A woman from Florida has added her Benicar side effects lawsuit to many others already filed in state and federal courts, alleging that drug caused her harmful intestinal symptoms.

Plaintiff Vanessa S. of Pensacola, Fla. was prescribed Benicar HCT, a variant of Benicar, in 2008. She subsequently developed gastrointestinal complications that are now known to be Benicar side effects. According to her Benicar lawsuit, these symptoms include,“gastrointestinal injury, chronic diarrhea, weight loss, nausea, vomiting, malnutrition, malabsorption, colitis or colitis-like symptoms, and dehydration.” These alleged Benicar side effects required additional medical treatment at Vanessa’s expense, in addition to causing her aggravated pain, suffering, and emotional distress.

Vanessa’s Benicar lawsuit implicates a large number of defendants. The Benicar side effects lawsuit was directed initially against the Daiichi Sankyo and Forest Laboratories families of companies; however, the lawsuit now also cites 350 unknown and unnamed defendants representing all persons or companies involved in the design, manufacture, marketing, distribution, or sale of Benicar.

This Benicar Lawsuit is Case No. 2:15-cv-02076-MCA-JBC, in the U.S. District Court for the District of New Jersey.

Side Effects of Benicar

Benicar was approved by the FDA in April 2002 for the treatment of hypertension. Benicar is sometimes referred to as olmesartan, after the name of its active ingredient olmesartan medoxomil. It is one of a class of medications called angiotensin II receptor blockers, and it is the seventh and most recent of such medications to enter the market.

Benicar HCT, the variant of Benicar that Vanessa took, has an additional ingredient of hydrochlorothiazide, another common blood pressure medication. Daiichi Sankyo markets Benicar as one of a group of olmesartan medications known as the Benicar Family – the others such medications being Benicar HCT, Azor and Tribenzor.

In July 2013, the FDA issued a Drug Safety Communication, alerting consumers and physicians to the fact that all drugs in the Benicar family can cause an intestinal condition known as sprue-like enteropathy. This condition causes symptoms similar to those of celiac disease, including severe and chronic diarrhea with resulting weight loss. More extreme cases of sprue-like enteropathy may require hospitalization. One Benicar side effects study found a connection between olmesartan use and villous atrophy.

Vanessa’s Benicar lawsuit alleges that the clinical trials used to evaluate the safety of Benicar were too short to address the drug’s intestinal side effects. Typical use of Benicar is long-term, lasting six months or more, and sprue-like enteropathy commonly manifests as a long-lasting chronic condition, but the clinical trials for olmesartan lasted no longer than three months.

Questionable Practices Surrounding Benicar Marketing

Benicar and other olmesartan products have been some of the most popular angiotensin II receptor blockers on the market. In 2012, olmesartan-based medications were dispensed to about 1.9 million U.S. patients. Between 2002 and 2008, Daiichi Sankyo spent $1 billion promoting Benicar and Benicar HCT.

However, in 2006, the FDA ordered Daiichi Sankyo to cease certain Benicar marketing practices based on findings that the company’s claims of efficacy and safety were unsubstantiated and misleading. There was apparently no evidence supporting the manufacturer’s claim that Benicar was safer or more effective than other drugs in its class. The FDA also found Daiichi Sankyo’s package labeling omitted important information about certain risks and improperly minimized information about other possible Benicar side effects. Vanessa’s Benicar lawsuit alleges that the current labeling does not disclose any risks of Benicar gastrointestinal side effects associated with long-term use of that drug.