Benicar Lawsuit Guideline

Dozens of plaintiffs filed Benicar lawsuits seeking compensation for alleged damages sustained due to the terrible sprue-like diarrhea weight loss. Benicar injuries are not limited to just gastrointestinal issues, however. Other than the numerous additional side effects that make this medication stand out among the other sartans, the FDA issued a black label to warn about its danger. The “black box warning” is the most ominous admonition issued by FDA, and in this case, exhorts patients to show the highest degree of caution using this drug during pregnancy. Due to the high risk of fetal toxicity, pregnant women should immediately stop taking this medication as it can “cause injury of death to the developing fetus.”

What Is Benicar

Benicar (Olmesartan medoximil) is an angiotensin receptor blocker (ARB) used to reduce high blood pressure in patients with hypertension (1). ARBs, also known as “sartans”, are a group of molecules used to control blood pressure in patients who are intolerant to conventional ACE-inhibitor therapy. Just like the other sartans, olmesartan acts by blocking angiotensin II AT1 receptors. These receptors are responsible for a vasoconstricting effect, and thus, when blocked, relax vessels reducing blood pressure (2).

Side Effects – Diarrhea and Sprue-like Enteropathy

Diarrhea is included among the various Benicar side effects together with other adverse reactions such as dizziness, vomiting or rash that are common for all ARBs. However, diarrhea, as well as the other gastrointestinal problems caused by this medication seem to be much more severe than its similar counterparts.

This form of unexplained chronic diarrhea and enteropathy significantly affects a patient’s health, up to the point of preventing the intestine from properly absorb nutrients from digested food. Long-term consequences of these intestinal problems do, in fact, include substantial weight loss (usually around 20 kilograms) and malnutrition (4, 5, 6).This type of unique diarrhea is somewhat similar to the symptoms showed by people affected by Celiac Disease (CD). Probably the most significative symptoms are villous atrophy and mucosal inflammation, two conditions that greatly reduce the ability of the small intestine to absorb adequate amounts of nutrients.

However, Celiac Disease is also characterized by a specific immune response such as positive antibody testing and symptomatic response to a gluten-free diet. Benicar enteropathy is not affected by any dietary restrictions, nor it does present any immunological or histological findings except for a typical subepithelial collagen deposition called “sprue” (5). As shown in a first clinical study submitted by the Mayo Clinic in 2012, the only improvement was seen when patients stopped taking the drug (6).

FDA Warnings and risks

In April 2014, the FDA approved a change to the drug’s label to include a warning about the risk of concerning intestinal problems (4). Similarly, even the Agenzia Italiana del Farmaco (AIFA), the Italian agency equivalent of the FDA, issued an analogous warning about a danger for potential gastrointestinal risks associated with the use of this medication (8).

Daiichi Sankyo Fradulent Behaviors

It won’t be the first time that Daiichi Sankyo is under the FDA’s radar for fraudulent or misleading behaviors, however. Daiichi Sankyo was already warned twice by FDA for producing misleading advertisement about their products. They received their first warning in 2007 because they failed to inform the public about the potential dangers and contraindications of their drug Evoxac (cevimeline hydrochloride). In the warning letter from the Department of Health and Human Services, the regulators accuse the pharmaceutical company in clear terms:

“These promotional materials are false or misleading because they present efficacy claims for Evoxac but fail to communicate information about the risks associated with its use.” (15)

After just a couple of years, in 2013 Daiichi Sankyo received another warning letter from the FDA, claiming they repeated a similarly fraudulent advertisement campaign for their infamous diabetes medication:

“The promotional material is misleading because it makes unsubstantiated efficacy claims associated with Benicar and Benicar HCT. […] Promotional materials are misleading if they represent or suggest that a drug is more effective than has been demonstrated by substantial evidence or substantial clinical experience. ” (16)

This last letter is especially alarming, as Daiichi Sankyo is known for a terrible past that permanently stained its reputation: the Ranbaxy issue. In 2014, the newly acquired generic drugmaker company acquired by Daiichi was found guilty of felony charges caused by lack of manufacturing safety by the U.S. Department of Justice. The FDA issued a recall of over 500,000 bottles of Lipitor (atorvastatin), forcing the company to pay $500 million in fines to settle down the civil and criminal allegations. In April 2015, Daiichi Sankyo agreed to pay $39 million to settle down a whistleblower lawsuit that alleged the pharmaceutical company paid kickbacks to doctors and physicians to convince them prescribing various medications, including Benicar (17, 18, 19).

Article written by: Dr. Claudio Butticè, Pharm.D.

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