Erschienen in:
Open Access
01.08.2018 | Commentary
Learning the effects of psychotropic drugs
during pregnancy using real-world safety data: a paradigm shift toward modern
pharmacovigilance
verfasst von:
Angela Lupattelli, Olav Spigset, Hedvig Nordeng
Erschienen in:
International Journal of Clinical Pharmacy
|
Ausgabe 4/2018
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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.