Nearly 67 million Americans are prescribed Benicar to treat their high blood pressure.
After research surfaced linking it to severe gastrointestinal side effects, the Food and Drug Administration ("FDA") required a warning label, a flood of "failure to warn" lawsuits ensued, and Benicar manufacturer Daiichi Sankyo entered into a $39 million settlement agreement with the United States Department of Justice.
What is Benicar?
High blood pressure medication "Benicar" is in a class of drugs known as "angiotensin II receptor blockers" ("ARB"), the active ingredient in which lowers the body’s blood pressure by keeping blood vessels dilated.
Also marketed as "Benicar HCT", "Azor "and "Tribenzor", Benicar is manufactured by Daiichi Sankyo and received FDA approval on April 25, 2002.
In 2012 alone, over 1.9 million patients were prescribed Benicar from which Daiichi Sankyo received billions in sales revenue.
Bennicar Side Effects
After years on the market, research surfaced linking Benicar patients to serious and deadly gastrointestinal complications including:
- Sprue like enteropathy (a disease with Celiac-like symptoms)
- Vinous atrophy (damages small intestines ability to absorb nutrients)
- Kidney problems and failure
- Liver impairment
- Chronic diarrhea
- Nausea and vomiting
- Significant weight loss
- Abdominal pain
- Angioedema (rapid swelling of the skin)
- Chest pain
- Hair loss and rashes
- Irregular heart beat
After research surfaced linking Benicar to severe side effects, in April 2014, the FDA ruled that Benicar required a label warning associating it with specific and significant gastrointestinal ailments.
Shortly thereafter, a flood of "failure to warn" lawsuits ensued and, in early 2015, Daiichi Sankyo entered into a settlement agreement with the United States Department of Justice.
Specifically, to resolve allegations that it paid kickbacks to induce physicians to prescribe Benicar over other ARBs in violation of the False Claims Act, Daiichi Sankyo agreed to pay $39 million.