Post-marketing safety concerns with palbociclib: a disproportionality analysis of the FDA adverse event reporting system.
Expert Opin Drug Saf
; 23(5): 637-648, 2024 May.
Article
em En
| MEDLINE
| ID: mdl-38564277
ABSTRACT
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. Outcome analysis, time to onset analysis, dose-report /AEs number analysis, and stratification analysis were all performed.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. Bone marrow failure, neuropathy, peripheral, pleural effusion, myelosuppression, pulmonary edema, and pulmonary thrombosis were also found to have positive signals. 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).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.Palavras-chave
Texto completo:
1
Coleções:
01-internacional
Base de dados:
MEDLINE
Assunto principal:
Piperazinas
/
Vigilância de Produtos Comercializados
/
Piridinas
/
United States Food and Drug Administration
/
Bases de Dados Factuais
/
Sistemas de Notificação de Reações Adversas a Medicamentos
/
Antineoplásicos
Limite:
Adult
/
Aged
/
Aged80
/
Female
/
Humans
/
Male
/
Middle aged
País/Região como assunto:
America do norte
Idioma:
En
Revista:
Expert Opin Drug Saf
Ano de publicação:
2024
Tipo de documento:
Article