Scientific Reports (Mar 2025)
Disproportionality analysis of post-marketing safety concerns associated with selumetinib in the FDA adverse event reporting system
Abstract
Abstract The FDA has granted approval for the use of selumetinib in the treatment of pediatric patients who are at least 2 years old and have neurofibromatosis type 1 (NF1) with symptomatic, inoperable plexiform neurofibromas (PN). Nevertheless, the safety of selumetinib over an extended period of time in sizable cohorts remains uncertain. The objective of the present study was to assess the adverse events (AEs) associated with selumetinib by analyzing data from the US food and drug administration adverse event reporting system (FAERS). The FAERS database was retrospectively queried to extract reports associated with selumetinib from the third quarter of 2020 to the first quarter of 2024. To identify and evaluate potential AEs in patients receiving selumetinib, various disproportionality analyses such as the reporting odds ratio (ROR), the proportional reporting ratio (PRR), the Bayesian confidence propagation neural network (BCPNN), and the multi-item gamma Poisson shrinker (MGPS) were employed. A total of 546 reports of selumetinib as the “primary suspected (PS)” and 1437 cases of selumetinib-induced AEs were identified. 42 AE signals were detected at the preferred term (PT) level after complying with four algorithms simultaneously. Commonly significant signals for cardiotoxicity, ocular toxicity, skin toxicity, and increased creatine phosphokinase have been observed. Additionally, previously reported AE signals such as proteinuria were detected. Most AEs related to selumetinib occur within the first month after the initiation of therapy. Our study improves the comprehension of selumetinib’s safety profile by offering a thorough analysis of the adverse events (AEs) recorded post-marketing. These findings highlight the necessity of ongoing surveillance to detect and assess any adverse events linked to selumetinib.
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