What Is Olmesartan, The Active Ingredient In Benicar?
Olmesartan is a chemical branded for sale in the United States under several brand names:
- Benicar HCT
All of these medications are manufactured and marketed by Daiichi Sankyo. While each drug contains different chemicals, they are all based on olmesartan medoxomil, a chemical that relaxes overly-tight blood vessels to reduce blood pressure. Olmesartan belongs to a class of chemicals known as angiotensin receptor blockers, because they block the action of a hormone, angiotensin, that causes blood vessels to constrict.
Benicar was first approved by the US Food & Drug Administration in 2002. The drug is indicated for the treatment of hypertension, both alone and in combination with other drugs classified as antihypertensives. Almost immediately after being released, Benicar became a blockbuster, generating billions of dollars in revenue for Daiichi Sankyo. Around a decade would pass before medical researchers began to express concerns about the medication’s safety.
Potential Side Effects Of Benicar
In 2012, a study of Benicar-related side effects found evidence that drugs based on olmesartan medoxomil could cause a strange mix of intestinal issues called sprue-like enteropathy. Sprue is another name for celiac disease, a chronic autoimmune disorder that affects the small intestine:
- Severe and chronic diarrhea
- Weight loss
- Loss of appetite
- Abdominal pain and bloating
- Nausea and vomiting
Researchers generally believe that celiac disease is caused by genetic mutations and passed from parents to their children. A very similar disorder, however, appears to be linked to certain pharmaceutical drugs. This condition is called sprue-like enteropathy. One of those drugs is olmesartan medoxomil.
Over the following years, more and more research would discover that people who take Benicar, but have no genetic predisposition for celiac disease, seem more likely to develop celiac-like symptoms. More troubling, their symptoms do not respond to gluten-free diets, the most effective treatment for celiac. Instead, the celiac-like symptoms only go away after the patients stop taking an olmesartan-containing drug.
FDA: Stronger Warning Labels
The evidence was damning. Eventually, the US Food & Drug Administration stepped in, telling Daiichi Sankyo to create new warning labels for its olmesartan-based products. Approved in 2013, the new labeling contained explicit references to the chemical’s link to sprue-like enteropathy, including an instruction to healthcare professionals: “consider discontinuation of Benicar in cases where no other etiology [cause] is found.” The label’s Warnings and Precautions section had even more to say:
“Severe, chronic diarrhea with substantial weight loss has been reported in patients taking olmesartan months to years after drug initiation […] If a patient develops these symptoms during treating with olmesartan, exclude other etiologies. Consider discontinuation of Benicar in cases where no other etiology is identified.”
The warning makes a critical point about this alleged risk. Note that the symptoms of sprue-like enteropathy can, and often do, only begin to appear months or years after a patient has begun taking Benicar (or other olmesartan medications). This delay, in part, explains why researchers only became aware of Benicar’s link to celiac-like symptoms a decade after the drug was approved.
Likewise, the public, along with the legal community, only learned of this link after the Food & Drug Administration announced its seminal decision to strengthen the drug’s warning label.
Olmesartan Lawsuits Consolidated In New Jersey
Legal action soon followed. The first Benicar lawsuit was filed in 2014, Reuters reports. Soon after, dozens of other patients had followed in those footsteps, pursuing their own claims over alleged Benicar complications. In 2015, a panel of federal judges decided that the litigation should be consolidated and made more efficient. As a result, the lawsuits were transferred to the US District Court of New Jersey, where they were soon joined by hundreds of other claims.
In New Jersey, the lawsuits were guided through pre-trial motions and discovery (evidence-gathering) by Magistrate Judge Joel Schneider and District Judge Robert Kugler. Eventually, the litigation came to include about 2,300 personal injury and wrongful death claims.
Settlement Agreement Would Resolve Litigation
Now, Daiichi Sankyo has agreed to settle these legal claims by establishing a $300 million trust fund. In the coming weeks, people who have viable claims over Benicar-related side effects will begin to submit their applications and medical records to the Olmesartan Products Resolution Program.
After being reviewed by a claim administration company, each valid claim will be paid out according to a 6-level injury schedule, ranging from confirmed diagnoses of sprue-like enteropathy to associated gastrointestinal symptoms.
Importantly, the fund is open both to claimants who have already filed lawsuits and to people who have yet to bring their claims in court. It’s open to injured patients and families who have lost loved ones to intestinal disorders associated with olmesartan. The deadline, however, is fast approaching. Patients and families who have yet to file a lawsuit have until August 23, 2017 to retain legal counsel and file the application documents necessary with the trust fund’s Administrator.