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Antiepileptika bei Frauen im gebärfähigen Alter und in der Schwangerschaft

Vergleich der Fachinformationen in Deutschland und der Schweiz mit dem aktuellen Wissensstand

Antiepileptics in women of childbearing age and during pregnancy

Comparison of specialized information with the current state of knowledge in Germany and Switzerland

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Zusammenfassung

Hintergrund

Viele Heilberufler nutzen Fachinformationen als eine von verschiedenen möglichen Informationsquellen zu Risiken einer Arzneimittelanwendung bei Frauen im gebärfähigen Alter und in der Schwangerschaft. Ziel dieser Arbeit ist es, eine Übersicht über das teratogene Potenzial verschiedener Antiepileptika zu präsentieren und mit den Angaben ausgewählter Fachinformationen zu vergleichen.

Methoden

Es wurde eine Literaturrecherche zum teratogenen Risiko von 19 Antiepileptika durchgeführt. Die Ergebnisse wurden mit den Angaben der Fachinformationen von 38 in der Schweiz und in Deutschland erhältlichen Fertigarzneimitteln verglichen.

Ergebnisse

In allen Fachinformationen wird das teratogene Risiko anhand epidemiologischer Daten diskutiert. Eine Quantifizierung des Fehlbildungsrisikos und die Anzahl dokumentierter Schwangerschaften fehlen jedoch meistens. Angaben zur Notwendigkeit der Überwachung von Plasmaspiegeln während der Schwangerschaft mit etwaiger Dosisanpassung fehlen in fünf schweizer und zwei deutschen Fachinformationen.

Diskussion

Die Angaben in den Fachinformationen der untersuchten Antiepileptika zur Anwendung bei Frauen im gebärfähigen Alter und in der Schwangerschaft sind heterogen und entsprechen überwiegend nicht dem aktuellen Kenntnisstand. Eine durch die zuständigen Behörden angestoßene Überarbeitung der Fachinformationen scheint notwendig zu sein, damit diese Dokumente für Heilberufler tatsächlich von Nutzen sein können.

Summary

Background

Healthcare professionals regularly read the summary of product characteristics (SmPC) as one of the various sources of information on the risks of drug use in women of childbearing age and during pregnancy. The aim of this article is to present an overview of the teratogenic potential of various antiepileptic drugs and to compare these data with the information provided by the SmPCs.

Methods

A literature search on the teratogenic risks of 19 antiepileptic agents was conducted and the results were compared with the information on the use in women of childbearing age and during pregnancy provided by the SmPCs of 38 commercial products available in Switzerland and Germany.

Results

The teratogenic risk is discussed in all available SmPCs. Quantification of the risk for birth defects and the numbers of documented pregnancies are mostly missing. Reproductive safety information in SmPCs showed poor concordance with risk levels reported in the literature. Recommendations concerning the need to monitor plasma levels and possibly perform dose adjustments during pregnancy to prevent treatment failure were missing in five Swiss and two German SmPCs.

Discussion

The information regarding use in women of childbearing age and during pregnancy provided by the SmPCs is heterogeneous and poorly reflects the current state of knowledge. Regular updates of SmPCs are warranted in order for these documents to be of reliable use for health care professionals.

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Einhaltung ethischer Richtlinien

Interessenkonflikt. U. Winterfeld, V. Gotta, L.E. Rothuizen, A. Panchaud, A.O. Rossetti und T. Buclin geben an, dass kein Interessenkonflikt besteht. Dieser Beitrag beinhaltet keine Studien an Menschen oder Tieren.

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Authors and Affiliations

  1. Division de Pharmacologie Clinique, Swiss Teratogen Information Service, Centre Hospitalier Universitaire Vaudois (CHUV) et Université de Lausanne, Rue du Bugnon 17/01/104, 1011, Lausanne, Schweiz

    U. Winterfeld PhD, V. Gotta, L.E. Rothuizen, A. Panchaud & T. Buclin

  2. Section des sciences pharmaceutiques, Faculté des sciences, Université de Genève, Université de Lausanne, Lausanne, Schweiz

    A. Panchaud

  3. Département des Neurosciences Cliniques, Centre Hospitalier Universitaire Vaudois (CHUV) et Université de Lausanne, Lausanne, Schweiz

    A.O. Rossetti

Authors
  1. U. Winterfeld PhD
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  2. V. Gotta
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  3. L.E. Rothuizen
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  4. A. Panchaud
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  5. A.O. Rossetti
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  6. T. Buclin
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Corresponding author

Correspondence to U. Winterfeld PhD.

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Winterfeld, U., Gotta, V., Rothuizen, L. et al. Antiepileptika bei Frauen im gebärfähigen Alter und in der Schwangerschaft. Nervenarzt 85, 738–746 (2014). https://doi.org/10.1007/s00115-014-4091-x

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  • DOI: https://doi.org/10.1007/s00115-014-4091-x

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