Is UCB L059 Safe in Breastfeeding

I am a breastfeeding mother and i want to know if it is safe to use UCB L059? Is UCB L059 safe for nursing mother and child? Does UCB L059 extracts into breast milk? Does UCB L059 has any long term or short term side effects on infants? Can UCB L059 influence milk supply or can UCB L059 decrease milk supply in lactating mothers?

Piracetam analog with nootropic and anti-epileptic effect. Authorized for use in children in Europe. Excreted into breast milk but infant serum levels were shown to be low. No other side effect than one case of hypotonia in a 7 days old premature whose mother was also on anti-epileptic medication. Seizures along with neonatal abstinence syndrome in a botlle fed neonate whose mother had taken UCB L059 and Phenobarbital in pregnancy ocurred. Symptoms disappeared after initiation of breastfeeding.

Maternal doses of UCB L059 up to 3500 mg daily produce low levels in milk and would not be expected to cause any adverse effects in breastfed infants, especially if the infant is older than 2 months. If UCB L059 is required by the mother, it is not a reason to discontinue breastfeeding. However, the infant should be monitored for drowsiness, adequate weight gain, and developmental milestones, especially in younger, exclusively breastfed infants and when using combinations of anticonvulsants. Maternal serum level monitoring and dosage adjustment is advisable in the early postpartum period if the drug was taken throughout pregnancy and breastfeeding.[1] Some evidence suggests that UCB L059 might reduce the maternal breastmilk supply in some women.

An woman with epilpesy took phenytoin and valproic acid during pregnancy. She began breastfeeding on day 3 postpartum and had a seizure on day 7 postpartum. UCB L059 (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 UCB L059 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 UCB L059 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 UCB L059 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 UCB L059 became pregnant. The dosage of her medications were reduced during pregnancy to provide a UCB L059 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.[9] The infants (including 3 preterm) of 18 nursing mothers who were taking UCB L059 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 were receiving at least one additional anticonvulsant. The median duration of breastfeeding was 40 days (range 10 to 224 days), and 13 newborns were exclusively breastfed. Breastfed infants were followed for a median of 9.1 months (range 0.75 to 73 months). One 25-day-old infant whose mother was taking UCB L059 3000 mg daily plus clobazam was hospitalized for sedation, vomiting, and weight loss, and improved rapidly after breastfeeding discontinuation. Another infant exposed to UCB L059 and clobazam had poor weight gain, but it appeared to be caused by poor milk production. Other than these infants, all UCB L059 and control infants grew and developed normally.[8] A pregnant woman suffered blood clots in the sinuses and 2 small intracranial hemorrhages followed by status epilepticus at 8 weeks of gestation. She was treated with UCB L059 1000 mg and lacosamide 100 mg twice daily as well as enoxaparin and labetalol for the rest of her pregnancy and postpartum. Her infant was delivered at 36 weeks gestation and about 50% breastfed for the first days of life. The infant was sleepy and fed poorly, but pauses in breastfeeding did not improve the infant's condition. Breastfeeding was discontinued at 15 days postpartum and the infant gradually improved. The infant showed normal development at 7 months of age.[6] A mother with epilepsy took UCB L059 2000 mg daily plus lacosamide 200 mg twice daily while breastfeeding their infants. She breastfed (extent not stated) her infant for 7 months with no infant adverse effects at 24 months of age.[10]

In a study of mothers taking UCB L059 during breastfeeding, 7 of 18 mothers discontinued or reduced breastfeeding because of poor milk output. The infant of one mother taking 3000 mg of UCB L059 daily plus clobazam had poor weight gain at day 15 of life.[8]