On 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.