Drugs and Pregnancy in a Real-Life Setting: Maternal, Fetal and Neonatal Safety Outcomes

Background/Introduction: Pregnant women have been historically representing the frailest population in terms of safety profile of drugs and vaccines, being identified as vulnerable population in need of special protections in clinical research. Objective/Aim: We aim to identify: the amount of ICSRs reporting ADRs related to pregnancy, fetal and neonatal outcomes; drugs most commonly reported as suspected in ICSRs reporting pregnancy, fetal and neonatal outcomes; types ADRs related to pregnancy, fetal and neonatal outcomes. Methods: We analyzed ICSRs that were sent from January 2001 until March 2021 to the Campania regional Center of Pharmacovigilance (South of Italy) describing the occurrence of ADRs belonging to the SOCs Pregnancy, puerperium and perinatal conditions, Surgical and medical procedures and Congenital, familial and genetic disorders. We also retrieved ICSRs describing the occurrence of any type of ADRs in neonates (aged < 29 days). Results: From January 2001 to March 2021, 29 ICSRs reported ADRs belonging to the analysed SOCs or described the occurrence of any type of ADRs in neonates. Almost 75% of ICSRs fell into the following categories: spontaneous abortion (n = 9; 31%), congenital disorders (n = 8; 27.5%) and other disorders affecting the mother or the baby (n = 5; 17.2%); the remaining 25% of ICSRs fell into the remaining categories (4 ICSRs in unintended pregnancy, 2 in preterm birth e 1 in ectopic pregnancy). All ADRs were considered to be serious. Almost 90% of ICSRs were reported by healthcare professionals. Drugs most commonly reported as suspected (> 40% of ICSRs) were those indicated for the treatment of autoimmune conditions, including natalizumab (4 ICSRs), methotrexate, ocrelizumab, alemtuzumab and glatiramer acetate (2 ICSRs each one). Conclusion: The spontaneous reporting system is a valuable tool for the safety monitoring of medicines and vaccines especially in frail population that are normally excluded by the premarketing clinical trials, such as pregnant women and children. In addition, among ADRs that were evaluated in this study, teratogenesis is still of great concern considering that animal studies that focus are rarely adequate to predict human outcomes and that clinical studies in humans systematically exclude pregnant women and ensure that those of childbearing potential do not become pregnant during the period of drug exposure. Therefore, data from ICSRs reporting ADRs occurring in pregnant women represent the ma