FDA: Benicar Linked to Celiac Disease, Enteropathy

In July 2013, the FDA issued a safety communication to warn the public that an evaluation of medical reports submitted to its Adverse Event Reporting System (FAERS) showed “clear evidence of an association” between Benicar and a gastrointestinal (GI) condition known as sprue-like enteropathy. According to the FAERS, patients who were diagnosed with sprue-like enteropathy suffered chronic diarrhea and substantial weight loss, symptoms commonly associated with celiac disease. In its safety communication, the FDA warned that patients may not develop these symptoms until months or years after starting the drug.

Because patients may have not been properly warned about the side effects of Benicar, users who suffered intestinal problems may be able to sue the manufacturer and recover compensation for their injuries. If you have questions about your legal rights, or are interested in filing a lawsuit against the manufacturer of Benicar, we encourage you to speak with an attorney in your area.

FDA Changes Benicar’s Label to Include Risk of GI Problems

In an evaluation of reports submitted to FAERS, the FDA identified 23 serious cases of GI problems in Benicar users. These patients experienced chronic diarrhea, significant weight loss, and a symptom of celiac disease known as intestinal villous atrophy. Patients with celiac disease have problems absorbing nutrients from food and may develop villous atrophy, facing permanent erosion of the the absorption-aiding tissues (villi) in the small intestine.

According to the FDA, patients in all of the reports submitted to FAERS saw their symptoms improve after stopping use of Benicar. Nearly half of the patients reported a positive rechallenge (where symptoms reappeared when the drug was re-administered), which further supported the link between Benicar and GI problems. The safety communication also cited a study performed by the Mayo Clinic in June 2012 and an article published in The American Journal of Gastroenterology in May 2013, both of which reported results consistent with the FAERS evaluation.

The FDA also found that patients exposed to Benicar for at least two years displayed higher rates of celiac disease – a marker for enteropathy and other GI conditions – than patients who took a different ARB drug, according to data from the Mini-Sentinel pilot of the Sentinel Initiative.

Following these findings, the FDA approved updates to Benicar’s label to include the heightened risk of sprue-like enteropathy. The agency also warned patients to seek different treatment if they experience GI side effects without any other apparent cause than Benicar.

Will This Be a Class Action Lawsuit?

Attorneys believe that if lawsuits are filed against Benicar’s manufacturer, they will proceed individually and not as a class action. They will likely be handled in a procedure known as multidistrict litigation (MDL), where a large number of lawsuits making similar allegations are consolidated to a single court in front of one judge. An MDL works well for defective drug lawsuits because it helps to avoid repetitious litigation, while still allowing plaintiffs the chance to collect individual awards. 

How Much Will a Lawyer Cost?

Defective drug lawyers usually work on a contingency-fee basis. This means the attorney will not require an up-front fee, but will typically collect one-third of the award if they win the case.

What GI Side Effects Have Benicar Users Reported?

The FDA reported that Benicar is the only ARB drug that has been linked to these intestinal problems and warned that symptoms of GI illnesses may not develop until months or years after patients have started the drug.

The Class Action lawyers would like to speak with anyone who took Benicar and experienced GI side effects. These patients may be eligible to collect compensation for their pain and suffering, medical bills, and lost wages.

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