August 17, 2015 — The number of federal lawsuits involving gastrointestinal side effects of Benicar has skyrocketed from just 70 lawsuits in June to 990 lawsuits as of August 17.
The U.S. Judicial Panel on Multidistrict Litigation (JPML) released those statistics (PDF) in a report today.
The litigation has been centralized in New Jersey (MDL No. 2606) under U.S. District Judge Robert B. Kugler. When the litigation was established in April, only 15 lawsuits had been filed.
Drug-makers Daiichi Sankyo Inc. and Forest Laboratories Inc. are accused of failing to warn about sprue-like enteropathy, an illness that causes watery diarrhea, dehydration, malnutrition, severe weight-loss, and nausea.
Lawsuits allege that some marketing materials for Benicar were misleading because they made unsubstantiated claims about its effectiveness. Plaintiffs also claim some studies of Benicar’s side effects were inadequate.
It was not until after Benicar had been prescribed to nearly 2 million patients that doctors from the Mayo Clinic linked it to the illness. Many victims were misdiagnosed with Celiac disease (gluten allergy) and suffered from chronic diarrhea for years before discontinuing Benicar.
In July 2013, the FDA issued a Safety Communication about sprue-like enteropathy and ordered label updates on Benicar to warn about the risk. The FDA identified 23 serious case reports in its database of adverse events.
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