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Approved in 2002, Benicar is a hypertension medication used to lower high blood pressure. Yet, studies have found that it and its generic counterpart, olmesartan, may be linked with sprue-like enteropathy, a condition resulting in malnutrition and weight loss.

Background

The drug, made by Daiichi Sankyo and marketed by Forest Laboratories, is part of a class called angiotensin II receptor blockers (ARB). Daiichi, upon the drug’s introduction, spent about $1 billion to claim it was safer and stronger than others in its class.

However, a decade later, a study published in Mayo Clinic Proceedings pointed out a link between Benicar’s use and sprue-like enteropathy. During, researchers examined 22 patients from 2008 to 2011. Once patients stopped taking Benicar, Benicar HCT, Azor, Tribenzor, and generics, 18 patients saw symptoms improve.

Out of the group, all 22 experienced chronic diarrhea and weight loss while on Benicar, and 63 percent, or 14 patients, had to be hospitalized.

On July 3, 2013, the FDA issued a warning about the association. In reviewing its Adverse Event Reporting System, it found a link between Benicar usage and sprue-like enteropathy – a correlation that didn’t exist for other ARB drugs.

Data indicated patients may start to show symptoms of sprue-like enteropathy at any time during treatment, including:

  • Chronic diarrhea
  • Weight loss
  • Gastrointestinal problems, including colitis

Further, patients may develop another similar condition, villous atrophy, a disorder that changes the intestines’ texture. What happens over time is, this organ can’t absorb nutrients as well, and the patient becomes malnourished.

Yet, symptoms may emerge four to six months into treatment and last as long as the patient takes the medication. Compounding to this, patients end up hospitalized from dehydration, chronic diarrhea, and malnutrition, while doctors, unaware of the correlation, misdiagnose them with celiac disease or another intestinal issue.

Lawsuits

Less than a year after the FDA issued its warning, patients started coming forward. Now, the state court in New Jersey has 1,077 pending mass tort cases, and that amount is expected to grow.

Along with this lawsuit, the Department of Justice recently reached a settlement with Daiichi Sankyo. The initial claim accused the company of Medicare fraud and of giving kickbacks to doctors – a practice violating the False Claims Act.