Benicar (olmesartan) is a medication used to treat high blood pressure which has been linked to a serious side effect known as sprue-like enteropathy. Daiichi-Sanyo, Benicar’s manufacturer has faced numerous Benicar lawsuits for injuries caused by olmesartan.
Daiichi-Sankyo, manufacturer of Benicar and Benicar HCT has faced thousands of lawsuits filed by people who have suffered medical injury due to the medication. The company reached a $300 million settlement to resolve over 2,300 Benicar lawsuits in 2017 but more lawsuits may remain in the court system.
|Dosage form(s)||5mg tablet|
|Normal dosage||Adults – 20 to 40mg olmesartan daily|
children 6 to 16 years of age – dosage by weight
The active ingredient in Benicar, olmesartan medoxomil is also present in other antihypertensive drugs including:
- Benicar HCT – olmesartan/hydrochlorothiazide (diuretic)
- Azor – olmesartan/amlodipine (a calcium channel blocker)
- Tribenzor – olmesartan/amlodipine/hydrochlorothiazide (diuretic)
Drug Warning: Benicar
Benicar and Benicar HCT are prescription medications used to lower blood pressure (hypertension). Benicar works by blocking activity of a potent, naturally occurring vasoconstrictor substance known as angiotensin-II and is known as an “angiotensin-II receptor blocker” or ARB.
Benicar was developed by Japanese pharmaceutical company Daiichi Sankyo and was approved by the U.S. Food and Drug Administration (FDA) in April 2002. Daiichi Sankyo went on to spend nearly $1 billion dollars promoting Benicar and Benicar HCT by boasting its effectiveness and safety for high blood pressure patients. According to the FDA, approximately 10.6 million prescriptions were dispensed of the drug in 2012 alone and in 2014, the medication brought the company over $2.6 billion in revenue.
Benicar FDA Warnings
The FDA warned in July of 2013 that drugs containing olmesartan, including Benicar, , Benicar HCT, Azor, and Tribenzor may cause intestinal problems known as sprue-like enteropathy”, which induces similar symptoms to celiac disease. In some cases, patients have been hospitalized for several months due to the disorder. This warning required that information be added to prescribing information for Benicar and other products containing olmesartan, regarding the threat of sprue-like enteropathy.
The 2013 FDA warning was issued subsequent to conclusion of a three-year Mayo Clinic study in which concluded that many patients who had used the drug exhibited symptoms of celiac disease actually had a condition induced by the medication. “In 22 patients, each had a substantial improvement or indeed remissions of their symptoms with withdrawal of the drug” according to Joseph A. Murry, MD, a Gastroenterologist for the Mayo Clinic.
Daiichi Sankyo had been the subject of prior warnings by federal and state investigators including the U.S. Department of Justice for illegal payments that had been made to doctors in exchange for prescribing Benicar. The company was ordered to pay $40 million in fines for illegal marketing between 2005 and 2011.
Benicar Sprue-like Enteropathy
Sprue-like enteropathy is a disorder which affects the gastrointestinal system and may cause:
- Severe nausea and vomiting
- Chronic diarrhea
- Excessive weight loss
- Nutritional disorder
- Misdiagnosis of celiac disease
Because people who develop sprue-like enteropathy may be unable to absorb nutrients, the condition may be fatal. Many patients who are hospitalized with the disorder, must be placed on feeding tubes or administered IV nutrition to restore nutritional balance.
Other Benicar Side Effects
In addition to the life-threatening condition of sprue-like enteropathy, Benicar may cause side effects such as:
- Chest pain
- Hair loss
- Changes in kidney or liver functioning
Severe or bothersome side effects should be reported to a healthcare practitioner.
Benicar Black Box Warning
Use of Benicar and other ARB medications has been linked to a side effect which may cause birth defects in women who use the medication while pregnant. The FDA has required that information regarding the side effect be printed as a black box or boxed statement at the top of prescribing information for Benicar and other products containing olmesartan. Benicar’s black box warning states that olmesartan may cause injury and death to the developing fetus due to action on the renin-angiotensin system.
The medication is only approved to treat children and adults over the age of 6 years old and should not be used in those younger than 1 year of age due to possibility of harm on developing kidneys and organs.
Benicar Settlement Attorneys
In 2017, Daiichi Sankyo set aside $300 million to settle over 2,300 lawsuits filed by patients who had suffered injury due to Benicar. Benicar lawsuits were filed by patients who developed serious GI issues including but not limited to:
- Excessive Weight Loss
- Chronic diarrhea
- Or who have been mis-diagnosed with Celiac disease
Other manufacturers who market drugs containing olmesartan may also be liable and Daiichi Sankyo may still be facing more Benicar lawsuits.
Each case is unique but past medical injury settlements have included compensation for medical costs, lost wages, and pain and suffering. People or loved ones of those who suffered from a severe GI illness after taking Benicar should seek legal assistance from a Benicar lawyer.
Notwithstanding claims relating to this product, the drug/medical device remains approved by the U.S. FDA.