Newly identified adverse events for gemcitabine using the Food and Drug Administration Adverse Event Reporting System

ABSTRACT

Background

Our research aimed to identify previously undocumented adverse events (AEs) in the gemcitabine drug insert with the goal of informing clinical practice.

Methods

We extracted adverse events associated with gemcitabine use through 2023 using the Food and Drug Administration Adverse Event Reporting System (FAERS) database. Four algorithms (Reporting Odds Ratio, Proportional Reporting Ratio, Bayesian Confidence Propagation Neural Network, and Empirical Bayesian Geometric Mean) were employed to detect new AE signals. AEs were considered positive signals only if they were detected by all four algorithms.

Results

From 2014 to 2023, a total of 42,360 AEs were reported in 14,905 individuals following gemcitabine use. These AEs totaled 437 preferred terms (PTs) across 20 system organ classes (SOCs). We identified unexpected AEs related to the ocular disorders, the nervous system, and the ear and the labyrinth. The ocular organ system will present with retinopathy, purtscher retinopathy, choroidal effusion, amaurosis, necrotizing scleritis, etc. The nervous system may experience reversible posterior encephalopathy syndrome, cerebellar syndrome, cauda equina syndrome, athetosis, transverse myelitis, etc. The ears and labyrinth may exhibit ototoxicity.

Conclusion

Our study identified previously undetected signals following gemcitabine treatment, thereby providing new insights for future medication guidance.

KEYWORDS:

• Gemcitabine
• FAERS
• adverse event
• eye diseases
• nervous system

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

Peer reviewers on this manuscript have no relevant financial or other relationships to disclose.

Author contribution statement

Study concept and design: Xin Wang, Wang Zhang, and Yuhong Wang. Acquisition of the data: Lina Chang, Zhifang Ma, and Xin Jiang. Analysis and interpretation of the data: Xin Jiang, Lina Chang, Zhifang Ma and Yuanfang Jiang. Drafting of the manuscript: Wang Zhang, Yuhong Wang, Qiyue Wang and Hu Zhao. Statistical analysis: Lina Chang, Zhifang Ma and Xinli Jia. Technical support: Wang Zhang, Xin Jiang, Hu Zhao and Yue Chen. All the authors read and approved the final manuscript.

Acknowledgments

We would like to thank the U.S. Food and Drug Administration Adverse Event Reporting System.

Availability of data and material

The datasets for this study can be found in the https://fis.fda.gov/sense/app/95239e26-e0be-42d9-a960-9a5f7f1c25ee/sheet/33a0f68e-845c-48e2-bc81-8141c6aaf772/state/analysis.

Supplementary material

Supplemental data for this article can be accessed online at https://doi.org/10.1080/14740338.2023.2284989.

Additional information

Funding

This work was supported by the Fund Program for the Scientific Activities of Selected Returned Overseas Professionals in Shanxi Province; under Grant [20210005]; Shanxi Provincial Basic Applied Research Project under Grant [20210302124611]; and Research Project Supported by Shanxi Scholarship Council of China under Grant [2021-164].