Benicar Drug Side Effects and Injury Lawsuits

The U.S. Food and Drug Administration has warned that patients with high blood pressure taking Benicar could suffer from serious side effects, including chronic diarrhea, unusual weight loss, and severe gastrointestinal problems.

Lieff Cabraser represents patients prescribed Benicar who have experienced chronic diarrhea with substantial weight loss, severe gastrointestinal problems, and the life-threatening conditions of sprue-like enteropathy and villous atrophy in litigation against Japan-based Daiichi Sankyo, Benicar’s manufacturer, and Forest Laboratories, which marketed Benicar in the U.S.

The complaints allege that Benicar was insufficiently tested and not accompanied by adequate instructions and warnings to apprise consumers of the full risks and side effects associated with its use. Plaintiffs recently filed motions to compel defense to produce additional discovery. The judge ruled for the plaintiffs, and discovery is ongoing.

What is Benicar (aka Azor, Tribenzor)?

Benicar is the brand name for the prescription drug olmesartan, a medication used to reduce blood pressure and hypertension (chronic high blood pressure). Olmesartan is also contained in the drugs sold under the names of Benicar HCT, Tribenzor and Azor. Benicar is made by the Japanese company Daiichi Sankyo and co-promoted in the U.S. by Forest Laboratories.

Has Benicar Been Widely Prescribed?

Yes. According to the U.S. Food and Drug Administration, over ten million Benicar prescriptions were made to approximately two million patients in the U.S. in 2012.

What are the Benicar side effects?

Patients taking Benicar under the recommended dosage have experienced major complications, including:

  • severe, chronic diarrhea with substantial weight loss;
  • sprue-like enteropathy;
  • villous atrophy; and
  • lymphocytic, collagenous and/or microscopic colitis.

Sprue-like enteropathy and villous atrophy are both conditions involving destruction of the intestinal lining that are characterized by severe, chronic diarrhea, malabsorption, and substantial weight loss. These conditions often result in repeat hospitalizations, and in some cases cause secondary complications such as renal failure. The conditions can develop months to years after starting Benicar use.

Patients with Benicar-induced gastrointestinal problems are often misdiagnosed with celiac disease.

Has Benicar been recalled?

No. However, in July 2013, the FDA required the addition of warnings regarding the risk of sprue-like enteropathy and villous atrophy to the drug labels of Benicar, Benicar HCT, Tribenzor and Azor.

What do the Benicar lawsuits charge?

Benicar lawsuits filed by patients represented by Lieff Cabraser charge that Benicar was insufficiently tested and not accompanied by adequate instructions and warnings to apprise patients of the full risks and side effects associated with Benicar use. Daiichi Sankyo and Forest Laboratories, the maker and distributor of Benicar, were allegedly aware that long-term use of Benicar was likely to cause a host of serious and, in some cases, life-threatening diseases, yet failed to adequately warn physicians and patients of these risks.

What are the legal duties that drug manufacturers owe to patients?

Drug makers have a duty to warn patients and doctors of all serious side effects from their medications.

The law in most states provides several personal injury claims for persons who have been seriously injured by a prescription drug with dangerous and undisclosed side effects.

These claims include strict liability for a defective product, breach of warranty, negligence, and misrepresentation. Damages sought against pharmaceutical companies for dangerous drug side effects and injuries include:

  • Physical pain and suffering, mental anguish and physical impairment;
  • Medical expenses, past and future; and
  • Loss of earnings and/or earning capacity.

In the case of a patient’s death, the family of the victim may file a wrongful death action and seek damages.

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