July 3, 2014 — Daiichi Sankyo, the manufacturer of the blood-pressure drug Benicar (olmesartan), has been hit with a lawsuit from a California woman who accuses the drug-maker of failing to warn about the risk of enteropathy.
The lawsuit (PDF) was transferred to the U.S. District Court for the Southern District of California on June 17. The plaintiff, Susanne Ambler, was prescribed Benicar by her doctor in San Diego, California, in the last four years.
While taking the recommended dose, she developed sprue-like enteropathy and/or lymphocytic colitis, microscopic colitis, or collagenous colitis, manifested by chronic diarrhea, severe weight loss, nausea, vomiting, malnutrition, and dehydration.
Exactly one year ago today, the U.S. Food and Drug Administration (FDA) warned about the risk of enteropathy from olmesartan, an ingredient in Benicar, Benicar HCT, Azor, Tribenzor, and generics.
The label updates were ordered after a review of adverse events identified 23 cases describing late-onset diarrhea with significant weight-loss, and in some cases, intestinal villous atrophy on biopsy. These symptoms are very similar to Celiac disease (gluten intolerance).
Several lawsuits have been filed by people who were misdiagnosed with Celiac disease and suffered for years before realizing that Benicar was to blame. Although symptoms of enteropathy usually resolve when Benicar is discontinued, severe intestinal damage can reduce digestive capacity.
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