A California resident is suing Daiichi Sankyo and Forest Laboratories, seeking compensation for Benicar side effects.

Plaintiff Willie F. of California says he took Benicar as prescribed by his doctor. Wilie says that while taking Benicar, he developed severe intestinal symptoms including “sprue-like enteropathy, lymphocytic colitis, microscopic colitis, collagenous colitis, and/or intestinal malabsorption.” These conditions caused him to suffer a variety of ailments, including: chronic diarrhea, rapid weight loss, nausea, vomiting, malnutrition, and dehydration.

Willie says he continues to need regular medical monitoring and treatment for these symptoms. He alleges severe emotional distress related to his Benicar side effects, and he says treating them has incurred significant medical expenses.

Willie is suing Daiichi Sankyo Inc., Forest Laboratories Inc., and their related companies. Daiichi Sankyo and Forest Laboratories manufacture and distribute the medications Benicar, Benicar HCT, Azor and Tribenzor, all of which are used to treat hypertension. These drugs use the active ingredient olmesartan medoxomil, sometimes in combination with other drugs. Daiichi Sankyo and Forest Laboratories refer to these drugs as the “Benicar family.”

Olmesartan and the Benicar Family

Since the FDA first approved olmesartan in April 2002 as a treatment for hypertension, sales of the Benicar family and generic equivalents have been substantial. In 2012 alone, physicians dispensed over 10 million prescriptions for olmesartan products.

In July 2013, the FDA issued a drug safety communication warning that Benicar and other olmesartan products can cause a set of intestinal symptoms known as sprue-like enteropathy. This condition can cause severe and chronic diarrhea and weight loss, and treating it may require hospitalization.

The communication says that sprue-like enteropathy may begin months or years after starting olmesartan treatment. The FDA notes that discontinuation of olmesartan has resulted in improvement of enteropathy symptoms in all patients. The communication recommends discontinuing olmesartan if no other cause for the enteropathy can be found.

The agency also announced a change in the labeling for the Benicar family of drugs, adding a warning about the risk of sprue-like enteropathy.

The FDA issued the Benicar communication following receipt of 23 reports of serious cases of late-onset diarrhea with significant weight loss. In all these cases, the patients’ symptoms improved following discontinuation of olmesartan. A study from the Mayo Clinic published in June 2012 showed similar results. These reports showed clear evidence of an association between olmesartan and sprue-like enteropathy.

Willie now argues that the clinical trials for the Benicar family were too short to evaluate the risk of sprue-like enteropathy associated with those drugs. The trials, which Willie claims lasted no longer than three months, were not comparable to the length of some Benicar treatment regimens, which he says can last six months to a full year or more. Since sprue-like enteropathy may manifest several months or years after starting olmesartan, the three-month trials would be inadequate to detect a relationship between Benicar and that condition, he says.

Willie’s Benicar Lawsuit is part of the Benicar Multidistrict Litigation, MDL no. 2606, in the U.S. District Court for the District of New Jersey.