Benicar

Benicar (olmesartan) is an angiotensin receptor blocker (ARB) antihypertensive medication used to treat high blood pressure. It may cause a serious gastrointestinal side effect known as sprue-like enteropathy which is similar to celiac disease.

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 was developed by Sankyo Co., a Japanese pharmaceutical company in 1995 who merged with Daiichi Pharmaceuticals in 2005 to become the second largest pharmaceutical manufacturer in Japan, Daiichi Sankyo Company, Limited. Benicar is manufactured and marketed in the US by the subsidiary Daiichi Sankyo Inc. (DSI). Daiichi Sankyo sells pharmaceutical, medical, and agricultural products in 50 countries and reported $11 billion in total worldwide revenue in 2013. Benicar is among the top 100 selling drugs in the US and is sold at a rate of 11 million prescriptions bringing $3.1 billion in worldwide revenue for Daiichi. 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 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:

  • Rash
  • Hair loss
  • Arthritis
  • Nausea and vomiting
  • Irregular heart beat
  • Chest pain
  • Angioedema (swelling of the skin)
  • Liver and kidney impairment

Benicar Severe Side Effect

Benicar may also cause a much more severe adverse event affecting the gastrointestinal system. Benicar has been shown to cause sprue-like enteropathy in some patients. 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. 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 also has a black-box warning (the most severe warning a medication can have) regarding the possibility of birth defects in women who take the medication while they are pregnant. Pregnant women should not take Benicar or products containing olmesartan due to injury of death of the developing fetus.

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
  • Rash
  • Nausea and vomiting
  • Arthritis
  • 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.

Benicar Lawsuits

Benicar InfographicA number of patients who were injured by taking Benicar have sued the manufacturer, Daiichi Sankyo Inc. Some patients have undergone years of treatment with extreme pain and physical debility. They may have been required to visit multiple physicians to seek relief from intestinal complaints and may have required treatment for other health conditions caused by the side effects of the medication such as nutrient malabsorption and weight loss. Some patients have also been hospitalized to treat complications and have had permanent injury or disability such as the failure of the digestive system, requiring a permanent feeding tube. Benicar clinical trials were only performed for 3 months, even though most anti-hypertensives are prescribed for much longer than 6 months and may be given for years. In addition, independent reviews of adverse event data has shown that Daiichi Sankyo should have been aware of the increased GI complaint rate; however Daiichi failed to include this information in marketing material. 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. The manufacturers of Benicar, Daiichi Sankyo have been warned twice 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 have been 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. The company has been accused of placing profits above patient safety and many more Benicar lawsuits are expected. Patients who have been injured by Benicar or other medications containing olmesartan may be eligible for actual damages (medical costs, permanent injury) and punitive damages (to punish the company). Notwithstanding claims relating to this product, the drug/medical device remains approved by the U.S. FDA. 

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