Is agomelatine (antidepressant) safe to use during breastfeeding?

Agomelatine Use During Breastfeeding

Agomelatine should be used with caution during breastfeeding due to limited safety data, and consultation with a healthcare professional is required before use. 1

Safety Profile and Recommendations

• The FDA drug label explicitly states that breastfeeding women should consult a healthcare professional before using agomelatine 1
• There is very limited data on agomelatine use during breastfeeding, with most information on antidepressants in lactation focusing on SSRIs, SNRIs, and mirtazapine rather than newer agents like agomelatine 2
• When prescribing medications for breastfeeding mothers, clinicians must weigh the benefits of medication for the mother against potential risks to the infant 3

Pharmacological Considerations

• Agomelatine acts as a melatonergic MT1/MT2 receptor agonist and selective serotonin 5-HT2C receptor antagonist 4, 5
• Agomelatine has a relatively short half-life, which may be advantageous in reducing potential exposure to the breastfed infant 2
• The transfer of medications into breast milk generally depends on concentration gradients allowing passive diffusion of non-ionized, non-protein-bound drugs 3

Clinical Evidence

• A case report demonstrated the effectiveness of agomelatine in treating postpartum depression while suggesting safety during breastfeeding, taking advantage of the drug's short half-life to minimize infant exposure 2
• Most medicines can be used safely during breastfeeding at recommended doses, but exceptions requiring caution exist 6

Risk Minimization Strategies

• If agomelatine is deemed necessary for maternal health, infant exposure can be limited by:
  • Timing breastfeeding to avoid peak maternal serum drug concentration 3
  • Monitoring the infant for any adverse effects 2
  • Consulting specialized resources such as pharmacy departments at maternity hospitals for specific guidance 6

Alternative Considerations

• For breastfeeding women requiring antidepressant therapy, medications with more established safety profiles during lactation (such as certain SSRIs) might be considered as first-line options 2, 6
• The decision to use agomelatine should be made after careful consideration of the mother's mental health needs and the importance of breastfeeding for both mother and infant 2

Monitoring Recommendations

• If agomelatine is used during breastfeeding, the infant should be monitored for:
  • Changes in sleep patterns 4
  • Feeding behaviors 3
  • Any signs of adverse effects 2