In July 2013, the U.S. Food and Drug Administration (FDA) issued a warning to patients and doctors that the popular blood pressure medication Benicar had been linked to a severe side effect called sprue-like enteropathy. The side effect, commonly confused with Celiac disease or a sensitivity to gluten, had devastating effects on patients. A week after the FDA’s warning, Dr. Joseph Murray took to YouTube to educate patients about the drug’s risks.
Dr. Murray is a gastroenterologist and a professor of medicine at the Mayo Clinic in Rochester, New York who has seen first hand the side effects of Benicar in patients. In the video, Dr. Murray advises any patients who are taking Benicar and have been diagnosed with Celiac disease to visit with their doctor in light of the new FDA warning.
Many Benicar patients learned the hard way the drug can cause debilitating side effects, but Dr. Murray’s video no doubt helped spread awareness to patients who suffer from sprue-like enteropathy. Many patients feel Benicar’s manufacturer, Daiichi Sankyo, failed to warn consumers of the risks associated with the drug and are now trying to hold the company responsible through legal action. There are more than 1,700 lawsuits currently pending against the company.
Plaintiffs have called into question the validity of the clinical trial leading to Benicar’s approval with the FDA. The management of high blood pressure is a life-long commitment, but the clinical trial testing Benicar’s safety and efficacy only lasted three months. Plaintiffs believe the risk of sprue-like enteropathy was not properly evaluated because the clinical trial was so short.
But plaintiffs are also pointing to Benicar’s massive advertising budget. Between 2002 and 2008, Daiichi Sankyo spent $1 billion on Benicar advertising. Plaintiffs believe Daiichi Sankyo’s heavy advertising of Benicar focused more on the benefits of the drug and downplayed the potential risks.
Plaintiffs have to wait just a little longer for their day in court with Daiichi Sankyo. Benicar trials are scheduled to begin in 2017.