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Benicar Patients Claim Blood Pressure Medication Caused them Severe Diarrhea, Sues Drug Maker

Filed February 27th, 2014 Laurie

A series of lawsuits will be launched against the New Jersey-based drug maker Daiichi Sankyo Inc. later this week that allege the company’s blood pressure drug Benicar caused patients severe diarrhea and other serious injuries.

So far, a total of six Benicar lawsuits have been filed in New Jersey, all of which have been removed to federal court. At least three more lawsuits are expected to be filed by Friday, according to Law360.com.

The lawsuits allege that Benicar was designed in a defective manner, and that Daiichi failed to warn patients that the drug could cause debilitating diarrhea and nausea that could result in malnutrition, dehydration, and weight loss, Law360.com reported.

The U.S. Food and Drug Administration (FDA) ordered Daiichi to add a warning label about the risk of the intestinal condition, known as sprue-like enteropathy, to Benicar’s label in July 2013. Mayo Clinic researchers made the link between the drug and sprue-like enteropathy in June 2012. The clinic saw 22 patients with symptoms suggestive of celiac disease between 2008 and 2012, but antibody blood tests showed the disease was not present in their bodies. All of the patients, however, were taking Benicar at the time, according to MedPageToday.com.

The 22 patients seen by Mayo Clinic researchers were on average 69 years old and had suffered chronic diarrhea for an average of 19 months. The patients gained an average of 27 pounds when their doctors discontinued the drug, MedPageToday.com reported.

The FDA decided to approve the warning on Benicar’s label upon evaluating its Adverse Event Reporting System, published literature case series, information from the Mini-Sentinel pilot of the Sentinel Initiative, and information from the CMS Medicare database, according to MedPageToday.com.

One of the patients suing Daiichi claims he has spent more than 100 days in the hospital over the last four years due to injuries and side effects caused by Benicar. He says he must use a feeding tube, has a compression fracture in his back, and developed cataracts in both eyes as the result of either taking Benicar or treatments related to his diarrhea, Law360.com reported.

Legal experts say hundreds, perhaps thousands of Benicar lawsuits are expected to pop up around the country over time. Approximately 1.9 people received a prescription for Benicar or a similar drug in 2012 alone. It is likely that many Benicar patients are experiencing chronic diarrhea, but they don’t know there is a connection between the two, according to Law360.com.

In addition to Daiichi, the lawsuits also name Forest Laboratories Inc., which allegedly promoted Benicar; Daiichi Sankyo Co. Ltd., which is Daiichi’s parent company, and other Daiichi entities.

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