Brief

FDA warns of Viberzi pancreatitis risk

Dive Brief:

  • The Food and Drug Administration has issued a warning of an increased risk of serious pancreatitis linked with Allergan's irritable bowel with diarrhea drug (IBS-D) Viberzi (eluxadoline) in patients without a gallbladder.
  • Between approval of the drug in May 2015 and February 2017, the FDA received 120 reports of cases of pancreatitis. About 56 patients did not have a gallbladder and were taking Viberzi—two of those patients died. 
  • Allergan and the FDA are working together to address the concerns; in the meantime, the FDA has warned physicians not to prescribe Viberzi to patients without a gallbladder.  

Dive Insight:

"Hospitalizations and deaths due to pancreatitis have been reported with Viberzi use in patients who do not have a gallbladder. Symptoms of pancreatitis have occurred with just one or two doses of Viberzi at the recommended dosage for patients who do not have a gallbladder (75 mg) and who do not consume alcohol," said the FDA in a statement.

The drug was approved as Truberzi in Europe in September 2016, where it is under additional monitoring, but the European Medicines Agency has not commented on pancreatitis.

Viberzi's sales were $38 million in the fourth quarter of 2016, and $93.3 million over 2016. Between May 2015 and July 2016, around 34,000 people in the US were dispensed Viberzi from outpatient retail pharmacies.

Alternative treatments for patients without a bladder recommended by the FDA include lifestyle and diet changes, or treatment with Lotronex (alosetron hydrochloride) or Xifaxan (rifaximin). Physicians are also encouraged to report any adverse events to the FDA MedWatch program.

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Filed Under: Regulatory / Compliance
Top image credit: Wikimedia user Flinga