On July 3, 2013, the FDA issued a warning that the blood pressure drug Benicar (olmesartan medoxomil) can cause intestinal problems known as sprue-like enteropathy. Symptoms of sprue-like enteropathy include severe, chronic diarrhea with substantial weight loss. The enteropathy may develop months to years after starting Benicar, and sometimes requires hospitalization. The FDA further required the drug’s manufacturer, Daiichi Sankyo, to change Benicar’s warning label to include the risk of these side-effects.
Benicar is an angiotensin II receptor blocker (ARB) approved for the treatment of high blood pressure, alone or with other antihypertensive agents, and is one of eight marketed ARB drugs. The current Benicar drug labels include diarrhea in the Adverse Reactions section, but does not mention sprue-like enteropathy, villous atrophy, nor celiac disease.
The FDA evaluated injury reports received from doctors, various medical studies and published literature regarding the safety and efficacy of Benicar. The FDA’s evaluation found clear evidence of an association between Benicar and sprue-like enteropathy. In fact, the FDA has identified 23 serious cases presenting as late-onset diarrhea with significant weight loss and, in some cases, with intestinal villous atrophy on biopsy.
In May 2013, a medical article describing patients with serious intestinal pain and discomfort (called villous atrophy), who had no family history or predisposition to the problem, reported that some of the patients were found to have villous atrophy associated with Benicar use.
Then, in June 2012, Mayo Clinic researchers published a case series of sprue-like enteropathy associated with Benicar in 22 patients whose clinical presentation was similar to that of the 23 cases previously identified by the FDA. Patients in the Mayo Clinic case series also developed diarrhea, weight loss, and villous atrophy while on Benicar, and drug discontinuation resulted in clinical improvement. Eighteen patients had follow-up intestinal biopsies demonstrating recovery or improvement of the intestinal problems after discontinuation of Benicar.
The FDA then further researched the connnection between sprue-like enteropathy and Benicar use. The patient data the FDA reviewed showed that after taking Benicar for at least 2 years, Benicar users had a higher rate of celiac disease diagnoses than users of other ARBs. The FDA further warned that Sprue-like enteropathy has not been detected with ARB drugs other than Benicar. The FDA’s research suggests that the problem may have something to do with Benicar’s chemical formula, but has not pinpointed why this effect is not observed with ARB drugs other than Benicar.
In 2012, a total of approximately 10.6 million prescriptions were dispensed, and approximately 1.9 million patients received a dispensed prescription for Benicar products from U.S. outpatient retail pharmacies.
If you or a loved one has taken Benicar and developed severe intestinal problems, contact our team of lawyers to help assert your legal rights.