Post-marketing safety concerns with palbociclib: a disproportionality analysis of the FDA adverse event reporting system.

OBJECTIVES: To explore the association between palbociclib and related adverse events (AEs) in the real world through U.S. Food and Drug Administration Adverse Event Reporting System (FAERS) database.

METHODS: The signal strength of palbociclib-related AEs was done by disproportionality analysis. Clinical priority of palbociclib-related AEs was scored and ranked by assessing five different features. Serious and non-serious cases were compared by Mann-Whitney U test or Chisquared (χ2 ) test. Time to onset and dose-numbers of AEs/Reports were also counted. Gender and age were analyzed by stratified analysis.

RESULTS: There were 61,821 'primary suspected (PS)' reports of palbociclib and 195,616 AEs associated with palbociclib. The four algorithms simultaneously detected 18 positive signals at the SOC level, and 65 positive signals at the PT level. Among the PTs found with positive signals that were not reported in the package insert and also tended to cause serious outcomes included bone marrow failure, neuropathy peripheral, pleural effusion, myelosuppression, pulmonary edema, and pulmonary thrombosis, in addition to hematologic toxicity-associated PTs. Gender (female vs male, χ2  = 5.287, p  = 0.022) and age showed significant differences in serious and non-serious reports. Palbociclib-related 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.

CONCLUSIONS: The study identified potential Palbociclib-related AEs and offered warnings for special 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.