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Blood Pressure Medication Benicar Linked to Rare, Severe Gastrointestinal Illness

David W. Hodges
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Partner at Kennedy Hodges LLP practicing pharmacy error, medical malpractice and personal injury law

Hypertension (high blood pressure) is a major health concern in the United States. The Centers for Disease Control and Prevention (CDC) states that 1 in 3 Americans suffers from hypertension. Over the past decade, many of those people turned to the prescription drug Benicar to help control their high blood pressure and the dangers that accompany this condition. It is estimated that more than 11 million people were prescribed Benicar this year. However, concerns have been raised over the drug’s safety, and researchers from the Mayo Clinic say they found a link between Benicar and serious gastrointestinal problems.

What Is Benicar?

Benicar is a medication that helps lower blood pressure. Hypertension results when the force of the blood pushing against the arteries is too great, raising blood pressure. This can lead to heart disease and stroke—two of the leading causes of death in the U.S. High blood pressure is particularly dangerous as it has no signs or symptoms. Patients learn of their hypertension only through monitoring by a health professional. The CDC dubbed hypertension “the silent killer.”

Benicar (also known as olmesartan) works by blocking the release of angiotensin II, a protein produced by the liver that causes blood vessels to constrict. Blocking this protein keeps the blood vessels open and helps blood to flow more easily, reducing the pressure on the blood vessels and the stress on the heart pumping oxygen. Other common angiotensin II receptor blockers (ARBs) include Cozaar, Atacand, Teveten, and Avapro.

Introduced by Japanese drug maker Daiichi Sankyo, Benicar was approved by the U.S. Food and Drug Administration (FDA) in 2002.

Studies Show Link to Intestinal Problems

Benicar has been used by millions of people over the past 10 years. But in 2012, researchers from the Mayo Clinic published a case series stating a link between the drug and serious gastrointestinal problems. An FDA investigation followed, with findings that supported the Mayo Clinic conclusions. In 2013, the FDA published a warning that Benicar use could result in a condition called sprue-like enteropathy—a rare disorder that causes malabsorption of nutrients, rapid weight loss, severe and chronic diarrhea, and stomach pain. After the FDA warning, changes were made to the drug’s label to cite the risks.

Sprue-like enteropathy mimics symptoms of celiac disease, a gluten intolerance, which can make it difficult to diagnose. Researchers found that patients using Benicar did not respond to a gluten-free diet, the typical answer to celiac disease. However, when patients discontinued their use of Benicar, the symptoms resolved. None of the other ARBs on the market have been shown to cause this type of gastrointestinal issue. Patients have reported developing these problems months to years after starting Benicar.

Legal Troubles Plague Daiichi Sankyo

Many patients endured pain, underwent hospitalization, and accumulated debt because of sprue-like enteropathy they believe was brought on by Benicar. In February 2014, some of those who experienced these symptoms while taking the drug filed lawsuits against the manufacturer.

One of the first people to take action was George Williams, who spent over 100 days in the hospital and suffered continuing health problems while taking Benicar. Williams’ lawsuit claims Daiichi Sankyo manufactured a dangerous drug. He and others allege that the company:

  • did not properly test Benicar before selling the drug
  • knowingly designed a defective product
  • misrepresented the effectiveness of Benicar in advertising materials
  • failed to warn consumers about possible dangerous side effects

As of September, over 1,000 lawsuits had been filed against the maker of Benicar. Like other similar cases, the suits have been combined in multidistrict litigation. This means one federal judge will preside over all the cases, although each case will receive its own independent verdict.

Additionally, Daiichi Sankyo has had other legal troubles. The company settled a $39 million lawsuit with the federal government earlier this year for violating the False Claims Act.The company reportedly paid physicians kickbacks to prescribe the company’s drugs, including Benicar. The company noted the payments were part of a “speaker program,” but investigators said the physicians often spoke only to their own office employees, duplicated topics at the same dinner, and were treated to lavish dinners totaling more than the law allows.

Decisions for the Benicar lawsuits will be made on a case-by-case basis, although multidistrict litigation typically starts with a small number of “bellwether” trials. These first few cases give both sides an idea of what the outcome may be. Parties can then decide to drop the lawsuits, settle, or proceed through the judicial system. The first cases are expected to begin in the fall of 2016.

If you or someone you love suffered similar gastrointestinal problems while taking Benicar, you may be entitled to compensation. Contact us at 888-526-7616 to request a free, no obligation case evaluation.