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

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.

KEYWORDS:

• Breast cancer
• data mining
• FAERS
• pharmacovigilance
• palbociclib

Declaration of interests

The authors have no relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending, or royalties.

Reviewer disclosures

One reviewer received a travel grant and an honorary from Pfizer. The remaining reviewers have no other relevant financial relationships or otherwise to disclose.

Data availability statement

The original contributions presented in the study are included in the article/Supplementary Material; further inquiries can be directed to the corresponding author.

Author contribution statement

QC was responsible for the design of the study, data processing and the writing of the article. MHS was responsible for the guidance and design of the project. XS was responsible for the collection of data, and YZZ and SPZ were responsible for the revision of the manuscript.

Supplementary material

Supplemental data for this article can be accessed online at https://doi.org/10.1080/14740338.2024.2338247

Acknowledgments

We would like to thank Dr. Minghui Sun for his guidance and help in this study, and also thank each member of the team for their efforts in data collection and protocol design.

Additional information

Funding

This paper was not funded.