A woman from Mississippi has added her claim to the multidistrict litigation, or MDL, over side effects of Benicar.

Plaintiff Doris W. says she started taking Benicar and Benicar HCT in 2009. She later developed severe gastrointestinal problems including villous atrophy, sprue-like enteropathy, and colitis.

These conditions came with symptoms like “chronic diarrhea, rapid and severe weight loss, nausea, vomiting, malabsorption, malnutrition, dehydration, atrophy, abdominal pain, possible renal failure, possible kidney failure and or other related symptoms.” These symptoms were so severe Doris had to be hospitalized.

Based on these allegations of Benicar issues, and her reactions, Doris is suing Daiichi Sankyo Inc., Forest Laboratories LLC, and their related companies, all of whom are allegedly involved in the manufacture and distribution of Benicar.

She is asserting all claims on the MDL’s short form complaint that are available for a living victim of Benicar side effects. These claims are based on theories of design defect, failure to warn, negligence, misrepresentation and fraud, breach of warranty, unjust enrichment, and violation of state consumer protection laws – which in Doris’s case are the laws of Mississippi.

Benicar and Sprue-Like Enteropathy

Benicar is an angiotensin II receptor blocker used to treat hypertension. It’s been on the market since receiving initial FDA approval in 2002.

Some brand-name drugs combine Benicar’s active ingredient olmesartan with other cardiovascular drugs: Benicar HCT combines olmesartan with hydrochlorothiazide, Azor combines it with amlodipine, and Tribenzor combines all three. All four of these brand-name drugs are at issue in the Benicar MDL.

Unfortunately, Benicar can also cause a certain severe gastrointestinal condition called sprue-like enteropathy. This condition presents with symptoms similar to celiac disease, with the main difference being that sprue-like enteropathy originates as the side effect of a drug, not from a hypersensitivity to gluten.

Consequently, sprue-like enteropathy is sometimes referred to as drug-induced enteropathy, or as in the Benicar MDL, olmesartan-induced enteropathy.

The characteristic symptoms of sprue-like enteropathy are severe and chronic diarrhea, substantial weight loss, and villous atrophy, a condition in which the structures on the inner surface of the small intestine erode away, causing malabsorption.

The FDA issued a warning about the risk of sprue-like enteropathy in a July 2013 Drug Safety Communication. The communication says that sprue-like enteropathy may not develop until months or even years after starting to take olmesartan, and as in Doris’s case it may be severe enough to require hospitalization.

The FDA notes that sprue-like enteropathy has not been detected in conjunction with other angiotensin II receptor blockers – so the problem seems to come up only with Benicar and other drugs in the Benicar family.

The communication also refers to recent research studies that have detailed cases of sprue-like enteropathy related to olmesartan. A Mayo Clinic study published in June 2012 described 22 cases in which discontinuing olmesartan resulted in improvement of gastrointestinal symptoms.

Another study from May 2013 noted that some patients initially classified as having “unclassified sprue” were later found to have villous atrophy caused by olmesartan.

The Benicar MDL is underway in the U.S. District Court for the District of New Jersey, MDL No. 2606.