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The FDA has issued a safety announcement warning that Viberzi should not be used in patients who do not have a gallbladder due to an increased risk for serious pancreatitis.

Hospitalizations and deaths due to pancreatitis have been reported with the use of this drug in such patients, with symptom onset occurring with just one or two 75 mg doses in patients who do not consume alcohol, according to the announcement.

Viberzi (eluxadoline, Allergan) is an orally administered mixed mu-opioid agonist and delta-opioid antagonist that was approved for diarrhea-predominant irritable bowel syndrome in May 2015. The FDA said it is working with the manufacturer to address this safety concern.

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