Is Ganaxolone safe while breastfeeding?
Here is what LactMed, the Drugs and Lactation Database published by the U.S. National Institute of Child Health and Human Development (NICHD), reports about Ganaxolone. The text below is quoted from that source — it is not our own verdict.
Summary of use during breastfeeding
No published information is available on the clinical use of ganaxolone during breastfeeding. However, a study by the manufacturer indicates that amounts in breastmilk appear to be low and would not be expected to cause any adverse effects in breastfed infants.
Effects on the breastfed infant
Relevant published information was not found as of the revision date.
Effects on milk supply
Relevant published information was not found as of the revision date.
Levels in milk
Maternal Levels. The manufacturer reports that a study was conducted in 5 healthy adult lactating women treated with a single 300 mg oral dose of ganaxolone. The calculated maximum relative infant dose for ganaxolone was approximately 0.157 mg/kg daily based on an average milk intake of 150 mL/kg daily, which is less than 1% of the maternal dose, and approximately 0.24% the labeled pediatric dose of 63 mg/kg/day.
Infant Levels. Relevant published information was not found as of the revision date.
“No published information” means the studies do not exist yet — not that Ganaxolone is known to be harmful, and not that it is known to be safe. Your prescriber or pharmacist can weigh your baby's age and whether a better-studied alternative would do the same job. Worth asking before stopping a medicine you need.
Source: Drugs and Lactation Database (LactMed), National Institute of Child Health and Human Development (NICHD), via NCBI Bookshelf, record “Ganaxolone” (ganaxolone). LactMed on NCBI Bookshelf. LactMed is a registered trademark of the U.S. Department of Health and Human Services.
Educational summary of an authoritative source — not medical advice. Never start, stop, or change a medicine while breastfeeding without confirming with your doctor.