What is Benicar?
Benicar is a prescription drug used to treat patients with high blood pressure (hypertension). It is manufactured by Japan-based pharmaceutical company Daiichi Sankyo and was first approved for use by the U.S. Food and Drug Administration (FDA) on April 25, 2002. It can be used alone or with other medications that treat hypertension.
Benicar belongs to a class of drugs called angiotensin II receptor blockers (ARBs). These drugs block a natural substance in the body called angiotensin II, which can narrow blood vessels. Narrower vessels can increase blood pressure and make it harder for the heart to pump blood throughout the body. ARBs help to widen these vessels, thereby lowering blood pressure.
The active ingredient in Benicar, olmesartan medoxomil, is one of several AGBs on the market today. As of 2012, nearly 11 million prescriptions were written for olmesartan-containing drugs to nearly two million patients, according to the FDA.
Serious Side Effects of Benicar
Since coming on the market nearly 14 years ago, Benicar has been shown to cause a serious gastrointestinal problem known as sprue-like enteropathy in some patients.
In July 2013, the FDA issued a warning that olmesartan can cause this gastrointestinal problem and required Daiichi Sankyo update the Benicar label to include the warning. The warning is required on all drugs containing olmesartan medoxomil, including Benicar, Benicar HTC, Azor, Tribenzor and other generics.
Sprue-like enteropathy can cause severe, chronic diarrhea and substantial weight loss. Patients may also develop intestinal villous atrophy, which causes the fingerlike projections in the small intestine responsible for nutrient absorption to erode away.
Patients may not develop enteropathy for months or years after starting Benicar. In some cases, the symptoms are severe enough to require hospitalization.
Because the symptoms of sprue-like enteropathy mimic those of Celiac disease, a hypersensitivity to gluten that affects the small intestine, many patients have been misdiagnosed with Celiac disease.
Clinical Trials Show Link Between Drug and Gastrointestinal Problems
The FDA examined adverse events reported by patients taking olmesartan and found 23 serious cases of late-onset diarrhea with significant weight loss and, in some cases, intestinal villous atrophy. All of these patients improved after they stopped taking the drug.
A clinical trial published by the Mayo Clinic in 2012 examined 22 other patients taking olmesartan who suffered from sprue-like enteropathy and intestinal villous atrophy. Many of these patients were misdiagnosed as having Celiac disease. None of the patients’ symptoms improved when following a gluten-free diet, but when the patients stopped using olmesartan, their symptoms improved.
Because of these trials, the FDA issued a warning and required a label change for Benicar and other olmesartan drugs to include the possibility of patients developing sprue-like enteropathy.
No other ARB drug has been shown to cause enteropathy, only those containing olmesartan, including Benicar, Benicar HTC, Azor, Tribenzor and other generics.
People with high blood pressure who have taken Benicar and have suffered from sprue-like enteropathy may be able to participate in a class action lawsuit to hold Daiichi Sankyo responsible for not adequately warning users of the potential side effects. Contact the Hood National Law Group today for a free case evaluation by calling 1-800-214-1010 or use the form on the right-hand side of the screen.