title: [Antiepileptics in women of childbearing age and during pregnancy: comparison of specialized information with the current state of knowledge in Germany and Switzerland].
abstract: 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.
  
  
  CONCLUSIONS
  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.
authors.affiliation: 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, ursula.winterfeld@chuv.ch.
authors.forename: U
authors.initials: U
authors.lastname: Winterfeld
authors.forename: V
authors.initials: V
authors.lastname: Gotta
authors.forename: L E
authors.initials: LE
authors.lastname: Rothuizen
authors.forename: A
authors.initials: A
authors.lastname: Panchaud
authors.forename: A O
authors.initials: AO
authors.lastname: Rossetti
authors.forename: T
authors.initials: T
authors.lastname: Buclin
mesh_terms: D000293:Adolescent; D000328:Adult; D000927:Anticonvulsants / Q000009:adverse effects* / Q000627:therapeutic use*; D004348:Drug Labeling / Q000706:statistics & numerical data*; D004827:Epilepsy / Q000188:drug therapy*; D019317:Evidence-Based Medicine; D005260:Female; D005858:Germany; D006801:Humans; D008875:Middle Aged; D063046:Patient Medication Knowledge / Q000379:methods / Q000706:statistics & numerical data; D011247:Pregnancy; D011248:Pregnancy Complications / Q000139:chemically induced* / Q000628:therapy*; D013557:Switzerland; D016387:Women's Health / Q000706:statistics & numerical data; D055815:Young Adult
chemical_list: D000927:Anticonvulsants