Benicar (olmesartan medoxomil) is a prescription drug used to treat high blood pressure. People with untreated high blood pressure face an increased risk of heart attack and stroke. Medications can help reduce risks but may have side effects.
The FDA approved Benicar (olmesartan medoxomil) in 2002 to treat high blood pressure (hypertension). It is manufactured and marketed by Japanese drug maker Daiichi Sankyo. Benicar can be used alone or in combination with other drugs to help lower a patient’s blood pressure by keeping blood vessels dilated (open).
Benicar is part of the angiotensin II receptor blocker (ARB) drug class. This class of drugs helps to lower blood pressure by blocking the hormone that tightens blood vessels. Blood pressure rises as vessels constrict. While it’s normal for blood pressure to rise and fall throughout the day, health problems can develop for individuals whose blood pressure remains high for a longer period of time.
For patients suffering from high blood pressure, taking a medication, such as Benicar, can reduce the risk of heart attack and stroke. High blood pressure usually has no accompanying symptoms, so many people are unaware that there’s even a problem. But high blood pressure left unchecked greatly increases a person’s risk for heart disease and stroke, the first and third leading causes of death in the United States, respectively.
The Centers for Disease Control and Prevention (CDC) estimated that 75 million adults are dealing with high blood pressure in the United States. It affects approximately one in every three adults. Only half of those individuals are controlling their condition. Seven in 10 of those adults are controlling their blood pressure with medication. These individuals are sometimes prescribed a medication such as Benicar or one of its sister drugs containing the ingredient olmesartan.
But in 2013, the FDA released a safety announcement warning the public that Benicar also has the potential to cause intestinal problems known as sprue-like enteropathy. Symptoms of sprue-like enteropathy are usually more commonly associated with celiac disease, an immune disorder that results in sensitivity to gluten and contributes to malabsorption and gastrointestinal (GI) problems. But drug-induced enteropathy is also a possibility, as is the case with olmesartan-induced enteropathy, resulting in severe, chronic diarrhea and substantial weight loss within months to years after beginning use of the medication.
Benicar is indicated for the treatment of hypertension (high blood pressure) and is used to lower blood pressure. Elevated blood pressure levels put an individual at a greater risk of experiencing heart attack and stroke.
Benicar can result in complications for fetuses, especially in the second and third trimesters, and some of these complications can be fatal. Also, the drug has not been tested on children under 1. Other individuals can experience
adverse reactions when taking Benicar.
Medications containing olmesartan do not come without risks. Benicar side effects such as sprue-like enteropathy can be severe. Symptoms include severe, chronic diarrhea and substantial weight loss. Benicar can also result in fetal toxicity and is not recommended for women who are pregnant, especially in the second and third trimesters.
A black box warning appears on a prescription drug’s label when the FDA wants to call attention to serious or life-threatening risks associated with its use. Benicar (olmesartan medoxomil) contains one of these warnings for fetal toxicity. The label says Benicar should be discontinued as soon as possible after pregnancy is detected. It further warns that drugs that act directly on the physiological system that regulates blood pressure, such as Benicar, can cause injury and death to the developing fetus.
The label says the risks are greater during the second and third trimesters. The risks include reduction of fetal renal function and increase in fetal and neonatal death.
The potential for a deficiency in amniotic fluid can result in fetal lung underdevelopment and skeletal deformations.
Benicar comes in tablet form in three different prescription strengths: 5 milligrams (yellow/round pill), 20 milligrams (white/round pill), 40 milligrams (white/oval). This drug can be taken with or without food, and it can also be administered with a diuretic and/or other antihypertensive medications.
It is possible for Benicar to cause adverse reactions when taken concurrently with certain drugs (both prescription and nonprescription). These adverse reactions may include unfavorable side effects and/or lessened effectiveness of Benicar or the other drugs.
Twenty-two patients in a study to determine the link between olmesartan and unexplained sprue-like enteropathy were seen at the Mayo Clinic between August 2008 and August 2011. Olmesartan is an active ingredient in Benicar.
To be included in the study, patients had to first have chronic diarrhea (lasting more than four weeks) while taking olmesartan. Second, the cause of the enteropathy could not be explained by another disorder, such as celiac disease; and finally, discontinuing the drug had to result in clinical improvement.
In 2012, Mayo Clinic researchers published a case series of sprue-like enteropathy associated with patients’ use of olmesartan.
In May 2013, an article was published describing patients with villous atrophy and negative blood tests for celiac disease.
Olmesartan-induced enteropathy was further investigated and confirmed by Mini-Sentinel and CMS Medicare assessments, which showed that at a two-year minimum exposure to the ARB class of drugs, patients using olmesartan had a higher rate of subsequent celiac disease diagnoses than users of other ARBs.
Although olmesartan-containing drugs such as Benicar had been on the market for over a decade, the FDA did not issue its safety announcement about the potential for occurrences of sprue-like enteropathy until 2013. This decision came following its evaluation of FAERS, the Mayo Clinic case series and information from the CMS database. The FDA also ordered the drug manufacturer to change its labeling on the blood pressure medication to include a warning about this.
In premarketing clinical trials, the incidence of adverse effects reported by Daiichi Sankyo related to olmesartan was similar to those of placebo, and the only negative effect linked directly to olmesartan with greater frequency than the placebo, as reported in the prescribing information, was dizziness. While millions of individuals have been prescribed olmesartan over the last several years, reports of severe gastrointestinal reactions associated with its use are claimed to not have surfaced until later in 2012.
Less than a year after the FDA ordered the label change for Benicar and other drugs containing olmesartan, patients who had suffered sprue-like enteropathy began filing Benicar lawsuits. Daiichi Sankyo, Benicar’s manufacturer, agreed in August 2017 to settle Benicar claims from about 2,300 plaintiffs in cases for $300 million.
In 2006, the U.S. Department of Health & Human Services (DOH) submitted a warning letter to Sankyo Pharma Inc. through its Division of Drug Marketing, Advertising and Communications (DDMAC). The letter requested that Sankyo immediately cease its promotion of certain sales and marketing materials that contained unsubstantiated effectiveness and superiority claims, and omitted or minimalized information on the risks associated with the use of Benicar.
In addition to the marketing warnings, Daiichi Sankyo faced kickback allegations. The U.S. Justice Department accused Daiichi Sankyo of paying doctors to prescribe Benicar. Daiichi Sankyo paid $39 million to settle the criminal case.
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