Blog

FDA Warns IBS Drug Viberzi is Associated with an Increased Risk of Pancreatitis For Patients Without a Gallbladder

By Burg Simpson

March 16, 2017   Ohio Dangerous Drugs and Medical Devices, Ohio Legal Updates

On March 15, 2017, FDA issued a Drug Safety Communication, warning that patients without a gallbladder who are prescribed the drug Viberzi (eluxadoline) face an increased risk of serious pancreatitis that could result in hospitalization or death.

Viberzi is a medicine that is used to treat irritable bowel syndrome with diarrhea (IBS-D).  A recent FDA review found that between the date of Viberzi’s approval in May 2015 and February 2017, FDA had received reports of 120 serious cases of pancreatitis, seventy-six of which resulted in hospitalizations and two of which resulted in death.  Further analysis of these reports reflected that many of these Viberzi users did not have a gallbladder.  The review also found that symptoms of pancreatitis associated with Viberzi had been reported with just one or two doses at the recommended dosage in patients that did not have a gallbladder and who did not consume alcohol.

Given these findings, FDA issued this Drug Safety Communication to warn that “[p]atients who do not have a gallbladder should not take Viberzi.”

If you or a loved one suffered injuries that you believe were caused by Viberzi, contact one of the experienced product liability attorneys at Burg Simpson today. Our award-winning lawyers would be happy to discuss your potential claim. Call 1-800-713-9340 or fill out our contact form for a FREE no-obligation consultation today.

Top 100 National Trial Lawyers Legal 500 Best Lawyers in America Super Lawyers US News 2014 Top 25 Most Influential Lawyers