Benicar, a high blood pressure drug, has been linked to more than 60 probable cases of severe sprue-like enteropathy with gastrointestinal symptoms that include severe, chronic diarrhea and substantial weight loss.

Benicar has been prescribed to help lower high blood pressure in patients by helping the blood vessels in the body to widen and preventing constriction of the vessels. It is sometimes given together with other blood pressure medications. Benicar is one of eight marketed angiotensin receptor blockers (ARB) drugs, and the only one linked to sprue-like enteropathy.

An estimated 1.9 million people received prescriptions for Benicar or a related drug in 2012, and about 10.6 million prescriptions for Benicar products were dispensed altogether that year. It is the third highest selling ARB blood pressure medication on the market.

Benicar Side Effects

The symptoms of Benicar enteropathy are very similar to those of celiac disease. Unlike celiac disease, a gluten-free lifestyle will not improve the symptoms. The only way to improve Benicar enteropathy is by discontinuing the medication. Some of the side effects of Benicar include:

• Chronic diarrhea
• Vomiting
• Rapid and excessive weight loss
• Dehydration
• Cardiovascular problems

Recent studies have suggested that there is a link between side effects of Benicar and chronic diarrhea, which may have gone undiagnosed in patients for years. In many cases, these stomach problems were misdiagnosed as celiac disease, which may actually be related to Benicar enteropathy.

The U.S. Food and Drug Administration (FDA) indicated at least 23 cases of diarrhea from Benicar were identified among adverse event reports submitted by users of the drug whose symptoms improved after the medication was discontinued. In 10 of the cases, symptoms returned against when the medication was resumed. This led the FDA to indicate that there is “clear evidence” of an association between Benicar and enteropathy.

On July 4, 2013, the FDA issued a warning that Benicar causes sprue-like enteropathy. According to the FDA warning, symptoms of sprue-like enteropathy include severe, chronic diarrhea with substantial weight loss. The FDA approved changes to the labels of Benicar to include this concern.

Prior to the FDA warning, the Mayo Clinic in Rochester, Minn., studied 22 patients hospitalized and presenting symptoms similar to celiac disease – unexplained chronic diarrhea, weight loss and enteropathy. But, unlike celiac disease, these patients were unable to control these symptoms with a gluten-free lifestyle and antibody blood tests did not support a diagnosis of celiac disease.

The Mayo Clinic discovered that each of the patients was prescribed Benicar for hypertension. Suspecting this was more than a coincidence, the Mayo clinic asked the patients to discontinue their usage of Benicar. After discontinuing Benicar, the patients confirmed that the chronic diarrhea, vomiting, weight loss and other intestinal inflammation symptoms improved.

Following the studies conducted by the Mayo Clinic that linked Benicar to sprue-like enteropathy, patients have filed Benicar lawsuits after experiencing celiac disease-mimicking gastrointestinal symptoms.

Many of these lawsuits claim that the manufacturer of Benicar, Daiichi Sankyo, knew of the link between Benicar and the rare gastrointestinal disease caused by its drug, but did not properly warn the public of the risk. Daiichi Sankyo allegedly put profits ahead of public safety.