It is an antihypertensive drug used to treat high blood pressure which may also help to reduce the chance for heart attack, stroke, and kidney disease. Olmesartan is a member of the angiotensin receptor blocker (ARB) class of medications and is combined with other medications as Benicar HCT (olmesartan/hydrochlorothiazide), Azor (olmesartan/amlodipine) and Tribenzor (olmesartan/hydrochlorothiazide/amlodipine).
Benicar and its combination drugs are manufactured by a Japanese company, Daiichi Sankyo, which has been the subject of thousands of lawsuits due to severe gastrointestinal effects which may be life-threatening.
How does Benicar work?
Benicar (olmesartan medoxomil) is an ARB antihypertensive drug which works to reduce blood pressure by blocking the angiotensin II receptor. Angiotensin II is a naturally-occurring substance that is a powerful vasoconstrictor which causes the muscles surrounding blood vessels to contract. When these muscles constrict, the blood vessel narrows and blood pressure is increased. Angiotensin II receptor blockers (ARBs) block angiotensin II from interacting with the receptor which causes vasoconstriction and as a result, blood pressure is lowered.
Benicar FDA Approval
Benicar was approved by the FDA in April of 2002 for the treatment of hypertension or high blood pressure. Because high blood pressure can contribute to other health problems, lowering blood pressure can help to prevent heart disease, heart attack, stroke, kidney disease, blindness, and other conditions.
In 2013, the prescribing information for Benicar was changed to include warnings about gastrointestinal problems that may be caused by the drug. This was required after the FDA issued a safety alert about a “sprue-like enteropathy” which may cause severe diarrhea and extreme weight loss and may require hospitalization or be life-threatening.
Benicar is approved to treat hypertension in adults and children (6 to 16 years of age). Dosage requirements vary by age and the medication is available in 5mg, 20mg, and 40mg tablets.
Benicar is often given in combination with other medications to treat high blood pressure such as diuretics, calcium channel blockers, beta blockers, and ACE inhibitors and as part of a comprehensive treatment plan which may include lifestyle changes.
Approved combination medications containing olmesartan include:
- Benicar HCT – olmesartan and hydrochlorothiazide (diuretic)
- Azor – olmesartan and amlodipine (calcium channel blocker)
- Tribenzor – olmesartan, hydrochlorothiazide, and amlodipine
Generic formulations of olmesartan and combinations containing olmesartan became available starting in October 2016.
Benicar Side Effects and Adverse Events
All medications, including Benicar, may cause side effects. Most side effects are mild to moderate and may go away with time, but others may be more severe or last for a long period of time. In some cases, Benicar side effects can become serious or may be life-threatening.
Benicar may pose a serious risk to women who are pregnant, developing fetuses and to infants. Benicar should not be used during pregnancy or in infants or children under the age of one year (12 months).
Benicar Common Side Effects
The most common side effects of Benicar include dizziness and lightheadedness which usually go away as the patient becomes used to the medication.
Common side effects can include:
- Dizziness or lightheadedness
- Back pain
- Joint or muscle pain
- Itching or rash
- A headache
- Flu-like symptoms
Symptoms which are persistent or become bothersome should be reported to a medical professional.
Benicar Severe Side Effects
Some side effects of Benicar may be more severe and may indicate a serious medical issue including low blood pressure, kidney disease, muscle breakdown (rhabdomyolysis) or high potassium levels (hyperkalemia). Taking other medications may increase the chance for severe side effects. Patients should tell their doctor or pharmacist about all of the medications they are taking.
Severe side effects may include:
- Vertigo or blurry vision
- Chest or abdominal pain
- Rapid heartbeat or palpitations
- Shortness of breath or coughing
- Muscle weakness or pain
- Brown colored or bloody urine
- Swelling in extremities or abdomen
Severe side effects should be reported to a medical professional right away. Symptoms of allergic reaction or angioedema such as swelling of the throat, tongue or lips should be treated as an emergency.
Benicar Serious Adverse Events
Benicar may cause or contribute to medical conditions which may require hospitalization, result in permanent injury or are life-threatening and may result in death.
Benicar Gastrointestinal Problems
Benicar has been associated with a severe gastrointestinal condition known as “sprue-like enteropathy” which causes severe and chronic diarrhea and significant weight loss which may lead to malnutrition. A 2012 study conducted by the Mayo Clinic examined the link between olmesartan and the GI illness which had similar symptoms to celiac disease. Patients identified in the study were taking olmesartan had chronic diarrhea that lasted for more than one year and experienced weight loss averaging 40 pounds.
This research was confirmed at the 2012 meeting of the American College of Gastroenterology where an additional 40 patients were identified. In addition to diarrhea and weight loss, some patients also exhibited degradation to the lining of the small intestine, known as villous atrophy, which decreases the ability to absorb nutrients. Patients who become malnourished may experience additional health problems including muscle wasting, dehydration, and organ damage, and may be at risk for death.
In 2013, the FDA issued a safety alert regarding olmesartan and sprue-like enteropathy. The agency required that information regarding GI illness be added to prescribing information for all olmesartan products. Sprue-like enteropathy may develop slowly and may begin months or years after Benicar is started. Because it has similar symptoms to celiac disease, it may be misdiagnosed but adopting a gluten-free diet will not reduce the symptoms. The FDA recommends that patients who develop sprue-like enteropathy should stop taking Benicar.
Benicar Kidney Failure
Patients who have high blood pressure are at risk for developing kidney disease and lowering blood pressure helps to reduce that risk. Some patients, however, have developed worsened kidney problems as a result of taking Benicar due to its effect on the renin-angiotensin system. Typically, these patients have a preexisting condition such as congestive heart failure (CHF) or compromised renal function but any symptoms of kidney failure should be reported to a medical professional.
Symptoms of kidney failure may include swelling of hands or feet (edema), swelling of the abdomen (ascites), inability to produce urine (oliguria), fatigue, shortness of breath and nausea.
Benicar in Pregnancy and Infants
Benicar may cause injury to kidneys in developing fetuses which may result in fetal death. Drugs that act on the renin-angiotensin system may reduce fetal renal function when taken during the second and third trimester. Effects on the pregnancy and fetus may include oligohydramnios (low amniotic fluid), skull hypoplasia (poor bone formation in the skull), skeletal abnormalities, fetal hypotension, and fetal death. Though it has not been proven, Benicar may also have harmful effects on infants under the age of one year.
The FDA has required that Benicar and drugs containing olmesartan carry a “black box warning” against using the medication during pregnancy or in infants under the age of one (12 months). A black box warning or “boxed statement” is the most severe warning that can be issued for a medication and indicates serious or life-threatening concerns. The Benicar black box warning indicates that patients who become pregnant while on Benicar should speak with their doctor right away about management of their hypertension.
Benicar Heart-related Deaths
Two clinical trials showed that diabetic patients who took Benicar had a higher risk for cardiac death than those taking a placebo. Based on these results, the FDA conducted a four-year review regarding a suspected increase in cardiac-related deaths. The agency concluded that there was no clear evidence that Benicar was related to an increased risk for cardiac death.
Daiichi Sankyo has faced multiple Benicar lawsuits due to injuries or deaths that may have been caused by the medication. In 2017, Daiichi agreed to settle more than 2,000 cases that had been consolidated in federal court in New Jersey for over $300 million. Other lawsuits may still remain in state and local courts and more lawsuits may be expected.
Notwithstanding claims relating to this product, the drug/medical device remains approved by the U.S. FDA.
- Severe Spruelike Enteropathy Associated With Olmesartan, Mayo Clinic Proceedings 8/2012
- Olmesartan and Drug-Induced Enteropathy, Pharmacy and Therapeutics 1/2014
- Benicar Prescribing Information, RxList 5/2018
- FDA Drug Safety Communication: FDA approves label changes to include intestinal problems (sprue-like enteropathy) linked to blood pressure medicine olmesartan medoxomil, U.S. Food and Drug Administration 7/2013
- Daiichi’s Benicar Pact Brings Payout Over Drugs to $339 Million, Bloomberg 8/2017