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
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.
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.
- 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.