Benicar (olmesartan medoxomil), a drug used to treat hypertension, has recently been associated with multiple medical complications that have sparked a series of lawsuits. The Benicar lawsuits allege the medication is defective, and the manufacturer failed to adequately warn consumers of the risks.

An Illinois woman, Toni V., is one of the most recent plaintiffs to file a Benicar lawsuit against the drug’s manufacturer, Daiichi Sankyo, alleging she suffered injuries as a result of ingesting Benicar.

While taking Benicar at the recommended dosage, Toni alleges she developed sprue-like enteropathy, an intestinal disease, as well as other personal injuries including lymphocytic colitis, microscopic colitis, or collagenous colitis, that have necessitated screening, testing, and treatment, as well as constant monitoring.

Toni alleges that ingesting Benicar caused her to suffer serious and life threatening physical injuries as well as severe emotional distress. She claims that she has been forced to spend significant money on the medical care required for her treatment, and will continue to do so in the future.

Toni’s Benicar lawsuit brings claims of defective design, failure to warn, gross negligence, negligent misrepresentation, fraudulent concealment, and violation of Illinois’ consumer protection laws.

Connection Between Benicar and Sprue-like Enteropathy

In her Benicar lawsuit, Toni alleges that Daiichi Sankyo either knew or should have known that medical and scientific literature has associated olmesartan medoxomil and sprue-like enteropathy, as well as other medical conditions. Numerous case studies have been published in recent years, including a study published by Mayo Clinic researchers in 2012.

Part of the issue, Toni alleges, is that Daiichi Sankyo only held clinical trials for three months, while Benicar and Benicar products are often prescribed for periods of six months to a year. Toni claims that Daiichi Sankyo failed to perform reasonable and necessary prolonged clinical trials to determine the effects of longer term cumulative exposure to olmesartan.

Toni also claims that Daiichi Sankyo has, over the years, marketed their Benicar products in false or misleading ways which omit and/or minimize the potential risks associated with the drug. The company continued to make claims as to the efficacy of their products, but did not conduct any clinical outcome trials that would prove this efficacy. In contrast, makers of similar drugs have performed such clinical outcome trials to investigate long-term risks.

Benicar and the FDA

Benicar tablets were first approved by the United States Food and Drug Administration (FDA) to treat hypertension in 2002.

In July of 2013, the FDA followed up this approval with a Drug Safety Communication warning that the drug Benicar, also marketed as Benicar HCT, Azor, and Tribenzor, can cause medical complications such as sprue-like enteropathy. Sprue-like enteropathy is a serious intestinal problem, which causes such complications as chronic diarrhea, weight gain, and other serious gastrointestinal problems.

Also in 2013, the FDA approved changes to the medications’ labels, adding a warning about sprue-like enteropathy. The FDA included several of their findings in their official recommendation for label changes.

The FDA found that sprue-like enteropathy may develop from months to years after starting olmesartan medoxomil, and sometimes requires hospitalization. If symptoms of sprue-like enteropathy develop, such as severe, chronic diarrhea with substantial weight loss, and no other cause is found, the FDA recommends that the drug should be discontinued immediately.

If you have experienced adverse effects such as chronic diarrhea after taking Benicar, you may be able to file a Benicar lawsuit.

The Benicar Chronic Diarrhea Lawsuit is Case No. 1:15-cv-04099-RBK-JS, in the U.S. District Court for the District of New Jersey.