FDA Warns of Increased Risk of Serious Pancreatitis with Allergan’s Viberzi

Regulatory NewsRegulatory News | 15 March 2017 |  By 

Following the death of two patients without a gallbladder on Allergan’s irritable bowel drug Viberzi (eluxadoline), the US Food and Drug Administration (FDA) on Wednesday warned about the increased risk of serious pancreatitis in such patients.

Viberzi is approved by FDA for use in adults for the treatment of irritable bowel syndrome with diarrhea.

From May 2015, when Viberzi was first approved, through February 2017, FDA says it received 120 reports of serious cases of pancreatitis or death.

Among the 68 patients who reported their gallbladder status, 56 of them did not have a gallbladder and received the currently recommended dosage of Viberzi, the agency said. Seventy-six patients were hospitalized and two patients died, both of whom did not have a gallbladder.

“One death was associated with pancreatitis and one death was associated with sphincter of Oddi spasm. The case of death from pancreatitis was characterized by acute, severe abdominal pain, nausea, and vomiting within 60 minutes of taking a single dose of Viberzi. The case of death associated with sphincter of Oddi spasm reported severe abdominal pain and vomiting shortly after taking the first dose of Viberzi. Both patients were hospitalized for treatment. Notably, the patient who experienced pancreatitis died within 3 days of taking the initial Viberzi dose,” FDA said.

“Health care professionals should not prescribe Viberzi in patients who do not have a gallbladder and should consider alternative treatment options in these patients. Hospitalizations and deaths due to pancreatitis have been reported with Viberzi use in patients who do not have a gallbladder,” FDA said. “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.”

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