Risks to safety of Ondansetron preparations

doi:10.19803/j.1672-8629.20240458

Abstract

Abstract: Objective To analyze the risks to safety posed by Ondansetron in China in order to provide reference for clinical rational drug use. Methods The individual cases of adverse drug reactions retrieved from China adverse drug reaction database (from January 1, 2004 to September 30, 2022) and WHO Vigilyze (from inception to October 31, 2022) and other databases (from inception to December 31, 2023) were analyzed. Results In the serious adverse reaction report of ondansetron, adverse reactions such as anaphylactic shock, dyspnea, and liver dysfunction are prominent. ondansetron in pregnancy is associated with a risk of cleft lip and palate. If pregnant women use ondansetron before and after delivery, breastfeeding should be suspended. Conclusion Medical institutions should pay attention to the teratogenic risk of Ondansetron and weigh the risk and benifit before using it in pregnant women. The drug marketing authorization holder should update the drug labeling in time, strengthen the risk communication with medical institutions, and promote the rational use of medicines.

Key words: ondansetron, drug adverse reaction, fetus, teratogenic risk, cleft lip and palate, regulatory measures, instruction

CLC Number:

R994.11

MENG kangkang, XIA Yukun. Risks to safety of Ondansetron preparations[J]. Chinese Journal of Pharmacovigilance, 2024, 21(9): 1034-1038.

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URL: https://zgywjj.magtechjournal.com/EN/10.19803/j.1672-8629.20240458

https://zgywjj.magtechjournal.com/EN/Y2024/V21/I9/1034

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