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Postmarketing cases of eluxadoline-associated pancreatitis in patients with or without a gallbladder
L Harinstein1, E Wu1, A Brinker1
1Division of Pharmacovigilance, Office of Surveillance and Epidemiology, FDA Center for Drug Evaluation and Research, Silver Spring, MD, USA.
Background:
Cases of pancreatitis were identified in the eluxadoline clinical development program, reflected in initial product labelling, and the subject of postmarketing reports.
Aim:
To analyse postmarketing cases of eluxadoline-associated pancreatitis.
Methods:
We retrospectively analysed all US adverse event reports of pancreatitis associated with eluxadoline reported to the FDA Adverse Event Reporting System (FAERS) database from May 27, 2015 through February 15, 2017.
Results:
The analysis included 119 cases of pancreatitis associated with eluxadoline; one resulted in death and 75 in hospitalisation. Sixty-seven cases reported the presence (n = 12) or absence (n = 55) of the patient's gallbladder. The eluxadoline dose received in the 55 cases of patients without gallbladders was 75 mg (n = 43), 100 mg (n = 5), or not reported (n = 7). Of the 119 cases, 37 reported the patient did not abuse alcohol and 82 did not report the alcohol abuse status. The single fatal case occurred in a patient without a gallbladder who received eluxadoline 75 mg and did not abuse alcohol. Forty-seven cases reported development of pancreatitis within the first or second dose of eluxadoline initiation. The median time to onset for the development of pancreatitis (n = 83) was 1 day, ranging from 1 to 56 days of continued use of eluxadoline.
Conclusion:
The FAERS cases suggest that patients with or without a gallbladder receiving eluxadoline are at risk for the development of pancreatitis. However, patients without a gallbladder, despite receiving the recommended lower dose of eluxadoline 75 mg and screening for alcohol abuse, appear to be overrepresented among patients who developed eluxadoline-associated pancreatitis.
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