Pregabalin Use in Lactating Mothers
Breastfeeding is not recommended during treatment with pregabalin due to the potential risk of tumorigenicity to the infant, as stated explicitly in the FDA drug label. 1
FDA Drug Label Recommendation
The FDA label for pregabalin provides clear guidance on this issue:
Pregabalin is detected in breast milk at average steady-state concentrations approximately 76% of maternal plasma levels, which represents substantial transfer into breast milk. 1
The estimated average daily infant dose from breast milk is 0.31 mg/kg/day, representing approximately 7% of the weight-adjusted maternal dose. 1
The FDA explicitly states: "Because of the potential risk of tumorigenicity, breastfeeding is not recommended during treatment with pregabalin." 1
Rationale for Caution
The primary concern is not acute toxicity but long-term risk:
Animal studies demonstrate a potential risk of tumorigenicity with pregabalin exposure via breast milk to the breastfed infant. 1
While available clinical data in patients over 12 years of age do not provide a clear conclusion about tumorigenicity risk in humans, the theoretical concern based on animal data drives the recommendation against breastfeeding. 1
Pharmacokinetic Data
Research confirms the FDA's concerns about significant milk transfer:
A pharmacokinetic study in 10 lactating women (≥12 weeks postpartum) receiving pregabalin 150 mg every 12 hours demonstrated that geometric mean pregabalin concentrations in breast milk were 53% of plasma Cmax and 76% of plasma AUC. 2
Approximately 574 μg of pregabalin (range 270-1720 μg) was recovered in breast milk over 24 hours, representing about 0.2% of the 300 mg daily maternal dose. 2
The estimated infant dose of 0.31 mg/kg/day represents 7% of the maternal weight-adjusted dose, which is considered a clinically significant exposure. 2
Clinical Decision-Making
If pregabalin is medically necessary for the mother:
Discontinue breastfeeding or choose an alternative medication with a more favorable lactation safety profile. 1
Consider alternative analgesics that are explicitly compatible with breastfeeding, such as ibuprofen, acetaminophen, or other NSAIDs, which have extensive safety data in lactation. 3
For neuropathic pain specifically, gabapentin may be considered as an alternative, though data during lactation remain limited and require careful monitoring. 4
Important Caveats
Unlike many medications where the concern is acute infant sedation or toxicity, the pregabalin concern is theoretical long-term tumorigenicity risk based on animal data. 1
The FDA recommendation represents a precautionary approach given the lack of long-term safety data in human infants exposed via breast milk. 1
No guideline from the Association of Anaesthetists or other major societies addresses pregabalin use during lactation, leaving the FDA drug label as the primary authoritative source. 5