WASHINGTON -- Patients who have undergone cholecystectomy should not receive the irritable bowel syndrome (IBS) drug eluxadoline (Viberzi) because of the potential for severe pancreatitis, the .
"An FDA review found these patients have an increased risk of developing serious pancreatitis that could result in hospitalization or death," the agency said.
IBS patients may be treated instead with over-the-counter agents or prescription drugs, with the particulars depending on whether the condition is marked predominantly by constipation or diarrhea. Eluxadoline is approved for diarrhea-predominant IBS.
The drug was initially approved in May 2015. Since then, the FDA said, the agency has received 120 reports of serious pancreatitis or death in patients receiving eluxadoline. In 76 cases, patients were hospitalized and two of these died. Sphincter of Oddi spasm was noted in six cases.
Among the 68 cases in which patients' gallbladder status was known, 55 occurred in patients whose gallbladders had been removed, including the two fatal cases. Most of the patients in these cases had not exceeded the drug's recommended dosage. There was no indication in the reports that alcohol abuse was a factor.
Also, of the 84 cases for which the duration of eluxadoline treatment was reported, onset of pancreatitis or death occurred after one or two doses in 48.
The FDA recommended that physicians consider alternatives before prescribing eluxadoline to any patient. Besides previous cholecystectomy, other contraindications include history of pancreatic or liver problems, chronic or severe constipation, and heavy alcohol use.