When your doctor prescribes blood pressure medication, you expect it to help lower your blood pressure, not make you ill from the medication’s side effects. Many patients whose doctor prescribed them Benicar, generic name olmesartan medoxomil, and sold under several other brand names suffered injuries caused by the medication.
What Benicar is and what it is Prescribed For
Daiichi Sankyo, a Japanese drug manufacturer first made Benicar. The company received approval from the United States Food and Drug Administration (FDA) to market the drug in the United States in 2002. The FDA approved indication for Benicar is the treatment of high blood pressure (hypertension). The medication is available in tablets with strengths from 5 mg to 40 mg. The tablets are for oral use.
Olmesartan medoxomil belongs to the blood pressure medications classified as angiotensin II receptor antagonists. Angiotensin is a chemical your body makes that causes blood vessels to constrict. The medication blocks angiotensin from its receptor cells and prevents constriction of blood vessels that cause high blood pressure.
The drug is very popular with more than six million prescriptions written and filled in 2010. They had a worth of more than $550 million. By 2012, there were 10.9 million prescriptions written for 1.9 unique patients.
In July 2013, the Food and Drug Administration issued a drug safety communication 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. FDA has approved changes to the labels of these drugs to include this concern.”
The symptoms of this serious intestinal problem include:
- Chronic diarrhea
- Severe diarrhea
- Weight loss
- Inflammation of the Intestines
- Electrolyte imbalances
The FDA advised in this communication that if doctors can find no other cause for sprue-like-enteropathy, discontinuation of the olmesartan is best along with ordering another blood pressure medication for their patient. Discontinuation of the medication resulted in clinical improvement for all patients.
The FDA issued the safety communication after reports from 23 users of the medication identified the same symptoms. Although some required hospitalization, all reported improvement when they stopped taking the medication.
According to the FDA, the onset of these adverse effects was not immediate. Patients developed symptoms of sprue-like-enteropathy months or years after beginning olmesartan medoxomil therapy. FDA scientists suspect that the long latency period between first use of the medication and the development of symptoms of sprue-like-enteropathy is a result of delayed hypersensitivity to the drug in the intestines or a cellular immune response.
Celiac Disease or Sprue-like-Enteropathy?
Sometimes, sprue-like-enteropathy is confused with Celiac Disease. Celiac Disease is an autoimmune disorder that is genetically predisposed to this condition. The symptoms are eerily similar to that of sprue-like-enteropathy. The only treatment for Celiac Disease is a life free of gluten in the patient’s diet.
A 2012 study by the American College of Gastroenterology supported the Mayo Clinic’s earlier finding that Benicar caused sprue-like-enteropathy and not Celiac Disease. The main reason for this finding is the improvement of patients once they stopped the medication.
You Have Legal Rights
If you or a loved one took Benicar, and developed sprue-like-enteropathy, contact an experienced bad drug lawyer. These attorneys specialize in product liability lawsuits involving drug products. You may be entitled to monetary compensation for past and future medical costs, disability, past and future lost wages and pain and suffering.