According to a lawsuit filed in federal court, the makers of Benicar were negligent when they failed to warn doctors and patients about its side effects. The consequences may be fatal for some people who took this weight loss drug earlier than it was approved by the FDA. If you or your loved ones are having any issues with this medication, contact an attorney today for legal representation.
High blood pressure is treated with Benicar (olmesartan medoxomil) and its sister medicines Azor and Tribenzor. They may, however, induce serious gastrointestinal damage, such as sprue-like enteropathy, a rare illness.
Thousands of cases were filed against Daiichi Sankyo for Benicar-related ailments, including severe gastrointestinal issues.
In 2013, the FDA issued a warning regarding the relationship between olmesartan products and digestive issues, 11 years after Benicar was initially authorized. Despite accumulating evidence and multiple adverse event reports, drugmaker Daiichi Sankyo never voluntarily issued a warning regarding the drug’s link to intestinal damage.
Daiichi Sankyo did, however, spend $1 billion on false Benicar advertising, according to the FDA. The Benicar drug family has been prescribed tens of millions of times, earning its manufacturer billions of dollars.
More than 2,000 people have filed lawsuits against Daiichi Sankyo demanding financial compensation for injury-related losses after having intestinal problems while using Benicar and its sibling medications.
To address these cases, Daiichi Sankyo negotiated a $300 million settlement on August 1, 2017.
Benicar’s story
Olmesartan medoxomil, a kind of antihypertensive medication known as an angiotensin II receptor blocker, is found in Benicar and its sister medicines (ARB). These medications decrease blood pressure and minimize the risk of cardiovascular events linked with high blood pressure, such as strokes and heart attacks.
Olmesartan medoxomil is not found in all ARBs. Candesartan (Atacand), irbesarten (Avapro), and valsartan are examples of ARBs (Diovan). Other ARB medicines have not been shown to have the intestinal adverse effects associated with the Benicar class of pharmaceuticals.
Benicar (olmesartan medoxomil/hydrochlorothiazide) was approved by the FDA in 2002, followed by Benicar HCT (olmesartan medoxomil/hydrochlorothiazide) in 2003, Azor (olmesartan medoxomil/amlodipine) in 2007, and Tribenzor (olmesartan medoxomil/amlodipine/hydrochlorothia
What Are ARB Drugs and How Do They Work?
Hypertension, or high blood pressure, is treated using ARB medications. The force of blood pushing against the walls of blood vessels is measured by blood pressure. The heart needs to work harder to pump blood when blood pressure is high, and blood vessel walls get overstretched and damaged. High blood pressure may have a variety of severe health consequences over time, including irreversible damage to the heart, brain, blood vessels, and kidneys, as well as heart attacks, blood clots, strokes, and heart failure.
Angiotensin II, a naturally occurring molecule in the blood that causes blood vessels to constrict, is a crucial component in blood pressure. When blood arteries constrict, there is less room for blood to flow, and blood pressure rises.
Angiotensin-converting enzyme inhibitors (ARBs) like Benicar block angiotensin II, enabling blood vessels to relax and broaden, making it easier for blood to flow through and lowering blood pressure.
Enteropathy and Benicar
Blood pressure drugs containing olmesartan seem to harm the stomach, causing a disease known as sprue-like enteropathy. Olmesartan related enteropathy is another name for the illness (OAE).
Enteropathy is a medical word for intestinal illness, while sprue is a condition that causes issues with nutrition absorption in the intestines.
Celiac disease is a well-known kind of enteropathy characterized by hypersensitivity to gluten, a protein present in cereals. When gluten is consumed by celiac disease patients, the body develops an immunological reaction that destroys the villi (villi are small fingerlike projections in the small intestine that absorb nutrients). Digestive disorders come from damage to the villi.
Some folks on olmesartan drugs seem to experience something similar. In fact, celiac disease is often misdiagnosed as olmesartan linked enteropathy.
When the 22 patients stopped using olmesartan, their enteropathy symptoms disappeared.
Patients at the Mayo Clinic in Minnesota were the first to be diagnosed with olmesartan linked enteropathy. Celiac disease was first suspected as the reason of 22 individuals’ diarrhea and enteropathy, but when a gluten-free diet failed to alleviate their symptoms, celiac disease was ruled out. When the 22 individuals stopped using olmesartan, their symptoms disappeared.
Most of the patients in the Mayo Clinic research experienced villous atrophy (damage to the villi) and mucosal inflammation, according to stomach biopsies (inflammation of the mucous membrane layer of the stomach). The results of the Mayo Clinic have been validated by several additional research and case reports.
The following are signs and symptoms of sprue-like enteropathy:
- Diarrhea that is severe and persistent
- Significant weight reduction
- Inflammation and discomfort in the abdomen
- Bloating
- Nausea
- Vomiting
- Malnutrition
- Dehydration
- Fatigue
Sprue-like enteropathy symptoms might appear months or even years after taking olmesartan, and they often need hospitalization.
The Food and Drug Administration has issued a warning about Benicar and enteropathy.
The FDA issued a medication safety communication less than a year after the Mayo Clinic raised awareness of the relationship between olmesartan products and sprue-like enteropathy, stating that Benicar and comparable treatments needed revised labels to warn about the risk.
Previously, the Benicar family of medications’ prescription material indicated diarrhea as a potential side effect, but did not mention any additional gastrointestinal side effects. Enteropathy seems to be connected solely with olmesartan products, according to the FDA, and not with ARB medicines in general.
Patients who filed Benicar cases stated that there was adequate scientific evidence relating olmesartan and enteropathy prior to the FDA’s labeling regulation to support voluntary labeling revisions. They further claimed Daiichi Sankyo’s inability to do so demonstrated a lack of adequate patient care.
Additional research backs up the link between Benicar and Enteropathy.
One Mayo Clinic expert remarked in 2012, around the time when clinical data connected Benicar to intestinal side effects, that the early results might be “the tip of the iceberg.” Many more investigations, like the ones below, indicate a causal link between olmesartan products and intestinal damage, proving that he was correct:
- “This case demonstrated the significance of maintaining a high index of suspicion for olmesartan as a precipitant of spruelike enteropathy in clinicians.” Spruelike Enteropathy Associated with Olmesartan: An Unusual Case of Severe Diarrhea, E. Dreifuss, Y. Tomizawa, N.J. Farber, et al. February 2013, Case Reports in Gastrointestinal Medicine.
- “Villous atrophy related with olmesartan treatment was discovered in patients first classed as unclassified.” – A Diagnostic and Therapeutic Dilemma for Villous Atrophy and Negative Celiac Serology May 2013, J. Gastroenterol.
- “We present a definite example of villous blunting of the duodenum and gastrointestinal symptoms akin to celiac disease induced by an angiotensin II inhibitor [olmesartan].” – M. Lewin, A. Nielsen, A. Steephen Collagenous sprue caused by an angiotensin-II inhibitor (olmesartan) that resolved once the medicine was stopped. World Journal of Gastroenterology, October 2013.
- “The evidence for a link between olmesartan and sprue-like symptoms is accumulating.” M.L. Sanford and A.K. Nagel, respectively. A Review of the Evidence for Olmesartan Medoxomil Mimicking Celiac Disease Symptoms. March 2014, Pharm. Prac.
This collection of case studies and reports is really the “tip of the iceberg.” Around 20 clinical findings linking the Benicar family of medications to intestinal disorders were cited in the main complaint for the Benicar multidistict lawsuit.
Benicar Promotion That Isn’t Legal
Due to illegal marketing of olmesartan goods, physicians prescribed the medications to more patients than they would have otherwise.
Daiichi Sankyo has been in hot water twice, first with the FDA and then with the Justice Department, for illegally selling olmesartan drugs. According to Benicar cases, Daiichi Sankyo’s unlawful advertising of its olmesartan medicines encouraged physicians to give the medications to more patients than they would have otherwise, resulting in increased adverse events in the patient population.
FDA Issues Warnings
Daiichi Sankyo spent $1 billion advertising Benicar and Benicar HCT between 2002 and 2008, helping it become one of the top-selling ARB medications in the United States. The main message of this advertising effort, which included handing out marketing materials to doctors and patients, was that Benicar and Benicar HCT were better, more effective, and safer than other blood pressure medications on the market.
The FDA sent a warning letter to Daiichi in 2006, stating that these statements were baseless and deceptive due to a lack of proof. Benicar advertising materials also omitted and understated the drug’s hazards, according to the FDA.
Daiichi Sankyo was asked to take remedial action, however despite doing so, the FDA issued a similar warning letter in 2013, this time for Daiichi’s unsupported effectiveness claims concerning Benicar.
Violations of the False Claims Act
Daiichi Sankyo agreed to pay $39 million to resolve a False Claims Act whistleblower complaint filed by a former Daiichi sales person, according to the US Department of Justice.
According to the settlement, Daiichi Sankyo paid bribes to doctors in the form of “luxurious entertainment and exaggerated speaker program compensation” in order to get them to prescribe Azor, Benicar, Tribenzor, and other medications.
Lawsuits against Benicar result in a $300 million settlement.
Daiichi Sankyo and 2,300 plaintiffs who brought claims over Benicar and related medications achieved a $300 million settlement on August 1, 2017. Since January 2014, this fund has been used to pay any claims brought against the drugmaker. Attorney fees and the Claims Administrator will each get a share of this amount.
“We think a settlement is in the best interests of everybody, and will enable us to continue our focus on bringing to market breakthrough medicines that help people live healthy and fulfilling lives,” said Glenn Gormley, Daiichi Sankyo’s Executive Chairman and President.
Frequently Asked Questions
Was Benicar lawsuit settled?
A: The Benicar lawsuit is still ongoing.
Can you sue for medication side effects?
A: I cant sue anybody.
Why was Benicar taken off the market?
A: Benicar was taken off the market on April 23, 2014 due to side effects that included pulmonary hypertension and left ventricular dysfunction.