Benicar (Olmesartan Medoxomil)
Benicar is a brand of the antihypertensive drug olmesartan medoxomil, and is used to treat high blood pressure and decrease the risk of heart attack or stroke. Manufactured and marketed by Daiichi Sankyo, Inc., Benicar is the subject of thousands of lawsuits due to its propensity to cause severe – and even deadly – gastrointestinal problems. Olmesartan, the active ingredient in Benicar, is sometimes combined with hydrochlorothiazide and/or amlodipine and sold under different brand names, including Benicar HCT, Azor, and Tribenzor.
How Benicar Works
The active ingredient in Benicar is olmesartan medoxomil. Known as a “prodrug,” the medication is absorbed and converted by the body into olmesartan, which stops blood vessels from constricting and thereby reduces blood pressure (a process known as vasodilation). Specifically, olmesartan blocks the creation of angiotensin II, a naturally occurring chemical in the human body that causes the muscular walls of blood vessels to constrict, making the flow of blood cells more difficult and raising blood pressure. By blocking angiotensin II, the drug relaxes and widens blood vessels, helping to increase blood flow around the body.
Uses, Dosage & FDA Approval
The use of olmesartan medoxomil was originally approved by the FDA on April 25, 2002, to treat hypertension – also known as high blood pressure. Since high blood pressure can exacerbate or cause a number of other conditions, including stroke, heart disease, loss of vision, and even kidney disease (renal failure), the ability to manage blood pressure using a safe drug is important for many people. Benicar is often prescribed as part of a comprehensive approach to managing various related medical conditions.
According to the FDA label, approval of the drug was based on positive results from a number of controlled medical trials. The FDA has approved Benicar for use by both adults and children to control hypertension, although the dosage requirements are different for children (6 to 16 years old) than for adults. Benicar is not approved for any other uses than to treat hypertension.
Benicar Drug Details
BRAND NAME Benicar, Benicar HCT, Azor, Tribenzor
GENERIC NAME olmesartan medoxomil
TREATS/PREVENTS Hypertension (high blood pressure)
MANUFACTURER Daiichi Sankyo
COMMON DOSAGES 5 mg, 20 mg, 40 mg
FDA HISTORY First approved in 2002; label updated in 2013
Olmesartan is sometimes combined with other antihypertensive agents to treat high blood pressure and related conditions. When that happens, it may be marketed under other brand names, including:
- Benicar HCT (olmesartan medoxomil with hydrochlorothiazide)
- Azor (olmesartan with amlodipine)
- Tribenzor (olmesartan with amlodipine and hydrochlorothiazide).
Benicar Side Effects and Safety Concerns
Many patients have experienced moderate to severe side effects while taking Benicar. The most common side effects include dizziness and nausea, although in extreme cases patients have experienced kidney failure, gastrointestinal injuries, and even death.
Benicar poses serious risks to pregnant women, fetuses, and newborn children, and can be fatal, giving rise to several lawsuits. It should not be taken while pregnant, or given to children under the age of one.
Common Benicar Side Effects
The most common side effect of Benicar is dizziness, with around 3% of adults on the drug experiencing this at some point. Other, less severe side effects of Benicar include:
Common Benicar Side Effects
If you are concerned about any of these side effects, speak to your doctor.
Severe Benicar Side Effects
When taking any drug, it is important to understand the risks and know which symptoms to watch out for. Speak to your doctor before taking Benicar, and seek medical help if you experience any of the following severe side effects while using the drug:
- Blood in urine
- Low blood pressure (which may result in dizziness, nausea, fatigue, and blurred vision)
- Chest Pain
- Tachycardia (fast heartbeat)
- Symptoms of renal failure (including swelling, fatigue, and shortness of breath)
Certain side effects may indicate a severe allergic reaction to the drug, which can be life threatening. These include hives, tightness in the chest, trouble breathing, and swelling in the mouth, tongue, or face. If you experience any of these side effects while taking Benicar, seek immediate medical attention. Before taking the drug, tell your doctor if you have any drug allergies that may result in an allergic reaction.
Other serious conditions can result from taking Benicar, and the impact of these can be lifelong. Below is a summary of potential complications patients may experience, and the symptoms to watch out for.
Benicar and Kidney Problems
While Benicar is used to treat high blood pressure to prevent other serious conditions such as kidney failure from developing, some patients have experienced kidney problems as a result of taking the drug. Swelling in the feet, hands, or ankles are common indicators of kidney problems. Other signs include rapid weight gain (typically as a result of fluid retention) and puffiness in the face. You may also feel unexpectedly cold, unusually tired, and/or experience a sudden loss in appetite.
Kidney problems often lead to other serious conditions and can be fatal. Make an appointment with your doctor immediately if you experience any symptoms of kidney problems while using Benicar.
Benicar and Sprue-like Enteropathy
A study conducted by the Mayo Clinic in 2012 revealed that Benicar is associated with a gastrointestinal disease called sprue-like enteropathy. As a result, the FDA approved changes to the label of Benicar in 2013 to reflect this severe side effect. Many patients require hospitalization after developing this condition.
The most common and severe symptoms of sprue-like enteropathy are chronic diarrhea, abdominal pain, and extreme weight loss. Patients participating in the Mayo Clinic study experienced chronic diarrhea lasting more than a year and an average individual weight loss of 40 lbs. Some participants also experienced villous atrophy, a degradation of the lining of the small intestine affecting the body’s ability to digest and absorb nutrients. In some cases, symptoms of malnourishment were noted. Malnourishment can lead to numerous long-term health problems including slower recovery after injury or disease, decreased mobility due to muscle wastage, and death.
Sprue-like enteropathy can also cause dehydration, bloating, nausea, and fatigue. It can develop slowly, with patients often experiencing symptoms months or even years after first taking Benicar. Sprue-like enteropathy may be mistaken for like celiac’s disease, but since it is medically induced, it is not affected by a gluten-free diet. Due to the similar symptoms, misdiagnoses have occurred in the past, so users of Benicar should alert their doctor immediately that they are taking the drug when seeking medical assistance.
The FDA recommends that patients who develop sprue-like enteropathy as a result of the drug should stop taking Benicar at once.
Benicar and Fetal Toxicity
The active ingredient in Benicar can cause fetal kidney failure, sometimes resulting in fetal death. Studies have shown that taking medicines to regulate blood pressure or the sodium concentration in the blood stream can have harmful and even fatal effects on a fetus.
For this reason, Benicar carries a black box warning against using the drug while pregnant or to treat infants under the age of one. The FDA uses black box warnings to indicate serious or potentially life-threatening side effects that a drug may cause. If you are currently or suspect that you may be pregnant, stop taking Benicar and speak with your doctor about how to manage your high blood pressure.
Injuries and Deaths
In 2010, the FDA conducted a study to determine whether Benicar increases the risk of heart-related deaths, based on the results of two clinical trials. In both trials, diabetic patients who took Benicar had a higher rate of cardiac-related deaths than those who took a placebo. At the end of the review, which took more than four years to accomplish, the FDA said there was “no clear evidence” that Benicar increased the risk of heart-related deaths.
Because patients have experienced so many serious side effects, up to and including death, a number of Benicar lawsuit claims have been brought against Daiichi Sankyo, Inc. (or one or more of its subsidiaries). One figure has put the number of legal actions filed in federal court at over 1,900, and that number is likely to grow as more individuals press a legal claim. In general, the complaints focus on the most serious side effects of olmesartan, although other less serious problems and adverse effects are also mentioned.
The first Benicar cases began in 2017. The consolidated Benicar case In Re: Benicar Products Liability Litigation, 14-MD-2606 has settled for $300 million.