Pharmaceutical Litigation


Pharmaceutical Litigation

after taking

If you suffered potentially
life-threatening gastrointestinal
problems as a result of taking
Benicar®, our Patient Advocates at
Pharma Suits can help.

Free Case Review

Benicar: How it Works

Benicar is a widely prescribed medication used to lower blood pressure, also known as hypertension.

High blood pressure can damage kidneys and cause a heart attack or stroke. It often has no symptoms and a survey published in the Journal of the American Medical Association (JAMA) showed almost one-third of U.S. adults were unaware they were suffering from hypertension. That is why it’s gained the name as the “silent killer.”

Because of the potentially serious and fatal side effects, identifying and managing hypertension is advised by medical professionals.

Olmesartan is the key ingredient in Benicar. Olmesartan medoxomil was developed by drug maker Sankyo twenty years ago. A generic Benicar is only available outside of the U.S.

The U.S. Food and Drug Administration (FDA) approved Benicar in 2002 for use in this country. The Japanese drug manufacturer Daiichi Sankyo reports it writes more than 11 million prescriptions a year.

Benicar falls within the class of drugs called angiotensin receptor blockers or ARBs. These medications work by blocking angiotensin 2, which is a hormone and natural chemical that regulates blood pressure and is normally found circulating in the blood stream.

Angiotensin 2 is formed by an angiotensin converting enzyme (ACE) which is the chemical that attaches to the receptors found in many tissues and the muscle cells of blood vessels. Most of the damage to the body occurs after angiotensin 2 connects to its receptor.

Angiotensin 2 can cause blood vessels to constrict, it can increase water retention, stimulate blood vessels and stiffen the heart wall. When blood vessels constrict, blood pressure rises putting extra pressure on the vessels. This can harm the body in a number of ways. Besides elevating blood pressure, the heart and kidneys can also be compromised.

ARBs like Benicar interfere and prevent angiotensin 2 from binding to the receptor like a key in a door, which greatly reduces the effects of angiotensin 2.

ARBs are prescribed when angiotensin 2 causes hypertension or harms the heart and kidneys.

Most ARBs are available with other medications such as hydrochlorothiazide (HCTZ) which may make ARBs more effective. HCTZ is a diuretic which also helps to lower blood pressure by relieving the body of excess fluids.

Other drugs containing olmesartan medoxomil include Benicar HCT, Azor and Tribenzor. Some doctors prescribe these combination medications to prevent kidney damage (Cozar and Avapro) or to prevent or minimize harm to a patient with a heart condition.

While the U.S. Food and Drug Administration says side effects are rare and the benefits outweigh the risks, an emerging picture of Benicar use shows it can have a serious impact on the gastrointestinal system.

For some patients, olmesartan drugs can cause chronic diarrhea and abdominal pain. Initially this side effect may be diagnosed as Celiac disease, a disease of the digestive system that caused abdominal bloating, pain and chronic diarrhea. Celiac disease is an autoimmune disorder affecting about one in 100 people. It is thought to have a genetic link.

When patients with Celiac disease eat wheat, rye and barley gluten, their body sparks an immune response which can include symptoms such as diarrhea, constipation, anxiety, depression, among other conditions. Often patients are prescribed a gluten-free diet.

But a number of Benicar users report similar symptoms, often misdiagnosed for years as Celiac disease. Research shows Benicar is associated with sprue-like enteropathy or villous atrophy. Essentially the villi in the intestine are damaged and flattened by use of the drug, reducing its ability to absorb nutrients. The condition of malabsorption can potentially be fatal to users of Benicar and Benicar HTC, Azor and Tribenzor.

The FDA took the adverse event reports seriously enough to suggest a label change to Benicar in April 2014 showing its link to gastrointestinal side effects. The drug now warns patients that they may suffer substantial weight loss and malnutrition as a result of the chronic diarrhea cause by the use of Benicar.

However, it may take years for these changes to become apparent. French researchers found the increased risk develops at about 12 months. By two years the risk factor rises over 950 percent. Unfortunately, Benicar is often prescribed for long periods of time during which a patient can lose weight while seeking some answers for their uncomfortable condition. During that time, the damage may be more difficult to reverse and may become permanent.

That’s why more than 1,000 patients have now filed defective product lawsuits against the Japanese drug maker Daiichi Sankyo. The number of cases is growing and has been consolidated into one court under something called multidistrict litigation (MDL). The plaintiffs contend that Daiichi knew about the problem but covered it up and that they did not properly and fully inform the drug’s end user- the physician- who can then inform the patient with true informed consent.

Benicar also carries a black-box warning that pregnant woman not take the drug because it can be toxic to the developing fetus. If a woman becomes pregnant while on Benicar she will have to stop taking the drug and should tell her doctor immediately.

Need help now? Speak with a
Patient Advocate now:

Who We Are

The pharmaceutical litigation attorneys at Farah & Farah go after negligent corporations that put unsuspecting consumers in harm's way. Pharmaceutical companies not only have a duty to manufacture drugs that are safe, but they also have the obligation to warn consumers regarding dangerous side effects that can be caused by these drugs.

Learn More