FDA Adds GI Warning to Benicar Label
Benicar, or Olmesartan, falls within a drug class known as angiotensin II receptor blockers (ARBs). In 2002, the FDA approved its use for hypertension because it lowers blood pressure, improves the flow of blood, and keeps blood vessels from narrowing.
Benicar has been linked to a gastrointestinal condition known as sprue-like enteropathy, which may not develop until months or years after starting to use the drug. Often this requires hospitalization and patients typically have to have an endoscopy with biopsy to determine the extent of the damage to the small intestine.
In 2013, the FDA ordered the makers of the drug to include a warning about the risk of this condition.
Multidistrict Litigation (MDL) for Benicar Lawsuits
To handle the growing number of lawsuits, a multidistrict litigation (MDL) has been set up in the federal court system in the District of New Jersey. An MDL centralizes trial proceedings before one judge, simplifying the process because a number of cases can be handled by the same experienced judge and in the same court.
Transfer Order (PDF), filed April 3, 2015.
GI Side Effects of Benicar
Sprue-like enteropathy may cause:
- Chronic diarrhea
- Substantial weight loss
- Misdiagnosis of Celiac Disease
- Gastrointestinal damage
- Villous atrophy
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The FDA’s Adverse Event Reporting System found 23 serious cases documenting late-onset diarrhea with significant weight loss and, in some cases, intestinal villous atrophy on biopsy. All patients improved after discontinuing use of the drug. The FDA reports that sprue-like enteropathy has not been detected with other angiotensin II receptor blockers other than Olmesartan.