Benicar (Olmesartan Medoxomil)
Benicar is a brand of the antihypertensive drug olmesartan, and is used to treat high blood pressure and decrease the risk of heart attack or stroke. Manufactured and marketed by Daiichi Sankyo, 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
Side Effects and Safety Concerns
According to the FDA, one of the most common Benicar side effects is dizziness. While other side effects have been reported – including back pain, bronchitis, diarrhea, headaches, coughing, and others – they had about the same level of incidence as placebos in the controlled trials. One of the biggest safety concerns with Benicar is a gastrointestinal condition known as sprue-like enteropathy. This terrible condition causes an extremely severe form of diarrhea, similar to celiac disease. Benicar-induced enteropathy can also cause substantial weight loss in a short period of time, as well as abdominal pain, anemia, bloating, vomiting, nausea, and fatigue.
Injuries and Deaths
In 2010 the FDA conducted a study to determine whether there was a link between Benicar and heart-related deaths in diabetic patients. At the end of the test, the FDA concluded that there was no clear evidence of a link. Despite these findings, you should speak to your doctor if you experience chest pain, irregular or fast heartbeat, or other side effects relating to the heart while taking Benicar. Benicar should not be taken by pregnant women, infants, or individuals taking diuretics, due to the potential for severe adverse effects and risk of death.
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).
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 are expected to be tried in 2017. The cases are overseen by U.S. District Judge Robert Kugler.