The Japan-based manufacturer of Benicar, a popular hypertension drug, is facing more than 1,700 lawsuits over serious side effects for some users of the drug that may cause long-lasting complications and hospitalization.
Daiichi Saknyo received approval from the U.S. Food and Drug Administration (FDA) in 2002 for Benicar (olmesartan medoxomil) to treat hypertension (high blood pressure). The drug relieves blood pressure by relaxing the blood vessels.
Certain Benicar users have reported serious side effects from the drug, the most prevalent of which is sprue-like enteropathy, a condition involving intestinal problems that include severe diarrhea and substantial weight loss. This condition can be long lasting and may require hospitalization. It is often mistaken for Celiac Disease, further complicating a patient’s health because of the misdiagnosis.
In July 2013, the FDA issued a warning about the link between Benicar and sprue-like enteropathy as well as other gastrointestinal illnesses. The agency approved a new warning label for the drug that would inform patients and health care providers about these potentially serious side effects in some users.
The lawsuits claim that Daiichi Saknyo knew or should have known that Benicar use causes major side effects in some patients. The plaintiffs allege that the company failed to warn consumers and medical professionals about the link between Benicar and these side effects.
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