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
- Dehydration
- Chronic diarrhea
- Nausea and vomiting
- Malnutition
- Significant weight loss
- Abdominal pain
- Angioedema (rapid swelling of the skin)
- Chest pain
- Hair loss and rashes
- Irregular heart beat
- Arthritis
Benicare Lawsuits
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.