The blood pressure medication Benicar (olmesartan medoxomil), along with its sister drugs Benicar HCT, Azor, and Tribenzor, have been linked to serious gastrointestinal injury, prompting thousands of lawsuits to be filed against drug maker Daiichi Sankyo
Benicar is linked to severe gastrointestinal injuries, including sprue-like enteropathy.
Benicar is an angiotensin II receptor blocker (ARB) FDA-approved to lower blood pressure associated with hypertension. By blocking angiotensin receptors, which can cause blood vessels to constrict, Benicar keeps blood vessels dilated and helps treat high blood pressure. But the drug is also linked to severe gastrointestinal injuries, including the rare disorder sprue-like enteropathy.
ClassAction.com is speaking to patients who developed gastrointestinal side effects while taking Benicar and helping them to take action against drugmaker Daiichi Sankyo. Find out whether you have a case during a free consultation.
Serious Benicar Adverse Side Effects
Benicar may cause the gastrointestinal (GI) condition sprue-like enteropathy, which produces symptoms similar to those of celiac disease. It may also cause lymphocytic colitis, microscopic colitis, and collagenous colitis.
Patients experiencing Benicar side effects may suffer from the following:
- Chronic diarrhea
- Severe diarrhea
- Abdominal pain
- Significant weight loss
- Kidney failure
- Other stomach problems
Onset of these symptoms may occur months to years after a Benicar regimen begins.
Studies Linking Benicar to Gastrointestinal Problems
The link between Benicar and sprue-like enteropathy was first observed at the Mayo Clinic in 2012. Researchers there studied 22 patients taking olmesartan and suffering from chronic diarrhea and median weight loss of 40 pounds. Fourteen of the patients required hospitalization. The original diagnosis was celiac disease, but blood tests did not confirm this diagnosis. When patients stopped taking olmesartan they recovered and gained back an average of 27 pounds.
All patients in the FDA review with severe diarrhea and weight loss showed improvement after discontinuing olmesartan.
Later in 2012, dozens of similar cases were observed at Mayo Clinic and other centers, prompting one researcher to speculate that the findings represented “the tip of the iceberg.”
The following year, FDA conducted its own review of 23 serious Benicar adverse event reports involving patients with severe diarrhea and weight loss. Similar to the Mayo Clinic study, all patients in the FDA review showed improvement after discontinuing olmesartan.
Another 2013 study, published in the American Journal of Gastroenterology, found damage to intestinal villi (tiny structures that aid digestion) with olmesartan use.
Lawsuit filings show approximately 20 studies and case reports linking olmesartan products to gastrointestinal problems.
FDA Warnings About Benicar
In response to its review of Benicar-related intestinal problems, the FDA issued a Drug Safety Communication saying that it had approved label changes for olmesartan to warn about the drug’s link to sprue-like enteropathy. FDA recommended in the communication that Benicar patients who develop enteropathy symptoms discontinue the drug and begin treatment with a different blood pressure medication.
Importantly, FDA notes that other ARB drugs have not been associated with sprue-like enteropathy.
Daiichi Sankyo Benicar Kickback Scheme
Daiichi Sankyo agreed in 2015 to a $39 million settlement with the U.S. federal government and state Medicaid programs related to allegations that the manufacturer paid kickbacks to physicians who agreed to prescribe its drugs, including Benicar, Azor, and Tribenzor.
The blood pressure drug olmesartan medoxomil is marketed under the following brand names, all made by Daiichi Sankyo:
- Benicar HCT
Benicar Mass Tort Lawsuit
In March 2015, a group of federal judges ordered that Benicar lawsuits filed in different states be consolidated into a single multidistrict litigation (MDL, or mass tort) in New Jersey. More than 1,500 claims are consolidated in the MDL, and the number of Benicar lawsuits is only expected to increase.
A mass tort is similar to a class action in that it groups together many similar lawsuits for streamlined processing. But unlike a class action, a mass tort allows each lawsuit to be handled individually. This means that MDL plaintiffs have their own lawsuit and, for patients who are seriously injured, it may also mean that they have a better chance of receiving a fair financial recovery.
The first Benicar MDL cases are expected to be tried in 2017.
Benicar lawsuits allege that drugmaker Daiichi Sankyo of:
- Bringing to market products that cause serious gastrointestinal injuries
- Inadequately warning about the risk of gastrointestinal injury from Benicar, Benicar HCT, Azor, and Tribenzor
- Misrepresenting the safety of olmesartan products, despite knowing (or having sufficient reason to know) that Benicar and similar drugs are unsafe when used as directed and for their intended purpose
- Designing defective, unsafe, and inherently dangerous pharmaceutical products
- Not sufficiently testing Benicar and similar drugs
- Failing in its duty to create safe products
- Creating products that cause harm which far outweighs their benefit
- Valuing profits over the safety and wellbeing of patients
- Causing patient harm and financial losses as a result of these acts and omissions
Examples of Benicar Lawsuits
Here’s what some actual plaintiffs are saying about Benicar in lawsuits against Daiichi Sankyo
- A Benicar lawsuit filed in Ohio claims that, after the plaintiff began taking Benicar, she developed manifestations of intestinal and/or colonic disease, including chronic diarrhea, rapid weight loss, nausea and vomiting, malnutrition, weakness, dehydration, and kidney failure. The patient was hospitalized on numerous occasions for her symptoms and required extensive medical testing and treatment that resulted in a significant financial burden as well as pain and suffering, according to the lawsuit.
- A lawsuit filed in California alleges that the plaintiff was prescribed and took Benicar HCT, which caused her to develop chronic diarrhea, severe weight loss, nausea, vomiting, malnutrition, and dehydration. She was admitted to the hospital for extended periods due to these symptoms. Since a link between Benicar and gastrointestinal problems was not known at the time, plaintiff claims, she underwent extensive and costly treatment that did not provide any relief. Following an FDA notice warning about Benicar and sprue-like enteropathy, plaintiff discontinued Benicar HCT and her symptoms resolved, she says.
- In a jointly filed Benicar lawsuit, two men claim that using the antihypertensive drug caused them to develop severe intestinal problems such as sprue-like enteropathy, colitis, and intestinal malabsorption, leading to chronic diarrhea, rapid weight loss, nausea and vomiting, malnutrition, and renal failure. The patients say that they were hospitalized and underwent monitoring, screening, and testing associated with their intestinal problems and that they suffered financial losses as well as pain and suffering as a result of their Benicar use.
You may be eligible for a Benicar lawsuit if you:
- Took Benicar, Benicar HCT, Azor, or Tribenzor
- Developed serious gastrointestinal injuries
- Suffered losses (i.e. financial losses, physical and emotional pain and suffering, loss of quality of life, etc.) as a result of Benicar-related injuries
Those who believe a loved one’s death was caused by Benicar or a similar drug may also be eligible for a lawsuit.
What to Do if You Are Affected
ClassAction.com is speaking with patients who experienced excessive weight loss, chronic diarrhea, vomiting, and other gastrointestinal side effects while taking Benicar and/or its sister drugs.
Only an attorney can determine whether you are eligible to file a lawsuit against Daiichi Sankyo. If you have reason to believe Benicar caused your injuries, you can receive a free case review from ClassAction.com.