A West Virginia man says his chronic gastrointestinal symptoms from Benicar surpassed what he was led to expect from the product’s labeling.
Plaintiff David H. alleges defendants Daiichi Sankyo, Forest Laboratories and their related business entities failed to adequately warn him about the risk of chronic gastrointestinal symptoms from Benicar.
David says he began taking Benicar in December 2013. Later, he developed severe gastrointestinal side effects. He reports suffering from uncontrollable diarrhea, cramping and nausea, as well as headaches.
According to David’s Benicar lawsuit, his chronic gastrointestinal symptoms from Benicar affect more than just his physical health.
These symptoms have limited his ability to participate in family, social and work activities, he claims. He says he is less able to travel, maintain employment, and spend time with his wife because he must plan everything he does around his constant need for access to a bathroom.
Benicar, also known as olmesartan, was approved by the FDA in 2002 as a treatment for hypertension. Daiichi Sankyo developed and manufactures Benicar and its related olmesartan-based drugs and co-promotes them through an agreement with Forest Laboratories.
Since then, three other medications have come along that combine olmesartan with other cardiovascular drugs. Benicar HCT combines olmesartan with hydrochorothiazide, Azor combines it with amlodipine, and Tribenzor combines all three of those ingredients into a single medication.
Benicar Side Effects Litigation
All four of these olmesartan-based medications are implicated in a multidistrict litigation, or MDL, addressing chronic gastrointestinal symptoms from Benicar.
This MDL is a consolidation of many individual Benicar lawsuits from patients like David who allege they suffered extreme gastrointestinal side effects after taking olmesartan-based drugs. U.S. District Judge Robert B. Kugler of the District of New Jersey has been overseeing pretrial proceedings in this MDL since April 2015.
Benicar gastrointestinal side effects are often diagnosed as sprue-like enteropathy, a condition with symptoms similar to those of celiac disease. Patients with sprue-like enteropathy typically suffer from chronic and severe diarrhea that is extreme enough to cause malnutrition, dehydration and significant weight loss.
Plaintiffs in the Benicar MDL allege Daiichi Sankyo and Forest Laboratories knew about the risk of sprue-like enteropathy linked to olmesartan, yet kept that information under wraps to avoid harming sales of their hypertension drugs.
Clinical studies and aftermarket reports submitted to the FDA show that patients taking olmesartan-based drugs have developed cases of sprue-like enteropathy. Case studies have been available that report rapid weight loss of dozens of pounds in an unusually short amount of time.
Some of these cases were initially diagnosed as celiac disease until blood test results confirmed the correct diagnosis. In many reported cases, the patients’ symptoms improved after they stopped taking olmesartan-based drugs.
Yet the defendants continue to market Benicar as a safe and effective treatment for hypertension. Had the plaintiffs been properly informed about the risk of sprue-like enteropathy associated with Benicar, they say they would not have taken it in the first place.
David’s Benicar Lawsuit is Case No. 1:17-cv-01532. The Benicar MDL is In re: Benicar (Olmesartan) Products Liability Litigation, MDL No. 2606 in the U.S. District Court for the District of New Jersey.
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