Timeline Of Benicar® Approval And Complications
Hypertension drug Benicar (olmesartan) is a top-selling product for its manufacturer, Daiichi Sankyo. Doctors write more than 10 million prescriptions for Benicar for nearly 2 million patients each year, making it one of the most prescribed drugs in the angiotensin II receptor antagonist class. However, while almost any prescription medication can have side effects, Benicar is the only drug in its class that’s been linked to life-threatening and deadly gastrointestinal injury.
For patients taking Benicar, what seems like a pesky stomach bug can quickly spiral out of control, requiring medical intervention and even hospitalization. It’s not uncommon for Benicar patients to experience side effects such as mild bloating, diarrhea, and abdominal pain. Unfortunately, for some patients, these relatively minor side effects give way to severe, chronic diarrhea, a difficulty absorbing nutrients, and uncontrollable weight loss.
Some Benicar patients develop sprue-like enteropathy, a serious gastrointestinal condition caused by damage to the intestinal lining. Because sprue-like enteropathy shares symptoms with other gastrointestinal disorders, such as Celiac disease, it’s often misdiagnosed, which can subject patients to treatments they don’t need for illnesses they don’t have. Meanwhile, the undiagnosed sprue-like enteropathy continues.
Fortunately, for most patients, these horrific Benicar side effects and complications are only temporary, stopping once the patients discontinue the drug. However, the fact that serious Benicar side effects aren’t usually permanent doesn’t make up for what affected patient experienced.
Whether you were just prescribed Benicar to lower your blood pressure or have experienced dangerous its gastrointestinal side effects and complications, here’s what you need to know.
Benicar Approval and Complications
Benicar has been on the market since 2002, and in the years since its approval, has racked up a concerning number of patient complaints and adverse event reports. Consider the following timeline:
- 2002: Daiichi Sankyo applies for and receives approval for Benicar from the U.S. Food and Drug Administration (FDA). The FDA approved the drug following a small-population, three-month clinical trial.
- 2003: The FDA also approves Benicar HCT, which is a combination of Benicar and the diuretic hydrochlorothiazide.
- 2006: The FDA sends Benicar’s manufacturer a warning letter regarding the company’s misleading statements and unsubstantiated claims in Benicar marketing and advertising.
- 2010: The FDA issues a warning that Benicar may increase the risk of death in diabetic patients.
- 2012: Researchers publish a report in the Mayo Clinic Proceedings medical journal that discusses the development of sprue-like enteropathy in some Benicar patients.
- 2013: The American Journal of Gastroenterology publishes a report on patients who develop villous atrophy (damage to the cells that line the intestinal wall) while taking Benicar.
- 2013: The FDA issues a drug safety communication warning doctors and patients about the gastrointestinal risks associated with Benicar use. According to this communication, serious Benicar side effects can develop months or even years after the beginning of treatment.
- 2013: The FDA once again warns Daiichi Sankyo against making misleading efficacy and safety claims for Benicar.
- 2014: A large French study, as well as studies published in the medical journals Alimentary Pharmacology and Therapeutics and the Journal of Clinical Pathology support the link between Benicar and sprue-like enteropathy found in previous studies.
Benicar patients who suffered serious gastrointestinal complications while taking it began filing lawsuits against Daiichi Sankyo in 2014, claiming the company continued to market and sell the drug long after realizing the risks associated with its use. As of June 2017, Daiichi Sankyo faces approximately 2,000 lawsuits brought by former Benicar patients.
Did You Suffer Serious Complications While Taking Benicar?
The gastrointestinal side effects associated with Benicar use can be debilitating, life-threatening and, in the most extreme cases, deadly. If you were hospitalized due to Benicar-related complications like severe, chronic diarrhea, significant weight loss or sprue-like enteropathy, you may be eligible to seek compensation from Daiichi Sankyo.
Contact McGartland Law today to schedule a free initial consultation to discuss the details of your potential Benicar case.