Is pregabalin (lyrica) contraindicated in nursing (breastfeeding) mothers?

Pregabalin Use During Breastfeeding

Pregabalin should be avoided during breastfeeding due to potential risks to the infant, including the risk of tumorigenicity. 1

Evidence on Pregabalin in Breast Milk

The FDA drug label provides the most definitive guidance on this matter:

• Pregabalin is detected in breast milk at average steady-state concentrations approximately 76% of those in maternal plasma 1
• The estimated average daily infant dose from breast milk is 0.31 mg/kg/day, which is approximately 7% of the maternal dose 1, 2
• Based on animal studies, there is a potential risk of tumorigenicity with pregabalin exposure via breast milk 1

Risk Assessment

The FDA explicitly states that "because of the potential risk of tumorigenicity, breastfeeding is not recommended during treatment with pregabalin" 1. This recommendation is based on:

1. Animal studies showing potential tumorigenicity risk
2. Significant transfer of pregabalin into breast milk
3. Insufficient clinical data to rule out risks to the breastfed infant

Clinical Considerations

When evaluating medication use during breastfeeding, several factors should be considered:

• Pregabalin has a relatively high transfer rate into breast milk (76% of maternal plasma levels) 1, 2
• The drug has a moderate molecular weight and is not highly protein-bound, contributing to its passage into breast milk 3
• While the pharmacokinetic study showed no immediate adverse effects in the infants, long-term safety data are lacking 2

Alternative Management Options

For nursing mothers requiring treatment for conditions typically managed with pregabalin:

1. For neuropathic pain:

   • Consider NSAIDs such as ibuprofen or diclofenac, which are considered safe during breastfeeding 4
   • Paracetamol (acetaminophen) is also considered safe 4

2. For seizure disorders:

   • Consult with a neurologist for alternative anticonvulsants with better safety profiles during lactation

Monitoring Recommendations

If, after a thorough risk-benefit assessment, pregabalin must be used:

• Monitor the infant for potential adverse effects including sedation, poor feeding, or developmental concerns
• Consider timing medication doses immediately after breastfeeding to minimize infant exposure 3
• If signs of infant toxicity appear, discontinue breastfeeding or the medication 5

Common Pitfalls to Avoid

1. Assuming all medications are contraindicated in breastfeeding: While many medications can be used safely during lactation, pregabalin specifically carries FDA warnings against use while breastfeeding 1

2. Failing to consider the risk-benefit ratio: The benefits of breastfeeding are significant, but in this case, the FDA has determined that the potential risks of pregabalin outweigh these benefits 1

3. Inadequate monitoring: If pregabalin must be used, close monitoring of the infant is essential to detect any adverse effects early

In conclusion, based on the FDA drug label, pregabalin should be avoided during breastfeeding due to potential tumorigenicity risks to the infant. Alternative medications with better safety profiles during lactation should be considered whenever possible.