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

ABSTRACT

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.

KEYWORDS:

• Antipsychotic
• breastfeeding
• LAI
• LAI antipsychotics
• long-acting injectable antipsychotic
• pregnancy

Article highlights

• The clinical benefits of LAI-AP in the treatment of patients with SPMI are well established.

• In women with SPMI, pregnancy and postpartum should be considered high risk periods as SPMI may relapse and/or get worse.

• Abrupt discontinuation of any AP treatment may frequently lead to an SPMI relapse during the peripartum period, which may affect both maternal, obstetrician and fetal outcomes.

• There are substantially reassuring data about the safety in prescribing SGA during pregnancy, despite so far published literature regarding the use of LAI-SGA, during pregnancy and breastfeeding, which is still limited.

• No definitive remarks can be drawn up about the risk/benefit balance of prescribing LAI-AP in pregnancy and postpartum. A shared decision-making process should be incentivized by clinicians.

Declaration of interest

The authors have no relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending, or royalties.

Reviewer disclosures

Peer reviewers on this manuscript have no relevant financial or other relationships to disclose.

List of abbreviations

APs = Antipsychotic Drugs

FGA = First-generation Antipsychotic

LAI = Long-acting Injectable

MDD = Major Depressive Disorder

MM = Major Malformation

PC = Perinatal Complication

SGA = Second-generation Antipsychotic

SGA-LAI = Second-generation Antipsychotic Long-acting Injectable

SPMI = Severe and Persistent Mental Illness

Additional information

Funding

This paper was not funded.