Background: Anti-epileptic drug therapy is a great challenge for the practitioners during pregnancy and lactation. LEV is commonly prescribed to pregnant women, however, there are only few publications on its use during lactation with small number of participants.
Objective: To monitor LEV levels in breast-milk of epileptic mothers treated with LEV.
Methods: Breastfeeding women treated with LEV during pregnancy and after delivery were recruited. Milk sample was collected before administration of the drug and other samples were collected at time points of 1,3,6,9, and 12 hours after drug administration. Breastmilk and blood LEV levels were measured using HPLC.
Results: Fourteen breastfeeding women participated in the study. 9 children were fully breastfed, 4 partially breastfed. Daily dose of LEV was 2625 mg (range 1500-3750 mg). Relative Infant Dose (RID) was higher than 10 % in fully breastfed children AVG 14% in partial breast feeding 7.4%, in all samples CV% =39%, the excretion of the drug to the breastmilk is variable. No adverse reactions were observed in the breastfeed newborns, probably due to high apparent clearance (30-10%) of the drug in children. No adverse reactions were observed in the breastfeed infants.
Conclusions: Although the RID of LEV were found to be relatively high, no adverse reactions were observed in the infants. Nevertheless, further studies are needed to elucidate the high variability of LEV excretion into breastmilk.