Zusammenfassung
Hintergrund
Die Datenlage zum Übergang von Antiepileptika in die Muttermilch und etwaige Konsequenzen für gestillte Kinder ist begrenzt. Angesichts dieser Unsicherheit, wird einer Vielzahl von Patientinnen vom Stillen abgeraten. Ziel dieser Arbeit war es, die verfügbaren Daten zur Anwendung von Antiepileptika in der Stillzeit umfassend zu überprüfen und mit den Angaben der Fachinformationen der Fertigarzneimittel zu vergleichen. Weiterhin werden Empfehlungen für die Anwendung dieser Arzneimittel in der Stillzeit geben.
Methodik
Es wurde eine systematische Literaturrecherche zur Anwendung von 23 Antiepileptika in der Stillzeit durchgeführt. Die Kompatibilität jedes Antiepileptikums mit dem Stillen wurde mithilfe einer von uns entwickelten und validierten Skala sowohl auf der Grundlage der Literaturrecherche als auch der Empfehlungen der Fachinformationen abgeschätzt und verglichen.
Ergebnisse
Es wurden 75 Artikel mit relevanten Daten zu 15 Antiepileptika beim Stillen ausgewertet. Der Vergleich zwischen den Werten der Kompatibilitätsskala der Literaturrecherche und der Fachinformationen zeigte einen sehr niedrigen Grad der Übereinstimmung (gewichtetes Kappa: 0,08).
Diskussion
Phenobarbital, Primidon, Carbamazepin, Valproat und Levetiracetam sind wahrscheinlich mit dem Stillen kompatibel. Die Behandlung mit Phenytoin, Ethosuximid, Clonazepam, Oxcarbazepin, Vigabatrin, Topiramat, Gabapentin, Pregabalin, Lamotrigin und Zonisamid während des Stillens ist möglich; gestillte Säuglinge sollten jedoch sorgfältig auf Nebenwirkungen überwacht werden. Da die Daten zu Mesuximid, Clobazam, Rufinamid, Felbamat, Lacosamid, Sultiam, Perampanel und Retigabin für eine Risikobewertung unzureichend sind, ist die Anwendung in der Stillzeit prinzipiell nicht zu empfehlen und sollte im Einzelfall sorgfältig evaluiert werden. In der Praxis ist es ratsam, für jede Mutter, die ein Antiepileptikum einnimmt und ihr Kind stillen möchte, eine Nutzen-Risiko-Analyse durchzuführen, um alle relevanten Risikofaktoren in der individuellen Beratung der Patientin zu berücksichtigen.
Abstract
Background
Knowledge about the passage of various antiepileptic drugs into breast milk and its consequences for the infant is limited. Faced with this uncertainty, breastfeeding is often discouraged for these patients. The aim of this study was to comprehensively review the available data regarding antiepileptic drugs during breastfeeding, to compare these data with information provided by the summary of product characteristics (SmPCs), and to provide recommendations for the use of these drugs in breastfeeding women.
Material and methods
We performed a systematic literature review on breastfeeding data for 23 antiepileptic drugs. A breastfeeding compatibility score was developed and validated. The estimated score based on the literature review was compared with the estimated score based on recommendations provided by the SmPCs.
Results
We identified 75 articles containing exposure and safety data for 15 antiepileptic agents during breastfeeding. The comparison between the score values based on the literature review and on the SmPCs revealed a very low degree of concordance (weighted kappa: 0.08).
Conclusion
Phenobarbital, primidone, carbamazepine, valproate and levetiracetam are probably compatible with breastfeeding. Treatment with phenytoin, ethosuximide, clonazepam, oxcarbazepine, vigabatrin, topiramate, gabapentin, pregabalin, lamotrigine and zonisamide can be authorized during breastfeeding, provided breastfed infants are carefully monitored for side effects. Since data on the use of mesuximide, clobazam, rufinamide, felbamate, lacosamide, sultiame, perampanel and retigabine are insufficient to adequately assess the risk for breastfed infants, use in breastfeeding women is in principle not recommended and should be carefully evaluated on a case by case basis. In practice, a risk-benefit analysis should be performed for each mother under antiepileptic treatment wishing to breastfeed her child, so that individual risk factors can adequately be taken into account when counseling the patient.
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M. Crettenand, A.O. Rossetti, T. Buclin und U. Winterfeld geben an, dass kein Interessenkonflikt besteht.
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Crettenand, M., Rossetti, A.O., Buclin, T. et al. Antiepileptika in der Stillzeit. Nervenarzt 89, 913–921 (2018). https://doi.org/10.1007/s00115-018-0496-2
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DOI: https://doi.org/10.1007/s00115-018-0496-2