Earlier this month, three lawsuits were filed against drug maker Daiichi Sankyo alleging that the company’s blood pressure drug Benicar (olmesartan) caused severe diarrhea and other serious injuries to those taking the drug. Additional suits are expected to be filed in New Jersey this week.
Legal complaints claim that Benicar, produced by New Jersey-based Daiichi, is of defective design, and that the company failed to warn users that Benicar could cause chronic diarrhea, nausea, malnutrition, dehydration, and weight loss, Law360 reports.George Williams, who filed one of the first suits, said in his legal complaint that he has been hospitalized for more than 100 days over the past four years because he took Benicar. He says he now must use a feeding tube. He suffered a compression fracture in his back and has developed cataracts in both eyes as the result of taking Benicar or as a result of treatments for his severe diarrhea, according to Law360.
In July 2013, the U.S. Food and Drug Administration (FDA) mandated changes to Benicar’s label, warning that the drug could cause spruelike enteropathy, a condition resembling celiac disaease, whose symptoms include severe and chronic diarrhea and substantial weight loss. This condition can develop months or even years after an individual starts taking olmesartan, according to Law360. At the time of the warning, the FDA had identified 23 serious cases of late-onset diarrhea among users of the drug in its MedWatch adverse event reporting system. According to Williams’s legal complaint, in 2012, an estimated 1.9 million people were prescribed Benicar – an angiotensin II receptor antagonist – or a similar drug. Many people taking Benicar and experiencing chronic diarrhea “don’t know the connection between the two,” said an attorney involved in the litigation.
Daiichi Sankyo and its Japanese parent company have been named as defendants in the lawsuits, as well as Forest Laboratories Inc., which allegedly promoted Benicar alongside Daiichi, according to Law360.