As the number of Benicar lawsuits grows, a multidistrict litigation, or MDL, has been established in the federal court system in the District of New Jersey, according to a transfer order filed April 3. It is believed that the cases will benefit from centralized trial proceedings before one judge, who will coordinate discovery and direct the preparation of the cases for trial. It is anticipated that several thousand cases will be filed over the coming months on behalf of those who have suffered adverse effects from using Benicar.
What is Benicar?
Benicar (olmesartan) is part of the class of drugs known as angiotensin II receptor blockers, or ARBs, was approved by the U.S. Food and Drug Administration in 2002 for the treatment of hypertension. Olmesartan keeps the blood vessels from narrowing, lowers blood pressure, and improves the flow of blood.
Benicar is used to treat high blood pressure in adults and children at least six years old. Lowering high blood pressure helps prevent strokes, heart attacks, and kidney problems.
In 2013, the FDA ordered Benicar’s maker to add a warning about the risk of an intestinal condition known as sprue-like enteropathy, which may cause:
- Chronic diarrhea
- Substantial weight loss
- Misdiagnosis of Celiac Disease
- Gastrointestinal damage
- Villous atrophy
- Colitis
The enteropathy may develop months or even years after starting olmesartan, and frequently requires hospitalization. Patients routinely have to have an endoscopy with biopsy to determine the extent of the damage to their small intestine.
The 2013 warning was based on 23 serious cases documented in the FDA’s Adverse Event Reporting System, which found late-onset diarrhea with significant weight loss and, in some instances, intestinal villous atrophy on biopsy. All the patients improved clinically after discontinuing Benicar use. According to the FDA, sprue-like enteropathy has not been detected with other angiotensin II receptor blocker drugs other than olmesardan.