A woman from Washington who suffered from severe intestinal symptoms is suing the makers of Benicar, claiming her symptoms were side effects of the hypertension drug.

Plaintiff Judi H. says she was prescribed Benicar in 2008 and took it continuously through 2010. While taking Benicar, Judi developed a set of intestinal problems known as sprue-like enteropathy. She found herself suffering from “gastrointestinal injury, chronic diarrhea, weight loss, nausea, vomiting, malnutrition, malabsorption, colitis or colitis-like symptoms, and dehydration.” She now alleges these symptoms were Benicar side effects.

Her Benicar lawsuit names as defendants Daiichi Sankyo Inc., Forest Laboratories Inc., and their related companies, who manufacture Benicar HCT.

Benicar and Sprue-Like Enteropathy

Benicar is a brand name for olmesartan medoxomil. Olmesartan is an angiotensin II receptor blocker, or ARB, used to treat hypertension. According to Judi’s Benicar lawsuit, olmesartan is also used in the brand-name drugs Azor and Tribenzor. The formulation Judi took, Benicar HCT, is a combination of olmesartan and hydrochlorothiazide, another drug used to treat cardiovascular conditions.

As Judi notes in her Benicar lawsuit, the FDA issued a Drug Safety Communication in July 2013 announcing that olmesartan medoxomil can cause sprue-like enteropathy. This condition is distinguished by intestinal symptoms such as severe and chronic diarrhea with attendant weight loss. The FDA’s communication also announced a label change adding a warning about sprue-like enteropathy as a Benicar side effect.

The FDA based its safety communication in part from reports of Benicar side effects submitted to FDA’s Adverse Event Reporting System. Twenty-three serious cases of sprue-like enteropathy were reported there. In some cases, the patients also had evidence of intestinal villous atrophy.

A study published by researchers from the Mayo Clinic in June 2012 reported findings similar to those in the FDA adverse event reports. Twenty-two patients who developed sprue-like enteropathy associated with olmesartan treatment came down with chronic diarrhea, weight loss, and villous atrophy. The researchers found these symptoms resolved after the patients discontinued olmesartan.

The FDA communication also noted a May 2013 study of patients with villous atrophy who had been characterized as having “unclassified sprue.” In some of these patients, their villous atrophy was later linked to their use of olmesartan.

Researchers did not find a relationship between sprue-like enteropathy and any other ARB medications besides olmesartan.

Judi alleges that the defendants knew or should have known these study results showing a link between Benicar and sprue-like enteropathy. She alleges that the clinical trials for olmesartan products like Benicar were not long enough to evaluate the relationship between olmesartan and sprue-like enteropathy, which typically takes several months to develop.

Benicar Lawsuits

Judi’s Benicar lawsuit raises claims for defective design, failure to warn, strict products liability, negligence, negligent and fraudulent misrepresentation, fraud and fraudulent concealment, and breach of warranty.

She seeks an award of punitive damages based on the defendant’s allegedly intentional and knowing acts, which Judi alleges indicate a “reckless disregard for the public safety and welfare.”

The Benicar Lawsuit is Case No. 0:15-CV-2407, in the U.S. District Court for the District of Minnesota.