, as well as in generic form, is one of eight available angiotensin II receptor blockers (ARBs) and is intended for use in patients with hypertension, alone or in combination with other agents. The new labeling warns of the potential for recipients to develop sprue-like enteropathy, which can occur months or years after initiating treatment with the drug and may require hospitalization in severe cases. Current labeling includes diarrhea as a potential adverse event related to the medication.
Symptoms of sprue-like enteropathy include severe, chronic diarrhea and significant weight loss. Patients treated with olmesartan medoxomil should immediately be switched to another antihypertensive drug if these symptoms develop with no other discernible cause. The condition has not been associated with other ARB medications, and the mechanism behind its development in olmesartan users is unclear, according to the release.
The labeling change follows the identification of 23 serious incidents of late-onset diarrhea and weight loss in the FDA’s Adverse Event Reporting System, some of which also presented with intestinal villous atrophy. All patients experienced clinical improvement after stopping treatment. Similarly, a case series published in June 2012 by Mayo Clinic included 22 olmesartan medoxomil recipients with sprue-like symptoms, with clinical and histological improvement observed following discontinuation of treatment.