Post-Marketing Safety Concerns With Palbociclib A Disproportionality Analysis of the FDA Adverse Event

Abstract

Purpose: By using U.S. Food and Drug Administration Adverse Event Reporting System (FAERS) database, the adverse reactions (ADRs) of palbociclib were mined through disproportionality analysis, so as to provide reference for rational use of palbociclib. Methods: Data mining of palbociclib-associated adverse events (AEs) was done by reporting odds ratio (ROR), proportional reporting odds ratio (PRR), Bayesian confidence propagation neural network (BCPNN), and multi-item gamma Poisson shrinkage (MGPS) algorithms. Findings: At the SOC level, the four algorithms simultaneously detected 18 positive signals, and at the PT level, the four algorithms simultaneously detected 65 positive signals. The PTs that lead to severe outcome are mainly associated with pulmonary toxicity, hematological toxicity and myelosuppression. Palbociclib-associated AEs had a median onset time of 79 days (interquartile range [IQR] 20-264 days), with the majority occurring within the first 1, 2, 3 months, and one year of treatment. Implications: The study identified potential palbociclib side effects and offered warnings for high-risk AEs, providing further data for palbociclib safety studies in breast cancer patients. Nonetheless, prospective clinical trials are needed to validate these results and explain their relationship.