Mutual Matters

FDA Drug Safety Communication Regarding Viberzi (eluxadoline)

Posted by Carrie Lowe, JD on Mar 30, 2017 12:30:00 PM

MMIC_Blue_Pills_Meds-3.jpgOn March 15, 2017, the FDA issued a drug safety warning that Viberzi (eluxadoline), a drug used to treat irritable bowel syndrome with diarrhea (IBS-D), should not be used in patients who do not have a gallbladder. The FDA found that when used in patients without a gallbladder there is an increased risk of developing serious pancreatitis that could result in hospitalization or death.  Patients who are taking Viberzi (eluxadoline) who do not have a gallbladder should stop taking the drug immediately and contact their physician.

What you should do:

  • Inform all clinical staff of the FDA Alert
  • Identify all patients who have been prescribed Viberzi who do not have a gallbladder
  • Contact each patient by telephone; inquire about symptoms of pancreatitis; advise patient to discontinue drug; recommend alternative treatment plan
  • Schedule follow-up appointments with any patient who may need further evaluation/consultation
  • Follow-up with written correspondence to all patients, even those you have spoken to by telephone (see sample letter below)
  • Document all correspondence/treatment recommendations in the medical record
  • Post a notice in your office, on your practice website and any social media sites you maintain (see sample notice below)
  • Report any adverse events related to Viberzi to the FDA MedWatch and to the MagMutual Claims Department (800) 282-4882)

For a sample letter you can share with any patients who may have been prescribed Viberzi, click below.

Find out more

Subscribe to Email Updates

What other resources would you like us to provide?

Sharing Insight on Mutual Matters

As one of the leading mutual providers of Medical Professional Liability insurance, we're here to help all healthcare professionals with the challenges they face on a daily basis. The topics we cover include: 

  • Healthcare legislation updates
  • Patient safety guidance
  • Practice and hospital management advice
  • and more. 

Recent Posts