Is Levroxa Safe in Breastfeeding

I am a breastfeeding mother and i want to know if it is safe to use Levroxa? Is Levroxa safe for nursing mother and child? Does Levroxa extracts into breast milk? Does Levroxa has any long term or short term side effects on infants? Can Levroxa influence milk supply or can Levroxa 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 Levroxa and Phenobarbital in pregnancy ocurred. Symptoms disappeared after initiation of breastfeeding.

Maternal doses of Levroxa 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 Levroxa 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 Levroxa 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. Levroxa (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 Levroxa 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 Levroxa 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 Levroxa 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 Levroxa became pregnant. The dosage of her medications were reduced during pregnancy to provide a Levroxa 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 Levroxa 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 Levroxa 3000 mg daily plus clobazam was hospitalized for sedation, vomiting, and weight loss, and improved rapidly after breastfeeding discontinuation. Another infant exposed to Levroxa and clobazam had poor weight gain, but it appeared to be caused by poor milk production. Other than these infants, all Levroxa 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 Levroxa 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 Levroxa 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 Levroxa during breastfeeding, 7 of 18 mothers discontinued or reduced breastfeeding because of poor milk output. The infant of one mother taking 3000 mg of Levroxa daily plus clobazam had poor weight gain at day 15 of life.[8]