Olmesartan-associated Sprue-like Enteropathy FDA Warning Also Applies To Benicar HCT, Azor, And Tribenzor From Drug Company Daiichi Sankyo
The FDA has found clear evidence of an association between the blood pressure drug Benicar (olmesartan) and a serious intestinal condition known as sprue-like enteropathy, which is characterized by severe diarrhea or diarrhea that does not go away and, often, significant weight loss.
It is important to note that some patients developed this serious intestinal side effect enteropathy, which can require hospitalization, months to years after first starting to take Benicar.
From a July 3, 2013 MedPage Today news report, "FDA Adds GI Warning to Benicar Label":
The connection between sprue-like enteropathy and [Benicar (olmesartan)] was first reported in June 2012 by Mayo Clinic researchers who, from 2008-2010, had seen 22 patients with symptoms suggestive of celiac disease but antibody blood tests that did not support the diagnosis.
Later in October 2012, researchers at the American College of Gastroenterology meeting noted that [Benicar (olmesartan)], an angiotensin II receptor blocker, or ARB, had been linked to another 40 such cases of sprue-like enteropathy.
"We believe it is the tip of the iceberg," said Margot Herman, MD, at the GI meeting.
Symptoms of sprue-like enteropathy include severe, chronic diarrhea with substantial weight loss.
The 22 initial patients reported by the Mayo Clinic were on average 69 years old and had a duration of diarrheal illness for an average of 19 months.
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In early July 2013 this FDA Drug Safety Communication was issued, "FDA approves label changes to include intestinal problems (sprue-like enteropathy) linked to blood pressure medicine olmesartan medoxomil [(e.g., Benicar, Benicar HCT, Azor, and Tribenzor)]". It began by informing that the FDA has approved changes to the labels of these drugs in include the fact that these drugs can cause serious intestinal problems.
The Warnings and Precautions part of the July 2013 revised Benicar Prescribing Information, or drug label, sets forth this new warning about these serious intestinal side effects:
5.5 Sprue-like Enteropathy
Severe, chronic diarrhea with substantial weight loss has been reported in patients taking olmesartan months to years after drug initiation. Intestinal biopsies of patients often demonstrated villous atrophy. If a patient develops these symptoms during treatment with olmesartan, exclude other etiologies. Consider discontinuation of Benicar in cases where no other etiology is identified.
Previously the Daiichi Sankyo drug labels for Benicar, Benicar HCT, Azor, and Tribenzor included a mention of diarrhea in the Adverse Reactions section.
According to the July FDA Drug Safety Communication about Benicar and similar blood pressure medications containing the same active ingredient:
In 2012, a total of approximately 10.6 million prescriptions were dispensed, and approximately 1.9 million patients received a dispensed prescription for olmesartan-containing products from U.S. outpatient retail pharmacies.
Further, it states that the FDA will continue to evaluate the safety of olmesartan-containing products such as Benicar, Benicar HCT, Azor, and Tribenzor.
As regards legal cases, we are investigating some Benicar-related enteropathy reports from patients as drug injury claims against the pharmaceutical company Daiichi Sankyo.