Abstracts

RATIONALE: Levetiracetam (LEV) is a new antiepileptic drug (AED) with favorable pharmacokinetics. However, up to now it was unknown whether LEV is excreted in human milk. We ware able to determine breast milk concentrations together with serum concentrations in a mother with epilepsy treated with LEV as well as in her neonate.
METHODS: Single case observation LEV breast milk and serum concentrations were measured by high pressure liquid chromatography.
RESULTS: A pregnant woman with epilepsy had been treated with phenytoin (PHT, 3x100 mg) as well as valproic acid (VPA, 4x500mg). After preterm labor, her baby was delivered at 34 weeks by caesarian section with nornal adaptation. The boy went through a transient respiratory distress syndrome in the first 3 days but was otherwise normal. Alimentation with mother-milk was started. Seven days after the delivery the mother had a generalized tonic clonic seizure and LEV was added to her other AEDs. Afterwards the boy became increasingly hypotonic and drank worse.
The breast milk concentrations of LEV determined in parallel to the serum concentration 3 hours after drug intake was 99 [mu]mol/l and 3 times higher than in in maternal serum (32 [mu]mol/l; milk/plasma-ratio 3.09). Ninetysix hours after the mother had stopped breastfeeding, LEV serum level in her baby was 6 [mu]mol/l and the boy could be discharged healthy 10 days later.
CONCLUSIONS: This clinical observation, which is in line with experimental data in lactating rats (with a milk/plasma-ratio of 2.6 24 hours post dose), strongly encourages either close monitoring of babies breastfeeded by LEV-treated mothers or avoidance of LEV during breastfeeding.
(Disclosure: Salary - UCB: Advisory board membership, Honoraria - UCB: Honoraria for Speaking)