Learning the effects of psychotropic drugs during pregnancy using real-world safety data: a paradigm shift toward modern pharmacovigilance

Angela Lupattelli,Hedvig Nordeng,Olav Spigset

doi:10.1007/s11096-018-0672-2

Abstract

The growing evidence on psychotropic drug safety in pregnancy has been possible thanks to the increasing availability of real-world data, i.e. data not collected in conventional randomised controlled trials. Use of these data is a key to establish psychotropic drug effects on foetal, child, and maternal health. Despite the inherent limitations and pitfalls of observational data, these can still be informative after a critical appraisal of the collective body of evidence has been done. By valuing real-world safety data, and making these a larger part of the regulatory decision-making process, we move toward a modern pregnancy pharmacovigilance. The recent uptake of real-world safety data by health authorities has set the basis for an important paradigm shift, which is integrating such data into drug labelling. The recent safety assessment of sodium valproate in pregnant and childbearing women is probably one of the first examples of modern pregnancy pharmacovigilance.

Highlights

Perinatal psychiatric disorders occur in one out of five women, and among these, a substantial number may require treatment with psychotropic drugs, even during pregnancy [1]
The prevalence of antidepressant use increased from 1% in the nineties, to a current 3% in Europe and 8% in the USA [2, 3]
Pharmacotherapy with psychotropic drugs during pregnancy involves weighing the possible risk of foetal exposure to the drug against the potential adverse effects of sub-optimally treated maternal psychiatric illness to both the mother and child

Summary

Introduction

Perinatal psychiatric disorders occur in one out of five women, and among these, a substantial number may require treatment with psychotropic drugs, even during pregnancy [1] Gestational use of these drugs has been on the rise in the last decades. Pharmacotherapy with psychotropic drugs during pregnancy involves weighing the possible risk of foetal exposure to the drug against the potential adverse effects of sub-optimally treated maternal psychiatric illness to both the mother and child. To guide such decisions, it is critical to provide sound data about psychotropic drug safety in pregnancy and to appraise the collective body of evidence.

The importance of pharmacoepidemiological pregnancy studies

Findings

Modern pregnancy pharmacovigilance?