Real-world drug safety study of somatostatin analogs based on the food and drug administration adverse event reporting system database.

BACKGROUND

Somatostatin analogs (SSAs), synthetic peptides mimicking endogenous somatostatin, are widely used to treat neuroendocrine tumors and acromegaly. However, their use is often accompanied by adverse events (AEs) that may compromise patient safety. This study systematically evaluated AE signals associated with SSAs using the FDA Adverse Event Reporting System (FAERS) database to inform clinical practice.

METHODS

Adverse event reports (AERs) related to octreotide, lanreotide, and pasireotide were extracted from FAERS (2004Q1-2024Q1). Patient demographics, including gender, age, and reporting region, were analyzed descriptively. Signal detection methods-Proportional Reporting Ratio (PRR), Reporting Odds Ratio (ROR), Bayesian Confidence Propagation Neural Network (BCPNN), and Empirical Bayes Geometric Mean (EBGM)-were applied to evaluate AE associations.

RESULTS

A total of 28,116 AERs were analyzed, including 18,690 for octreotide, 7468 for lanreotide, and 1958 for pasireotide. Gastrointestinal and hepatobiliary AEs were prominent across all SSAs. Octreotide was strongly linked to necrotizing enterocolitis in neonates, while pasireotide showed significant associations with acute pancreatitis and glucose metabolism disorders. Elevated risks of liver and biliary tract infections were also identified.

CONCLUSION

This study confirms known safety signals and uncovers new AE risks associated with SSAs, emphasizing the need for vigilant pharmacovigilance and guiding clinicians in risk mitigation.