Benicar (olmesartan medoxomil) is a popular blood pressure medication sold by Daiichi Sankyo, Inc. It has been linked to a rare and severe gastrointestinal disorder called sprue-like enteropathy. The disorder can be life-threatening. It is often misdiagnosed as Celiac disease because it has similar symptoms including chronic diarrhea. Olmesartan is also sold under the brand names Benicar HCT, Azor, and Tribenzor, and is sold in generic form.
Sprue-like enteropathy causes villous atrophy, preventing the intestines from properly absorbing nutrients and resulting in malnutrition. If the disorder is left untreated, malnutrition can become so severe that it becomes life-threatening. Treatment is often delayed because due to misdiagnosis, which can result in serious complications. Benicar can cause permanent injuries.
Symptoms of sprue-like enteropathy include:
- Severe, chronic diarrhea
- Substantial weight loss
- Severe malnutrition
- Abdominal pain
Studies Link Benicar to Sprue-Like Enteropathy
The Mayo Clinic submitted data to the FDA, in 2012, showing a link between Benicar and sprue-like enteropathy. Between 2008 and 2011 the clinic treated 22 patients with life-threatening gastrointestinal symptoms. It was initially believed that the patients suffered from Celiac disease, but they did not improve with treatment. After tests for Celiac came back negative, doctors noticed that the common thread between the patients was olmesartan use. When the drug was discontinued the patients improved.
In October, 2012, the American College of Gastroenterology discovered 40 more cases of sprue-like enteropathy connected to olmesartan-based drugs.
Benicar has not been recalled, but in 2013, the U.S. Food and Drug Administration (FDA) published a safety announcement warning the Benicar and other drugs containing olmesartan can cause sprue-like enteropathy, and that the warning labels would be changed to reflect the danger.
The FDA advises that patients should switch to a different medication to treat high blood pressure if they experience symptoms of sprue-like enteropathy and no other cause is found.
Other Benicar Side Effects and Risks
Benicar should not be taken by pregnant women because it can cause injury or death to the fetus. Other side effects can include:
- Peripheral edema
- Chest pain
- Irregular heart beat
- Abdominal pain
- Liver impairment
- Kidney problems, including failure
- Hair loss
So far, nearly 1,000 lawsuits have been filed against Benicar makers Daiichi Sankyo, Inc., Daiichi Sankyo Co. Ltd., and Forest Laboratories Inc. on behalf of people who allege that they were harmed by using the dangerous drug.