You are here

FDA Drug Safety Communication Regarding Viberzi (eluxadoline)

March 29, 2017

On March 15, 2017, the FDA issued a 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)

Sample Letter

Dear Patient:

We are writing to you because you have been prescribed the drug Viberzi (eluxadoline). On March 15, 2017, the FDA issued a warning that Viberzi (eluxadoline) 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. 

We are advising you to stop taking Viberzi immediately and get emergency medical care if you develop new or worsening stomach-area or abdomen pain, or pain in the upper right side of your stomach-area or abdomen that may move to your back or shoulder. This pain may occur with nausea and vomiting. These may be symptoms of pancreatitis. The FDA alert can be found here.

Please contact us at your earliest convenience at (XXX) XXX-XXXX to discuss an alternative treatment plan.

Sincerely,

Physician

Sample Notice for Office or Website

On March 15, 2017, the FDA issued a warning that Viberzi (eluxadoline) 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. 

If you have been prescribed Viberzi, we are advising you to stop taking Viberzi immediately and get emergency medical care if you develop new or worsening stomach or abdominal pain, or pain in the upper right side of your stomach-area or abdomen that may move to your back or shoulder. This pain may occur with nausea and vomiting. These may be symptoms of pancreatitis. Please contact us at your earliest convenience at (XXX) XXX-XXXX to discuss an alternative treatment plan.

The FDA alert can be found here.

Disclaimer

The information and resources provided in this course or publication have been prepared to provide general information only. It is not to be relied upon in lieu of or as a substitute for legal, medical or other professional advice. The laws, rules, regulations and case law may differ in your state. Please consult a licensed attorney in your state for specific questions and advice. While all care has been taken in the preparation of this course or publication, no responsibility is accepted by MagMutual Insurance Company or the MagMutual Patient Safety Institute or its employees or agents for any errors, omissions, or inaccuracies, or for any known or unknown consequences that may result from reliance on any information provided in this publication.

Footnotes