Daiichi Sankyo Inc.  faces allegations of failing to warn about the adverse side effects of the blood pressure medication, Benicar.

The plaintiffs, including Beverly D., seek monetary restitution, punitive damages, and other available remedies due to the defendant’s allegedly defective product. They claim their Benicar complications resulted in severe gastrointestinal side effects that led to malnutrition and rapid weight loss.

Benicar is a olmesartan medoxomil medication. It is available to be taken orally as film-coated tablets containing 5 mg, 20 mg, or 40 mg of olmesartan medoxomil. Other medications containing the allegedly “defective and unreasonably dangerous prescription olmesartan medoxomil drug products” include Tribenzor, Azor, and Benicar HCT.

Daiichi Sankyo, the defendant in this Benicar lawsuit, is headquartered in New Jersey and is the second largest global pharmaceutical company.

According to the Benicar complications lawsuit, the defendants had marketed Benicar and its related products to be safe and effective for treatment of hypertension, renal disease, and other medical conditions.

However, the Benicar complications lawsuit states that the “defendants … knew or should have known that use of olmesartan medoxomil products increased the risk of developing multiple injuries, including, but not limited to serious gastrointestinal injuries.”

Benicar complications reportedly include serious adverse effects such as abdominal and gastrointestinal pain, kidney failure, nausea, inflammation, weight loss, gastritis, and even death.

The Benicar complications lawsuit alleges that Daiichi Sankyo “failed to include such risks and misrepresented the safety of the drugs, and continue to inadequately and inaccurately disclose those risks today.”

The Benicar complications lawsuit further notes that had the plaintiffs’ medical practitioners been “properly warned by defendants regarding the risks from ingesting defendant’s olmesartan products, the plaintiffs would not have ingested these drugs and/or would have ceased use of the olmesartan products.”

History and Facts of Benicar Complications

In June 2003, Benicar HCT was approved by the FDA for treatment of hypertension. Azor tablets was approved by the FDA in September 2007 also for use of hypertension, and Tribenzor was approved in July 2010.

Although the FDA had approved the use of these medications, in July 2013 the federal agency issued a Drug Safety Communication warning that medications that contain the blood pressure drug olmesartan medoxomil, including Tribenzor, Azor, Benicar HCT, and Benicar, can cause intestinal problems. The agency had also approved changes to be made of the drug’s labeling to include adverse effects and concerns.

Some of the findings of the FDA include the aforementioned chronic diarrhea and weight loss. Additionally, sprue-like enteropathy, a disease of the small intestine, was reported to develop within months to years of taking Benicar.

Accordingly, in the FDA’s Adverse Event Reporting System (FAERS), the agency announced that “23 serious cases in the FAERS presenting as late onset diarrhea with significant weight loss and, in some cases, with intestinal villous atrophy on biopsy.”

They had further discovered that “all patients improved clinically after discontinuation of olmesartan medoxomil, and a positive rechallenge was seen in 10 of the cases.”

Daiichi Sankyo Inc., or Daiichi Sankyo U.S., is well-known for marketing, distributing, and selling pharmaceutical drugs across the United States. Daiichi Sankyo U.S. is a subsidiary of Daiichi Sankyo U.S. Holdings, Inc., which operates as a holding company for Daiichi Sankyo Co. Ltd., a corporation which exists and runs under Japanese law, headquartered in Tokyo.

The Benicar Complications Lawsuit is Case No. 1:15-md-02606-RBK-JS, in the U.S. District Court for the District of New Jersey, Camden Vicinage.