Is Levetiracetam safe while breastfeeding?

Effects on the breastfed infant

A woman with epilepsy took phenytoin and valproic acid during pregnancy. She began breastfeeding on day 3 postpartum and had a seizure on day 7 postpartum. Levetiracetam (dosage not reported) was started and the infant became increasingly hypotonic and nursed poorly. Breastfeeding was discontinued and the infant was discharged from the hospital in a healthy condition.[ 2 ] Seven exclusively breastfed infants whose mothers were taking an average dosage of 2430 mg daily (range 1500 to 3500 mg daily) of levetiracetam plus various other anticonvulsants during pregnancy and lactation appeared healthy to the investigators throughout the 6 to 8 week study period. An eighth partially breastfed infant whose mother was taking valproate and oxcarbazepine started taking levetiracetam 9 months postpartum appeared healthy at 10 months of age.[ 4 ] No adverse effects were reported in 10 newborns who were 4 to 23 days old who were breastfed during maternal intake of levetiracetam 1000 to 3000 mg daily. Four mothers were also taking lamotrigine; 1 was taking carbamazepine; and one was taking tiagabine, clobazam and oxcarbazepine.[ 5 ] A woman with long-standing seizure disorder was taking primidone and levetiracetam became pregnant. The dosage of her medications were reduced during pregnancy to provide a levetiracetam serum concentration of 40.5 mg/L and a primidone (phenobarbital) serum concentration of 3.4 mg/L. The mother was instructed to discontinue breastfeeding after 3 days. The following day her infant developed withdrawal seizures. After reinstituting breastfeeding, the infant's seizures stopped and did not recur. The infant had no abnormal findings and was thriving and seizure free at 6 months of age.[ 12 ] The infants (including 3 preterm) of 18 nursing mothers who were taking levetiracetam and called the Pharmacovigilance Center in Lyon, France before breastfeeding were paired with 18 control infants. The median dosage was 1000 mg daily (range 500 to 3000 mg daily) and 8

Effects on milk supply

In a study of mothers taking levetiracetam during breastfeeding, 7 of 18 mothers discontinued or reduced breastfeeding because of poor milk output. The infant of one mother taking 3000 mg of levetiracetam daily plus clobazam had poor weight gain at day 15 of life.[ 10 ] A retrospective study of 102 women with epilepsy found that women taking levetiracetam were more likely to initiate and continue breastfeeding at 3 months postpartum than women taking lamotrigine.[ 16 ]

Levels in milk

In published reports of anticonvulsant use during breastfeeding, many women were taking a combination of anticonvulsants. Some other anticonvulsants (e.g., phenytoin, carbamazepine) stimulate the metabolism of other drugs including anticonvulsants, whereas others (e.g., valproic acid) inhibit the metabolism of other drugs. Therefore, the relationship of the maternal dosage to the concentration in breastmilk can be quite variable, making calculation of the weight-adjusted percentage of maternal dosage less meaningful than for other drugs in this database. Maternal Levels. A woman who was taking phenytoin, valproic acid and an unspecified dosage of levetiracetam had a milk levetiracetam level of 16.9 mg/L 3 hours after a dose, which was 3.1 times her simultaneous serum level.[ 2 ] Breastmilk levels in 12 mothers who were monitored at 4 days and 2 to 3 months postpartum were "significantly lower" than maternal blood levels. Further details were not published in the abstract.[ 3 ] Seven women taking an average of 2430 mg daily (range 1500 to 3500 mg daily) of levetiracetam plus various other anticonvulsants for epilepsy at the time of delivery had foremilk levels measured 3 to 5 days postpartum. Average milk levels were 12.5 mg/L (range 4.8 to 26 mg/L). Milk levels were again measured in 5 of the women plus another woman at one or more of the following times: 2, 4, 6 to 8 weeks and 4 or 10 months postpartum. Specific milk levels were not reported at those times, but the milk to plasma ratio was very similar at those times to the values at 3 to 5 days postpartum.[ 4 ] Eleven mothers who were 4 to 23 days postpartum and taking levetiracetam provided milk samples before nursing. Three women taking 100 mg daily had an average milk levetiracetam concentration of 8.68 mg/L (range 5.79 to 10.55 mg/L); 2 women taking 2000 mg daily had milk levels of 11.7 and 35.7 mg/L; 4 women taking 2500 mg daily had an average milk levetiracetam concentration of 13.95 mg/L (range 10 to 20.4 m

Alternatives LactMed lists

• Divalproex
• Gabapentin
• Lamotrigine
• Oxcarbazepine
• Phenytoin
• Valproic Acid