Signal mining of adverse reactions in the antiemetic drug ondansetron during pregnancy: A real-world analysis of the FDA adverse event reporting system (FAERS)

ABSTRACT

Background

The aim of this study is to assess the risks associated with the use of ondansetron in pregnant women in real-world based on the Food and Drug Administration adverse Event Reporting System (FAERS).

Methods

The FAERS data from the 2017Q1 to the 2023Q1, which was used by the ratio-of-reporting (ROR) and Bayesian confidence interval progressive neural network (BCPNN) to assess the safety of ondansetron in pregnancy.

Results

A total of 15,727 pregnancy population reports were reported, with a total of 1,064 reports of adverse reactions with ondansetron as the primary suspected drug. Ondansetron was involved in a total of 10 system organ classifications (SOCs) of signal generation, and the top three signal intensities were Congenital, familial, and genetic disorders (ROR = 19.1, ROR₀₂₅ = 17.03; IC = 1.23, IC₀₂₅ = 1.16), Ear and labyrinth disorders (ROR = 17.11, ROR₀₂₅ = 12.46; IC = 1.22, IC₀₂₅ = 1.03), and Cardiac disorders (ROR = 9.48, ROR₀₂₅ = 8.38; IC = 1.12, IC₀₂₅ = 1.03); signals of adverse reactions obtained of 216, of which the main ones were Anhedonia (IC = 1.34, IC₀₂₅ = 1.08), Injury (IC = 1.34, IC₀₂₅ = 1.19), Left-to-right cardiac shunt (IC = 1.33, IC₀₂₅ = 1.05).

Conclusion

The adverse reactions of Ondansetron involve multiple systems and organs, which should cause clinical vigilance. However, due to the limitations of the data, the causal relationship and risk level of adverse reactions cannot be accurately inferred.

KEYWORDS:

• Pregnancy
• ondansetron
• adverse reactions
• FAERS
• signal detection

Declaration of interest

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.

Ethical approval

This paper does not contain any studies with human participants or animals performed by any of the authors.

Acknowledgments

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

Authors’ contributions

TTC and CXC were involved in the design of the study, took responsibility for the collection, integrity, and analysis of the data, and drafted the manuscript. JZ and HZ were involved in the conception and design of the study. All authors participated in revisions of the manuscript and approved the final version.

Availability of data and material

The database used in this study is publicly available on the website of https://fs.fda.gov/extensions/FPDQDE-FAERS/FPD-QDE-FAERS.html.

Reviewer disclosures

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

Supplementary material

Supplemental data for this article can be accessed online at https://doi.org/10.1080/14740338.2024.2386684

Additional information

Funding

This paper was funded by the Startup Fund for scientific research, Fujian Medical University [Grant number: 2023QH1187].