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Pregnancy and Perinatal Outcomes Following Exposure to Antineoplastic Agents Around Pregnancy within the US FDA Adverse Event Reporting System

医学 不良事件报告系统 怀孕 流产 不利影响 产科 先天性畸形 药理学 遗传学 生物
作者
Omar Abdel‐Rahman,Sunita Ghosh
出处
期刊:Future Oncology [Future Medicine]
卷期号:18 (21): 2635-2642 被引量:2
标识
DOI:10.2217/fon-2021-1255
摘要

Objective: To review pregnancy and perinatal outcomes associated with exposure to antineoplastic drugs around pregnancy as reported within the US FDA Adverse Event Reporting System (FAERS). Methods: The FAERS database was accessed and reports of exposure to antineoplastic drugs before/during pregnancy 2000-2020 were reviewed. An analysis of the frequency of different adverse pregnancy outcomes and perinatal outcomes was conducted for all agents as well as for specific categories of antineoplastic agents. Results: A total of 5312 reports of pregnancy exposure to antineoplastic drugs within the FAERS database were found to be eligible and were included in the current study. The most frequent adverse pregnancy outcomes included premature delivery (21.8%) and abortion (11.9%). The most frequent adverse perinatal outcomes included congenital malformations (15.9%) and fetal/neonatal death (12.9%). Conclusions: Within the limitations of the study (especially the lack of an accurate denominator), premature delivery, abortion, fetal/neonatal death and congenital malformations seemed to be the main risks associated with pregnancy exposure to antineoplastic drugs.The current study sought to review the reports of the exposure of pregnant women to anticancer medications in the US FDA Adverse Event Reporting System database. It suggested that premature delivery, abortion and congenital malformations are possible following these exposures.
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