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Related Experiment Videos

Paroxetine in human milk.

E J Begg1, S B Duffull, D A Saunders

  • 1Clinical Pharmacology, Christchurch Hospital, Christchurch, New Zealand. evan.begg@chmeds.ac.nz

British Journal of Clinical Pharmacology
|July 27, 1999
PubMed
Summary

Paroxetine transfer to infants via breast milk is low, averaging 1.13-1.25% of the maternal dose. This study found paroxetine safe for breastfeeding infants, with undetectable infant plasma levels and no adverse effects observed.

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Area of Science:

  • Pharmacology
  • Neonatal studies
  • Maternal-fetal medicine

Background:

  • Paroxetine is commonly prescribed for depression and anxiety.
  • Assessing infant exposure to medications via breast milk is crucial for infant safety.
  • The maternal milk:plasma ratio (M/P) is a key metric for drug transfer.

Purpose of the Study:

  • To quantify infant exposure to paroxetine through breast milk.
  • To determine the maternal milk:plasma (M/P) ratio of paroxetine.
  • To compare different methods of M/P estimation and assess M/P variability.

Main Methods:

  • Two studies were conducted with nursing mothers on steady-state paroxetine treatment.
  • Study 1: Measured total milk paroxetine over 24h to calculate M/PAUC.

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  • Study 2: Used single milk and plasma samples around feeding times to directly calculate M/P.

    • Main Results:

    • Infant paroxetine dose was 1.13-1.25% of maternal weight-adjusted dose.
    • Mean M/PAUC was 0.39; mean single-point M/P was 0.96.
    • Paroxetine was undetectable in most infants; no adverse effects were reported.

    Conclusions:

    • Infant exposure to paroxetine via breast milk is low and generally considered safe.
    • The M/P ratio was consistent between studies, though single-point measurements showed wider variability.
    • Paroxetine use during breastfeeding is supported due to minimal infant transfer and lack of observed adverse events.