Another plaintiff has been added to the Benicar multidistrict litigation in New Jersey over claims that the blood pressure medication caused severe injuries including chronic diarrhea.
Plaintiff Virgil P. of Kentucky is suing the makers of Benicar, Daiichyo Sankyo Inc., Forest Laboratories LLC, and their related companies. Virgil says he began taking Benicar in October 2010.
Later, Virgil says, he developed what he calls “[s]erious gastrointestinal and/or colonic injuries, including but not limited to villous atrophy, sprue-like enteropathy, colitis, kidney failure, malabsorption, malnutrition, dehydration, atrophy and/or symptoms of diarrhea, vomiting, nausea, abdominal pain” and other symptoms.
Virgil attributes these side effects and their associated medical expenses to his regimen of Benicar.
Benicar Side Effects
Benicar is a drug used to treat hypertension. It was first approved for that use by the FDA in 2002. The same active ingredient, olmesartan, is also used in combination with other cardiovascular drugs in products sold under the brand names Benicar HCT, Azor, and Tribenzor.
According to the master complaint for the Benicar multidistrict litigation, defendant Daiichi Sankyo refers to these drugs together as the “Benicar Family.”
The main issue raised by Virgil and other plaintiffs in Benicar lawsuits is the possibility that treatment with products in the Benicar Family may lead to an intestinal condition known as sprue-like enteropathy.
Sprue-like enteropathy is a condition with symptoms similar to those of celiac disease – the main difference being that celiac disease symptoms result from exposure to gluten, whereas sprue-like enteropathy is often caused by drugs like Benicar. Both conditions involve villous atrophy, a degradation of the intestinal mucosa that results in malabsorption of nutrients.
Characteristic symptoms of sprue-like enteropathy include chronic diarrhea, weight loss, nausea, vomiting, anemia, fatigue, bloating, and abdominal pain.
FDA Benicar Warning
The plaintiffs cite a Drug Safety Communication by the FDA that addressed sprue-like enteropathy in July 2013. The FDA’s warning notifies patients and physicians that treatment with Benicar and other drugs containing olmesartan can lead to sprue-like enteropathy.
The federal agency says this condition can develop months or even years after starting olmesartan, and it may be severe enough to require hospitalization.
The FDA cited 23 cases reported to its Adverse Event Reporting System in which patients with diarrhea and significant weight loss reported improvement of symptoms after discontinuing olmesartan.
The federal agency also cited a study published in Mayo Clinic Proceedings in June 2012 that described 22 similar cases in which patients experiencing diarrhea, weight loss and villous atrophy reported their symptoms improved after olmesartan was discontinued.
A third article published in the American Journal of Gastroenterology in May 2013 described the cases of some patients whose symptoms had first been identified as “uncharacterized sprue” but were later found to be symptoms of villous atrophy associated with olmesartan.
Benicar Multidistrict Litigation
Virgil’s individual Benicar lawsuit is part of the multidistrict litigation over Benicar side effects now pending in federal court in New Jersey. This MDL is a collection of similar Benicar lawsuits all transferred to the same court so that pretrial procedures can be conducted more efficiently and more consistently.
The Benicar Lawsuit is Case No. 1:15-cv-07269-RBK-JS and MDL No. 2606 in the U.S. District Court for the District of New Jersey.
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