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).
Benicar Side Effects and Safety Concerns
According to the FDA, the most common side effect during Benicar trials was 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.
Benicar and Enteropathy
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. In fact, some individuals have been incorrectly diagnosed with celiac disease when in reality it was Benicar causing their gastrointestinal problems.
Benicar-induced enteropathy can cause patients to experience a substantial amount of weight loss in a short period of time, as well as abdominal pain, anemia, bloating, vomiting, nausea, and fatigue. According to at least one study, patients who experienced enteropathy due to Benicar lost an average of 40 lbs, with at least one patient losing as much as 125 lbs. Such extreme weight loss, as well as the loss of electrolytes and nutrients necessary to stay alive, can lead to permanent medical problems or even death.
Many patients may feel safe when taking Benicar because they don’t experience these symptoms right away. However, case reports have shown that it can take months or even years for enteropathy to manifest after a patient begins taking Benicar.
Because of the dangers of enteropathy, the FDA required a new warning on Benicar and other olmesartan product labels, warning consumers of safety issues related to taking this drug. The updated label, added on July 3, 2013, instructs patients to discontinue use of the drug if they experience symptoms of sprue-like enteropathy.
Other Severe Effects
In addition to sprue-like enteropathy, Benicar can cause a number of other problems in people who take it.
Pregnant Women: Benicar can be extremely dangerous for fetuses. Due to the nature of how the drug works, it can cause fetal kidney failure, resulting in deformation or death of the fetus. Anyone who is pregnant or at risk of being pregnant should not take Benicar.
Infants: The FDA strictly prohibits children younger than one year old from being given Benicar, even to treat hypertension. Just as Benicar can damage fetus kidneys, it can affect the development of the kidneys in very young children, since the organs are still maturing.
Individuals Taking Diuretics: Patients who are taking high doses of diuretics can be at risk for hypotension (extremely low blood pressure) if they also take Benicar, due to the depletion of salt or fluid volume in the body. Usually, this condition can be treated with the administration of intravenous saline; however, if not properly treated, it could become a dangerous situation.
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 olmesartan 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.
In May 2012, the Mayo Clinic discovered a link between Benicar and sprue-like enteropathy, symptoms of which include excessive diarrhea, dehydration, vomiting, and weight loss. In extreme cases, these severe symptoms could lead to permanent disability and possibly even death. Additional studies confirmed the findings later in 2012, and in 2013 the FDA required Daiichi Sankyo to add a new warning to Benicar label.
Approved Uses of Benicar
|Brand Names||Benicar, Benicar HCT, Azor, Tribenzor|
|Generic Name||olmesartan medoxomil|
|Treats||Hypertension (high blood pressure)|
|Common Dosages||5 mg, 20 mg, 40 mg|
|FDA Approval||First approved in 2002; label updated in 2013|
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.
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 taking Benicar have experienced so many serious side effects, up to and including death, a number of lawsuits have been filed 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 1,700, and that number is likely to grow as more individuals press a legal claim.
This is not the first time Daiichi Sanyko has been in legal trouble over Benicar. In 2015, the biopharmaceutical company paid a $40 million to the U.S. Department of Justice. This sum settled an allegation by the government agency that Daiichi Sankyo had made illegal payments to doctors in return for prescribing Benicar and other drugs to their patients from 2005 through 2011.
When such a high number of lawsuits are brought before the federal court system, they are often consolidated using a method known as multidistrict litigation (MDL). While each case is still considered an individual case, the common features of the collective lawsuits are tried in a similar fashion under one or a handful of justices. This allows the cases to be tried consistently, using the same level of evidence and scrutiny.
Lawsuits related to Benicar and other olmesartan drug products created by Daiichi Sankyo have been consolidated into an MDL case in the United States District Court for the District of New Jersey. The MDL number for Benicar lawsuits is MDL 2606.
According to the Master Long Form Complaint, the injuries suffered by plaintiffs in MDL 2606 cases include:
The primary complaint by these plaintiffs is that Daiichi Sankyo either knew or should have known about these possible injuries, and that they failed to customers of these potential dangers.
The first cases under MDL 2606 are expected to be tried in 2017. The cases are overseen by U.S. District Judge Robert Kugler.