International Journal of Clinical Pharmacy

, Volume 40, Issue 4, pp 783–786 | Cite as

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

  • Angela LupattelliEmail author
  • Olav Spigset
  • Hedvig Nordeng


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.


Pharmacovigilance Pregnancy Psychotropic drugs Real-world data Safety 



AL’s postdoctoral research fellowship is funded through the HN’s ERC Starting Grant “DrugsInPregnancy”, ERC-STG-2014 under grant agreement No 639377.

Conflicts of interest

The authors declare that they have no conflict of interest.


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Copyright information

© Springer International Publishing AG, part of Springer Nature 2018

Authors and Affiliations

  1. 1.PharmacoEpidemiology and Drug Safety Research Group, School of Pharmacy, and PharmaTox Strategic Research Initiative, Faculty of Mathematics and Natural SciencesUniversity of OsloOsloNorway
  2. 2.Department of Clinical PharmacologySt Olav’s University HospitalTrondheimNorway
  3. 3.Department of Clinical and Molecular MedicineNorwegian University of Science and TechnologyTrondheimNorway
  4. 4.Department of Child Health and DevelopmentNorwegian Institute of Public HealthOsloNorway

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