Severe and persistent mental illness (SPMI) in pregnancy and breastfeeding: focus on second-generation long acting injectable antipsychotics.

Introduction: Pregnant women and fetuses are more likely than ever to be exposed to antipsychotic drugs (APs) during pregnancy and postpartum period. Second-generation APs (SGA) are increasingly used among women in reproductive age. Key outcomes (i.e., congenital malformations, pregnancy and maternal outcomes, neonatal/infant risks, and developmental/long-term outcomes) following the exposure to APs remain limited in number and size and yield of inconsistent findings overall, particularly regarding long-acting injectable AP (LAI-APs) formulations.Areas covered: The review aims at providing a summary of current knowledge on potential risks and safety profile of LAI-APs during pregnancy and breastfeeding, specifically focusing on SGA.Expert opinion: The management of safety and tolerability of long-acting injectable AP (LAI-APs) is far from having solid scientific evidence. In fact, due to ethical reasons, there is a lack of randomized clinical trials that limits the reliability and generalizability of the available data on LAI-APs safety profile during the perinatal period, being limited in the scientific literature only to isolated case reports. Therefore, it seems to be important for the future pathways to perinatal mental health care, providing a network of specialized clinicians and systematically collecting data of pregnant/puerperal women on oral and/or LAI APs-therapy about mother and infant outcomes.