Dr. Joseph Murray, a gastroenterologist with the Mayo Clinic, was the first to publish on the link between Benicar use and the rare sprue-like enteropathy condition. Dr. Murray’s three-year study observed 22 patients that used Benicar who were experiencing gastrointestinal symptoms commonly associated with Celiac disease.  Of the 22 patients, 14 had symptoms so severe that hospitalization was required.

Additionally, Dr. Murray’s patients did not respond to a gluten-free diet and they tested negative for Celiac disease.  After discontinuing the use of Benicar, all 22 patients in Dr. Murray’s study felt the relief of the gastrointestinal symptoms they were previously experiencing, as well as recovery of the weight loss they suffered while on Benicar.  Dr. Murray’s study is clear evidence that the only way to alleviate the symptoms of Benicar enteropathy is by discontinuing the medication.  Based on the study’s observations, Dr. Murray concluded that there was a link between the use of Benicar and sprue-like enteropathy, and his report has since been published in the Mayo Clinic Proceedings.

A French nationwide cohort study released in June 2014 revealed an association between Benicar and severe intestinal malabsorption, which can lead to malnutrition, substantial weight loss, dehydration, and severe chronic diarrhea. The study found no link in patients taking other antihypertensive drugs, including ACE inhibitors or angiotensin receptor blockers (ARBs).  The study also shows that patients who took Benicar for two or more years have 10 times the risk of suffering from these symptoms.

In July 2013, the U.S. Food and Drug Administration (FDA) approved a label change for Benicar to add a warning about the increased risks of sprue-like enteropathy to the drug’s label.  They also issued a safety warning that Benicar, Azor, and Tribenzor can cause intestinal problems (sprue-like enteropathy). Symptoms of the disorder include severe, chronic diarrhea with substantial weight loss.  In deciding to require new warnings, the FDA has evaluated numerous adverse event reports and found a direct link between Benicar, other olmesartan drugs like Azor and Tribenzor, and sprue-like enteropathy. Twenty-three serious cases were identified in these reports “as late-onset diarrhea with significant weight loss, and in some cases, with intestinal villous atrophy on biopsy.”