Gabapentin Use During Lactation
Gabapentin can be used during breastfeeding with infant monitoring, as it is secreted into breast milk at levels that could expose a nursing infant to approximately 1 mg/kg/day, but the benefits of breastfeeding should be weighed against unknown risks to the infant. 1
FDA-Approved Labeling Guidance
- The FDA label explicitly states that gabapentin is secreted into human milk following oral administration, with potential infant exposure of approximately 1 mg/kg/day 1
- Because the effect on the nursing infant is unknown, gabapentin should be used in women who are nursing only if the benefits clearly outweigh the risks 1
- The FDA classifies gabapentin as potentially "developmentally toxic" based on preclinical data, raising concerns about widespread use particularly during pregnancy and lactation 2
Clinical Safety Profile
- Gabapentin is considered compatible with breastfeeding but with a less documented safety profile compared to older antiepileptic drugs like carbamazepine, valproic acid, and phenytoin 3
- Limited clinical data are available for gabapentin during lactation, and no clear-cut recommendations can be made until further data are present 4
- If breastfeeding continues during gabapentin treatment, the infant should be monitored for possible adverse effects 4
Practical Monitoring Recommendations
- Observe the breastfed infant for signs of sedation, poor feeding, and developmental concerns while the mother is taking gabapentin 5
- Infant monitoring for potential adverse effects is advisable when the mother is taking gabapentin 5
- Consider monitoring infant serum drug concentrations if there are concerns about infant exposure, though this is advisable but not compulsory 5
Emerging Safety Concerns
- Recent evidence reveals concerns regarding gabapentin safety, particularly for neonatal exposure via breastmilk 2
- Concerns have been raised about atypical or difficult-to-control withdrawal signs and symptoms in neonates exposed to gabapentin, including those dually exposed to opioids 2
- The current literature suggests that gabapentin use should be considered with caution during the postpartum period 2
Risk-Benefit Considerations
- Women should not be discouraged from breastfeeding while taking compatible medications, given the substantial benefits of breastfeeding for both infant and maternal health 6
- The potential risk of drug therapy should be weighed against the risk of untreated maternal symptoms 6
- Breast milk has considerable advantages over formula milk, and the benefits of continuing breastfeeding should always be taken into consideration in the risk-benefit analysis 4