Adverse reactions associated with the off-label use of octreotide for pancreatitis ： A pharmacovigilance study based on FDA adverse event reporting system

Abstract

Abstract Purpose: Octreotide is often off label used for the treatment of pancreatitis because of its effect of inhibiting pancreatic secretion of trypsin. However, the adverse effects (AEs) associated with octreotide for pancreatitis treatment have not been adequately studied. Methods: Adverse events data of Octreotide from the FDA Adverse Event Reporting System (FAERS) database during the first quarter of 2004 to the third quarter of 2023 was collected. Disproportionality analysis was performed using the reporting odds ratio (ROR) and the proportional reporting ratio (PRR) method. The time-to‐onset analysis was conducted using the Weibull shape parameter (WSP) test. Cumulative incidences were plotted using the Kaplan‐Meier method, and log‐rank test was used to compare the cumulative incidences. Results: A total of 23,047 records from the FAERS database were included in this study, including 92 records for patients with pancreatitis and 22,955 records for other indications. A total of 42 AEs signals were detected in pancreatitis patients, distributed among 15 SOCs. 27 of these signals were detected as positive signals only in patients with pancreatitis, but not in other indications. The cumulative incidence of adverse reactions did not differ between the pancreatitis and other indication populations (log-rank test, P = 0.665). In the WSP test for octreotide associated AEs, the upper limit of 95% CI of the shape parameter were less than 1 for both populations, suggesting an early failure type profile. Conclusion: The adverse reaction profile of octreotide off label used for the treatment of pancreatitis is significantly different from that of other diseases.