Benicar, the brand name of the medication, olmesartan medoxomil is used to treat high blood pressure. It was approved by the Food Drug Administration in 2002 and is produced by Daiichi Sankyo Inc., the US division of Daiichi Sankyo Company, Limited.
Benicar is a member of the angiotensin receptor blocker (ARB) class of medications and is the second highest selling blood pressure medication in the US. In 2013, Benicar accounted for $3.1 billion or just under 30 percent, of Daiichi Sankyo’s worldwide revenue of about $11 billion with over 11 million prescriptions.
Benicar works by blocking the activity of angiotensin-II. Angiotensin is a potent vasoconstrictor that is produced by the liver and used by the body to regulate blood pressure. If the blood pressure is too high, the heart may become stressed and other organs such as the kidney may be damaged. Blocking the activity of angiotensin-II allows the blood vessels to relax and the blood pressure to lessen.
Olmesartan is also included as an active ingredient in combination blood pressure pills such as Benicar HCT, Azor and Tribenzor. All of the ARB medications have a number of side effects, but Benicar and other medications containing olmesartan may cause a severe adverse reaction involving the gastrointestinal tract which may be permanently disabling.
The FDA issued a warning and required additional labeling on Benicar and other olmesartan products because of the GI side effects. Multiple lawsuits have been filed against Daiichi Sankyo Inc. regarding serious injury caused by Benicar and more lawsuits are expected.
Common Side Effects of Benicar
Like most medications, the ARB class including Benicar has a number of side effects. Most of the side effects are not life threatening or permanently disabling and may decrease in severity after the patient has been taking Benicar for a period of time. In addition, most of the common side effects will go away if the medication is discontinued.
Some common side effects of Benicar:
- Hair loss
- Nausea and vomiting
- Chest pain
- Irregular heart beat
- Angioedema (swelling of the skin)
- Liver impairment
- Kidney impairment
Some of the mild side effects of Benicar may indicate a more serious medical problem and all side effects should be reported to a physician.
Benicar and the Gastrointestinal System
Benicar has been shown to cause a severe effect on the gastrointestinal system. Some patients taking Benicar have experienced symptoms that are similar to Celiac disease, however dietary changes recommended for Celiac patients will not help those with Benicar-related gastrointestinal illness. Sprue-like enteropathy caused by Benicar has symptoms such as:
- Severe and chronic diarrhea
- Severe abdominal pain
- Nutrient malabsorption
- Significant weight loss
Some patients with Benicar-caused gastrointestinal illness may develop villous atrophy. Villous atrophy is a permanent condition which destroys the ability of the small intestine to properly absorb nutrients. In severe cases, villous atrophy may become so severe that the intestines allow undigested food particles to pass through the lining into the bloodstream. These food particles may cause a serious immune response which results in systemic inflammation and a heightened sensitivity to food (new food allergies).
In July of 2013, the FDA began requiring a warning about the gastrointestinal side effects of Benicar.
Benicar Black Box Warning
The top of the prescribing information for Benicar includes a black-box warning. A black-box warning is the most severe warning that a medication can have and is placed inside a box with a thick black border so that it is readily seen by healthcare professionals who prescribe the medication.
Benicar’s black-box warning indicates a high risk of the development of birth defects and the possibility of fetal death in pregnant women who take Benicar. Benicar or other products containing olmesartan should not be taken by women who are pregnant or intend to become pregnant.
Benicar FDA Warning
In 2012, the Mayo Clinic released a report and notified the FDA about the occurrence of “sprue-like enteropathy” in multiple patients. These patients had symptoms that were similar to Celiac disease but tested negative for the disorder. In addition dietary changes normally recommended for Celiac patients, such as eliminating all gluten from the diet, did not resolve the illness. All of the identified patients had been taking Benicar.
After discontinuation of the medication, some of the patients saw improvement in their symptoms but others may have suffered permanent damage. In July of 2013, The FDA required that a warning be added to the prescribing information on Benicar regarding the risk of gastrointestinal effects. Benicar, and other products containing olmesartan, is the only member of the ARB class that has caused this side effect.
Some patients who have been injured by Benicar have sued Daiichi Sankyo Inc. These patients may have been required to consult with multiple physicians in search of relief of their pain and suffering. Some patients have required hospitalization for a period of months and may have suffered permanent injury to the intestines, requiring insertion of a feeding tube.
The manufacturer of Benicar conducted clinical trials for the medication that only lasted 3 months but it is well-known that blood pressure medications are often taken by a patient for a much longer period of time. In most cases, a diagnosis of hypertension requires life-long treatment. The manufacturer did not test the medication long enough to identify time-related adverse events and an independent review of post-marketing information showed that Daiichi Sankyo should have become aware of GI events.
Over $1 billion was reportedly spent by Daiichi Sankyo between 2002 and 2008 to market Benicar. The company claimed in aggressive promotions that Benicar was more effective and safer than other ARB medications. The manufacturer was warned by the FDA for making false and misleading claims about the efficacy and for failure to include some of the risks in promotional materials.
Several lawsuits have already been filed against Benicar’s manufacturer, Daiichi Sankyo in New Jersey, Texas and other states. Attorneys for the plaintiffs claim that the company has placed profits above patient safety by failing to warn about Benicar’s risk and by aggressively promoting the drug with misleading information. Many more Benicar lawsuits are expected.