se of antiepileptic drugs (AED) during pregnancy – an evaluation of treatment patterns based on the German Embryotox database
- Conditions
- G40Epilepsy
- Registration Number
- DRKS00021001
- Lead Sponsor
- Pharmakovigilanzzentrum Embryonaltoxikologie Charité-Universitätsmedizin
- Brief Summary
INTRODUCTION: Epilepsy is a common neurological disease requiring long-term therapy also during pregnancy. Most studies on pregnancy outcomes in women with epilepsy are based on antiseizure medication (ASM) in monotherapy. However, about 20-30% of epilepsy patients require polytherapy and newer ASMs are an option, when seizure control is not achieved with first line ASMs. METHODS: Observational study evaluating the use of newer ASMs with marketing authorization since 2005 reported to the Embryotox Center of Clinical Teratology and Drug Safety in Pregnancy between 2004 and 2019. In addition, course and outcome of lacosamide exposed pregnancies were analysed. RESULTS: Our study confirms the increasing use of newer ASMs also in pregnant women. This is especially true for lacosamide, eslicarbazepine and brivaracetam with rising numbers of exposed pregnancies soon after marketing authorization. Analysis of 55 prospectively and 10 retrospectively ascertained lacosamide exposed pregnancies does not indicate increased risks of major birth defects or spontaneous abortion. However, bradycardia observed in 3 neonates might be related to prenatal lacosamide exposure. CONCLUSION: Available data do not support the assumption of lacosamide being a major teratogen. The increasing use of newer ASMs during pregnancy underscores the need for more studies to guide preconception counselling, especially for lacosamide, eslicarbazepine and brivaracetam.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- Female
- Target Recruitment
- 5000
Enrollment of pregnancies, of which neither the outcome nor pathological results of prenatal diagnostics were known at first contact to the German Embryotox Pharmacovigilance centre. Included are pregnancies with at least one antiepileptic drug exposure at conception in the study period 2000-2018.
none
Study & Design
- Study Type
- observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The use of antiepileptic drugs in pregnancy will be investigated. The aim is to evaluate the proportion of pregnant women with epilepsy who are exposed to non-recommended antiepileptic drugs at conception. In addition, the proportion of mono- and polytherapy in epilepsy treatment will be analysed. Moreover, changes in epilepsy treatments within the first trimester will be evaluated.
- Secondary Outcome Measures
Name Time Method Proportion of antiepileptic drugs used for treatment of psychiatric diseases, pain and migraine in pregnant women during the study period? Furthermore, the time gap between EU marketing authorization and first request to the German Embryotox pharmacovigilance institute will be analysed. If there are sufficient data on exposure to selected newer antiepileptic drugs, the course of these pregnancies will be descriptively evaluated.