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How Do We Best Detect Toxic Effects of Drugs Taken During Pregnancy?

A EuroMap Paper

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Abstract

It is a major clinical and public health problem that there is no clear strategy as to how we best make use of information obtained when pregnant women take drugs. For this reason, some pregnant women are not treated as they should be and some are given drugs they should not use. We suggest a monitoring system that combines some of the available datasets in Europe. Using these sources as a starting point, one can develop a system that has sufficient power to detect even rare diseases like congenital malformations and sufficient diversity to detect several possible outcomes from spontaneous abortions to childhood disorders. We also suggest that case-crossover designs should be used in case-control monitoring systems that carry a high risk of recall bias. These considerations are based upon our results from a European Union-funded concerted action called EuroMaP (Medicine and Pregnancy).

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Acknowledgements

This study was supported by the EuroMaP concerted action in the Biomed 2 work programme, contract no.BMH4 CT97-2430. Corinne S. de Vries has been funded by a Wellcome Trust Travelling Research Fellowship, grant no. 557509/Z/99/Z. The activities of the Danish Epidemiology Science Centre are financed by a grant from the Danish National Research Foundation.

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Authors and Affiliations

  1. The Danish Epidemiology Science Centre at the Department of Epidemiology and Social Medicine, University of Aarhus, Vennelyst Boulevard 6, Aarhus, 8000, Aarhus C, Denmark

    Jørn Olsen, Henrik Toft Sørensen, Charlotte Olesen & Lars Pedersen

  2. Foundation for the Community Control of Hereditary Diseases, Budapest, Hungary

    Andrew Czeizel

  3. Department of Clinical Epidemiology, University of Aarhus, Aarhus, Denmark

    Henrik Toft Sørensen

  4. Department of Gynaecology and Obstetrics, Aalborg Hospital, Aalborg, Denmark

    Gunnar Lauge Nielsen & Helle Larsen

  5. Social Pharmacy and Pharmacoepidemiology, University Centre of Pharmacy, Groningen, The Netherlands

    Lolkje T. T. W. de Jong van den Berg

  6. The Medical Birth Registry of Norway, University of Bergen, Haukeland Hospital, Bergen, Norway

    Lorentz M. Irgens & Rolv T. Lie

  7. Department of Pharmacoepidemiology & Public Health, European Institute of Health and Medical Sciences, University of Surrey, Surrey, UK

    Corinne S. de Vries

  8. Department of Clinical Pharmacology, Karolinska Institute, Huddinge University Hospital, Hoddinge, Sweden

    Ulf Bergman

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  1. Jørn Olsen
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  2. Andrew Czeizel
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  3. Henrik Toft Sørensen
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  4. Gunnar Lauge Nielsen
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  6. Lorentz M. Irgens
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  7. Charlotte Olesen
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  8. Lars Pedersen
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  9. Helle Larsen
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  10. Rolv T. Lie
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  11. Corinne S. de Vries
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  12. Ulf Bergman
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Correspondence to Jørn Olsen.

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Olsen, J., Czeizel, A., Sørensen, H.T. et al. How Do We Best Detect Toxic Effects of Drugs Taken During Pregnancy?. Drug-Safety 25, 21–32 (2002). https://doi.org/10.2165/00002018-200225010-00003

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