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Br J Clin Pharmacol. 2019 Oct 21. doi: 10.1111/bcp.14145. [Epub ahead of print]

The pre- and post-authorisation data published by the European Medicines Agency on the use of Biologics during pregnancy and lactation.

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Department of Rheumatology, Erasmus University Medical Center, Rotterdam, The Netherlands.
Medicines Evaluation Board (MEB), Graadt van Roggenweg 500, 3531, AH, Utrecht, The Netherlands.
Academic Center of Inflammunity, Erasmus University Medical Center, Rotterdam, The Netherlands.
Netherlands Pharmacovigilance Centre Lareb, 's Hertogenbosch, The Netherlands.
Unit of Pharmacotherapy, -Epidemiology & -Economics, Faculty of Science and Engineering, University of Groningen, Groningen, The Netherlands.
Department of Gastroenterology and Hepatology, Erasmus University Medical Center, Rotterdam, The Netherlands.



The effects of biologics on reproduction/lactation are mostly unknown although many patients that receive biologics are women of reproductive age. The first objective of this study was to investigate the publicly available data on pregnancy/lactation before and after marketing authorization in Europe of biologics for the indications of rheumatologic inflammatory autoimmune diseases and inflammatory bowel disease. Secondary objectives included the assessment of the clinical relevance of the provided data and the comparison of the initial and the post-authorization data.


Initial and post-authorization data were extracted from the European Public Assessment Reports (EPARs) and the latest versions of Summary of Product Characteristics (SmPCs) using publicly available documents in European Medicines Agency's (EMA) website. Four sections were categorized regarding pregnancy outcomes: Pre-clinical/animal studies, human female fertility, pregnancy related outcomes and congenital malformations in the human foetus. Three sections were categorized regarding lactation outcomes: Pre-clinical/animal studies, excretion in human breast milk and absorption in children through breastfeeding. The clinical applicability of each category was scored by specified criteria, based on scientific literature, and further as defined by the authors.


From 16 included biologics, post-authorization data were delivered only for Adalimumab, Certolizumab pegol, Etanercept and Infliximab. From twelve remaining biologics limited data on pregnancy and lactation, during post-marketing period of 2-21 years became available.


In this article several suggestions are provided for improving a multidisciplinary approach to these issues. The initiation of suitable registries by marketing authorization holders and data transparency for clinicians and academics, are highly endorsed.


Biologics; gastroenterology; lactation; pregnancy; rheumatology


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