Benicar (olmesartan medoxomil) was approved by the Food and Drug Administration in 2002 to treat high blood pressure (hypertension). It is a member of the “angiotensin receptor blockers” (ARB) class of anti-hypertensive medications.
Benicar is manufactured and marketed in the US by the Daiichi Sankyo, the second-largest pharmaceutical company in Japan. Daiichi Sankyo sells pharmaceutical, medical, and agricultural products in 50 countries and reports about $12 billion in annual revenue. Between 2010 and 2013, Benicar was selling at a yearly rate of about 11 million U.S. prescriptions and brought $3 billion per year in global revenue.
The active ingredient in Benicar (olmesartan) is also one ingredient in combination high-blood pressure medications such as Benicar HCT (olmesartan with hydrochlorothiazide, a diuretic), Azor (olmesartan with amlodipine, a calcium channel blocker), and Tribenzor (olmesartan with hydrochlorothiazide and amlodipine).
Unlike other members of the ARB class of blood pressure medications, Benicar has been shown to cause a serious gastrointestinal side effect known as “sprue-like enteropathy” which can cause severe, chronic diarrhea and significant weight loss and is similar to symptoms of celiac disease. Multiple lawsuits have been filed against Daiichi Sankyo for serious injury caused by Benicar and more are expected to follow.
What is Benicar?
Benicar is an inhibitor of the angiotensin-II receptor, also known as an angiotensin receptor blocker (ARB) or a “sartan” because of the generic name olmesartan. The ARB class of anti-hypertensives work by blocking the activity of angiotensin-II in the cardiovascular system.
Angiotensin-II is a product of the liver which is intended to regulate the blood pressure system. When the protein is produced by the liver, it has a vasoconstrictive effect that tightens the blood vessels and raises blood pressure. Increased blood pressure makes the heart work harder to pump blood through the body and can also damage other organs such as the kidneys. Blocking angiotensin-II helps to lower the blood pressure by stopping vasoconstriction. This helps the blood flow more freely through the vessels and decreases the work the heart must do to supply the body with blood and oxygen.
Benicar FDA Warnings
Benicar was shown to cause severe gastrointestinal illness in some patients who took the medication in a research connection discovered by the Mayo Clinic in 2012. The Mayo Clinic notified the FDA about a high occurrence of “sprue-like enteropathy” that had symptoms similar to Celiac disease with side effects such as severe and chronic diarrhea, lack of nutrient absorption and extreme weight loss.
All of the observed patients had tested negative for Celiac disease, but all had taken Benicar. Most patients who were identified as Benicar related illnesses improved after discontinuing the medication, but some did not. The rate of non-Celiac or unclassified sprue occurrence may be as high as 30 percent. Following the Mayo Clinic’s report, the FDA added a warning to prescribing information of Benicar in July of 2013.
Benicar also has a black-box warning regarding the risk of birth defects in women who are pregnant while taking the medication. Benicar and other related medications containing olmesartan are the only member of the ARB class of medications that have caused the GI side effects, many patients have sued the manufacturer, Daiichi Sankyo for injuries, hospitalization and permanent damage caused by Benicar.
Benicar Side Effects
Benicar and medications containing olmesartan have a number of side effects. Like most medications, many of these side effects are mild to moderate but may have a negative impact on the patient’s quality of life. In other cases, however side effects are more severe and may be life-threatening.
Common side effects of Benicar include:
- Hair loss
- Nausea and vomiting
- Irregular heartbeat
- Chest pain
- Angioedema (swelling of the skin)
- Liver and kidney impairment
If side effects worsen or become bothersome, they may indicate a more serious medical problem and should be reported to a physician.
Benicar Severe GI Side Effects
Benicar may also cause a much more severe adverse event affecting the gastrointestinal system in a condition known as “sprue-like enteropathy”. In July of 2013, the FDA began requiring a warning about the gastrointestinal side effects of Benicar or sprue-like enteropathy.
Sprue-like enteropathy causes severe symptoms that are similar to Celiac disease, but the patient does not have and will test negative for Celiac disease. Dietary changes normally recommended for Celiac patients will not help those with Benicar-related gastrointestinal illness.
GI symptoms caused by Benicar include:
- Severe abdominal pain
- Severe and chronic diarrhea
- Nutrient malabsorption
- Significant weight loss
Doctors will often test for Celiac disease when a patient reports these symptoms. Unfortunately, in some cases even if Benicar is discontinued, the patient will continue to suffer from the gastrointestinal illness, and they will not respond to traditional Celiac regimens.
Some patients have suffered with the illness for multiple years, seen multiple physicians and may have been hospitalized for the illness. In addition, some patients may have permanent injury to the gastrointestinal system with a condition known as “villous atrophy” which results in a permanent lack of ability of the GI system to absorb nutrients.
Some cases of villous atrophy may be so severe that the small intestine allows larger undigested food particles to pass into the blood stream. These particles can cause a severe immune reaction, resulting in body-wide inflammation and a number of food sensitivities.
Benicar Mayo Clinic Report
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.
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 Legal Trouble
The maker of Benicar has landed in legal trouble multiple times. The company received warnings from the FDA in 2006 and 2013 due to its claims about Benicar and the risks associated with use of the drug. There have also been concerns about Benicar research trials which were run for only three months, when most people require blood pressure medications for much longer. It is believed that had the trials been in line with real use-experience, side effects of the drug might have been more evident prior to the drug’s release.
In addition, some independent reviews of adverse event data showed that Daiichi Sankyo should have been aware of the increased GI complaint rate but Daiichi failed to include this information in marketing material.
Benicar Lawsuit Information
A number of patients who were injured after taking Benicar sued the manufacturer, Daiichi Sankyo Inc. Some patients were required to undergo years of medical treatments with extreme pain and physical debility caused by their drug injuries including gastrointestinal complaints and other health conditions such as nutrient malabsorption and weight loss.
Some patients required hospitalization to treat drug injury complications and may have been left with permanent injury or disability such as the failure of the digestive system or need for a permanent feeding tube
Daiichi Sankyo is reported to have spent approximately $1 billion in aggressive promotions claiming Benicar was superior to other ARBs with an increased safety and efficacy profile which was not proven. Daiichi Sankyo was twice warned by the FDA for making false or misleading claims about the medication indicating that claims were unsubstantiated, and risks were not included in marketing materials.
Multiple lawsuits were filed against Daiichi Sankyo for aggressive promotion, deceptive advertising, and failure to warn the medical community and patients about the increased risk of side effects and permanent injury. In 2017, Daiichi Sankyo and co-marketer Forest Laboratories announced they would be spending up to $300 million to settle lawsuit claims against Benicar, Benicar HCT, Azor and Tribenzor for sprue-like enteropathy and other severe GI complaints. This settlement agreement was reported to cover at least 2,300 cases already filed and a number that may have been expected.
Notwithstanding claims relating to this product, the drug/medical device remains approved by the U.S. FDA.
- Daiichi spends $300M to settle Benicar suits, Biopharma Dive (08/2017)
- Update 2-FDA looking into death risk from Daiichi’s Benicar, Reuters (06/2011)
- Top 100 Drugs of 2013, Drugs.com (2014)
- Benicar Prescribing Information, RxList (2020)
- FDA Drug Safety Communication: FDA approves label changes to include intestinal problems (sprue-like enteropathy) linked to blood pressure medicine olmesartan medoxomil, U.S. Food and Drug Administration (07/2013)
- Severe Spruelike Enteropathy Associated With Olmesartan, Mayo Clinic Proceedings (06/2012)
- Think Like a Doctor: Stomach Bug Solved!, NY Times Well Blog (02/2014)