Benicar (Olmesartan) Litigation

Blood Pressure Meds & Gastrointestinal Injuries

Studies have established a link between the use of blood pressure medications containing the compound known as olmesartan and the development of serious gastrointestinal issues. Common blood pressure medications which contain olmesartan include: Benicar, Benicar HCT, Amor, and Tribenzor. All four olmesartan drugs were approved for the treatment of hypertension (high blood pressure) and have been widely prescribed in the United States. Additionally, all four olmesartan drugs are manufactured by the Japanese corporation, Daiichi Sankyo.  

What is Olmesartan?

Olmesartan medoxomil is the active ingredient found in Benicar, Benicar HCT, Azor, and Tribenzor.  Olmesartan medoxomil has been approved for the treatment of hypertension.  However, recent studies have found a link between the ingestion of olmesartan and the development of serious, and sometimes life threatening, gastrointestinal injuries.

Injuries Caused by Olmesartan Ingestion

Recent studies have established an association between the ingestion of olmesartan drugs, such as Benicar, Benicar HCT, Azor, and Tribenzor, and the development of serious gastrointestinal injuries such as olmesartan induced enteropathy.  Olmesartan induced enteropathy (also referred to as sprue-like enteropathy) results in serious injuries including, but not limited to:

- Chronic Diarrhea
- Unexpected and Uncontrollable Weight Loss
- Nausea
- Vomiting
- Severe Abdominal Pain
- Malnutrition
- Kidney Damage/Failure
- Dehydration
- Malabsorption
- Villous Atrophy/Blunting
- Microscopic Colitis
- Death

First Discovery of Gastrointestinal Injuries

World renowned gastroenterologist, Dr. Joseph Murray, first discovered a potential connection between olmesartan and severe gastrointestinal problems when two patients he was treating for severe gastrointestinal symptoms at the Mayo Clinic experienced significant improvement after discontinuing olmesartan treatment. Dr. Murray then began assessing additional cases of unexplained severe gastrointestinal symptoms. In total, Dr. Murray studied 22 patients with unexplained severe sprue-like enteropathy while taking olmesartan therapy. All 22 patients tested negative for Celiac disease and did not respond to a gluten free diet. However, when olmesartan therapy was ceased all 22 patients exhibited a remarkable decrease in symptoms. As a result, Dr. Murray found an association between the development of severe sprue-like enteropathy and the ingestion of olmesartan containing drugs.  

A complete copy of Dr. Murray's study can be found at: http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3538487/

Changes to the Labeling of Olmesartan Drugs

Following the Dr. Murray's study, the FDA began reviewing all data and studies pertaining to olmesartan drugs.  Following the FDA's investigation the FDA issued a safety announcement in July of 2013 warning that the blood pressure drug olmesartan medoxomil (marketed as Benicar, Benicar HCT, Azor, Tribenzor, and generics) can cause intestinal problems known as sprue-like enteropathy. Additionally, the FDA required the label of all olmesartan drugs to be updated to include these concerns. However, the label change implemented by the makers of Benicar, Benicar HCT, Azor, and Tribenzor still fails to fully inform and warn consumers of all the dangerous and serious side effects associated with the use of olmesartan products.

To view the FDA safety announcement concerning olmesartan products please visit: http://www.fda.gov/Drugs/DrugSafety/ucm359477.htm