Pregnancy and perinatal outcomes following exposure to antineoplastic agents around pregnancy within the US FDA Adverse Event Reporting System

Plain language summary 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. 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.