Attorneys for a plaintiff who was diagnosed with sprue-like enteropathy after taking Benicar have asked a panel of federal judges to centralize dozens of other similar Benicar lawsuits in one federal Multidistrict Litigation (MDL), disputing recent claims made by the drug maker that reports of sprue-like enteropathy in Benicar users are rare.

The Dec. 18 motion was filed with the U.S. Judicial Panel on Multidistrict Litigation (JPML) on behalf of Plaintiff Annette J., requesting that the close to 30 Benicar lawsuits that have been filed in federal and state courts across the nation be transferred to the Northern District of Ohio. According to the request, 9 federal cases are already pending in Ohio, and more are expected to be filed there in the coming months. The complaints commonly allege that Benicar side effects caused users to suffer chronic diarrhea, indigestion, and sprue-like enteropathy.

Annette and the plaintiffs of the other Benicar lawsuits further accuse drug-maker Daiichi Sankyo Inc. of designing Benicar in a defective manner, as well as failing to warn consumers that it could cause persistent diarrhea and sprue-like enteropathy, a gastrointestinal condition similar to celiac disease. Forest Laboratories has been accused of marketing Benicar alongside Daiichi, despite the known negative side effects.

In July 2013, the U.S. Food & Drug Administration (FDA) warned that there was “clear evidence” of a link between Benicar and diarrhea, weight loss, and other related symptoms. Reports indicated a causal relationship, as the problems with Benicar stopped when users quit the drug and resumed once again when the high blood pressure treatment was continued. FDA warned that Benicar users may develop gastrointestinal problems months or even years after they begin treatment, often resulting in the need for hospitalization.

What is Benicar?

Benicar (olmesartan) is a prescription medication for high blood pressure. It was developed by Daiichi Sankyo, approved by the in 2002, and is still sold in the United States by Forest Laboratories. Nearly 2 million people received a prescription for Benicar in 2012.

What is Sprue-Like Enteropathy?

Sprue-like enteropathy is a type of gastrointestinal inflammation that causes chronic diarrhea and weight-loss. Sprue-like enteropathy symptoms are very similar to celiac disease (gluten hypersensitivity), which has caused some Benicar users to be misdiagnosed. Over time, sprue-like enteropathy causes problems with the digestion and absorption of food. It damages the mucous lining of the intestines, destroys intestinal villi, and flattens the lining of the intestines.

What Causes Sprue-Like Enteropathy?

Benicar belongs to a class of drugs known as angiotensin II receptor blockers (ARB), which also includes Azor and Tribenzor. Other drugs in the ARB class have not been associated with sprue-like enteropathy. No one knows the exact cause, but is could possibly occur due to a localized hypersensitivity reaction, a cell-mediated immune response, or inhibition of TGF-β (an important mediator of gut homeostasis).

Benicar and Sprue-Like Enteropathy

In 2012, a report on the suspected link between sprue-like enteropathy and Benicar was published by the Mayo Clinic, which described cases similar to celiac disease among Benicar users. Physicians acknowledged that the gastrointestinal conditions resolved when the blood pressure drug was no longer used. The Mayo Clinic study reported 22 patients suffering from gastrointestinal injuries allegedly brought on by Benicar use. One of the study’s top authors reportedly believes these cases are the “tip of the iceberg,” in terms of Benicar side effects.

In July 2013, the U.S. Food & Drug Administration (FDA) warned that there was “clear evidence” of a link between Benicar and diarrhea, weight loss and other related symptoms. Reports indicated a causal relationship, as the problems with Benicar stopped when users quit the drug and resumed once again when it was continued. FDA warned that Benicar users may develop gastrointestinal problems months or even years after they begin treatment, often resulting in the need for hospitalization.

In March 2014, the journal Digestive and Liver Disease published a study linking Benicar and five cases of sprue-like enteropathy (chronic diarrhea and weight-loss), bringing the total number of known Benicar side effects cases to 27. According to researchers: “All cases were observed in a small gastroenterology unit, which suggests that this adverse effect may not be rare.” As a result, some users have filed Benicar lawsuits to receive awards for the damages sustained.