From the FDA Drug Label
A pharmacokinetic study in lactating women detected pregabalin in breast milk at average steady state concentrations approximately 76% of those in maternal plasma. The estimated average daily infant dose of pregabalin from breast milk (assuming mean milk consumption of 150 mL/kg/day) was 0. 31 mg/kg/day, which on a mg/kg basis would be approximately 7% of the maternal dose. Based on animal studies, there is a potential risk of tumorigenicity with pregabalin exposure via breast milk to the breastfed infant. Because of the potential risk of tumorigenicity, breastfeeding is not recommended during treatment with pregabalin.
Pregabalin is not recommended during breastfeeding due to the potential risk of tumorigenicity with exposure via breast milk to the breastfed infant 1.
From the Research
Pregabalin (Lyrica) is generally considered safe during breastfeeding, with the benefits of breastfeeding likely outweighing the potential risks for most women taking Lyrica, as limited amounts of pregabalin pass into breast milk, with infants typically receiving less than 7% of the mother's weight-adjusted dose 2.
Key Considerations
- The amount of medication excreted in breast milk depends on factors such as dosing, chemical characteristics of the medication, and maternal pharmacokinetics 3.
- Neonatal drug exposure is usually assessed by calculating an expected total infant daily dose through breast milk and comparing it to the normal therapeutic dose 3.
- The safety profile of pregabalin improves with older infants compared to newborns, as older babies can metabolize medications more effectively 2.
- Healthcare providers may recommend continuing breastfeeding while using the lowest effective dose of Lyrica, balancing treating the mother's condition while minimizing infant exposure 2.
Monitoring and Precautions
- Mothers should monitor their breastfed infants for drowsiness, poor feeding, or irritability, which could indicate medication effects 2.
- Individual circumstances may affect recommendations, and healthcare providers should discuss specific situations with mothers before making decisions about medication use during breastfeeding 2.
- Risk assessment should not only be based on the drug's potential risk for the breastfed infant but should also take into account the benefits associated with breastfeeding, the risks of untreated maternal disease, and the maternal willingness to breastfeed 2.