title: Lactation studies of anticonvulsants: a quality review.
abstract: OBJECTIVE
  The aim of this review was to investigate the quality of the current literature on the transfer of anticonvulsants to breast milk to provide an overview of which anticonvulsants are in need of further research.
  
  
  METHODS
  We reviewed the quality of the available lactation studies for 19 anticonvulsants against the guidelines of the Food and Drug Administration (FDA) and the International Lactation Consultant Association (ILCA).
  
  
  RESULTS
  Except for one study on lamotrigine and one case report on gabapentin, no study on anticonvulsants had both the absolute infant dose (AID) and milk to plasma ratio (M : P) correctly assessed. Only one study on carbamazepine, phenytoin and vigabatrin was found that correctly assessed the AID. The main cause for this low number is the lack of essential details in published studies, since 25 of 62 studies were case reports, letters or abstracts. Other major shortcomings were the lack of information on sampling methods, the number of samples in a particular dose interval as well as the low number of study participants.
  
  
  CONCLUSIONS
  The quality of the current literature on the transfer of anticonvulsants to breast milk is low, except for lamotrigine, which makes it hard to draw conclusions about the safety of the use of anticonvulsants during the lactation period. Therefore, further research is needed.
authors.affiliation: Department of Clinical Pharmacy, Isala Medical Centre, Dokter van Heesweg 2, 8025 AB, Zwolle, The Netherlands.
authors.forename: Douwe H
authors.initials: DH
authors.lastname: van der Meer
authors.forename: Andre
authors.initials: A
authors.lastname: Wieringa
authors.forename: Ilse
authors.initials: I
authors.lastname: Wegner
authors.forename: Bob
authors.initials: B
authors.lastname: Wilffert
authors.forename: Peter G J
authors.initials: PG
authors.lastname: Ter Horst
mesh_terms: D000927:Anticonvulsants / Q000009:adverse effects / Q000032:analysis* / Q000097:blood; D005060:Europe; D005260:Female; D006801:Humans; D007231:Infant, Newborn / Q000097:blood*; D007390:International Agencies; D007774:Lactation / Q000378:metabolism*; D008895:Milk, Human / Q000737:chemistry*; D017410:Practice Guidelines as Topic; D014481:United States; D014486:United States Food and Drug Administration
chemical_list: D000927:Anticonvulsants
keywords: anti-epileptic drugs; anticonvulsants; breast milk; human milk; lactation