Paroxetine Levels in Postpartum Depressed Women, Breast Milk, and Infant Serum
J Clin Psychiatry 2000;61(11):828-832
© Copyright 2016 Physicians Postgraduate Press, Inc.
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Background: The purpose of this study was
to determine the concentrations of paroxetine in maternal serum,
breast milk, and infant serum samples and to estimate infant
exposure through breastfeeding.
Method: A total of 25 sample sets was
obtained: 1 sample set each from 23 mother-infant dyads and 2
sample sets from 1 mother-infant dyad. All mothers met DSM-IV
criteria for major depressive disorder. The maternal fixed dosage
of paroxetine was 10, 20, or 40 mg/day for a minimum of 30 days
before the samples were drawn. Samples were collected 6 hours
after dose intake, and the concentration of paroxetine in each
sample was determined using gas chromatography/mass spectrometry.
The analytic method employed in this study is the most sensitive
to date, with the ability to detect drug concentrations as low as
Results: Detectable levels of paroxetine
were present in all maternal serum samples and in 24 of the 25
breast milk samples. In all of the infant serum samples, the
paroxetine concentrations were below the lower limit of
quantification. No unusual adverse effects were reported in any
of the infants.
Conclusion: The results of this study
demonstrate that paroxetine, like the other selective serotonin
reuptake inhibitors studied to date, is excreted into the breast
milk of nursing mothers. The mean infant dose of paroxetine was
1.1% of the maternal dose. Although no short-term adverse effects
were reported in any of the infants in this study, future studies
are needed to address a more systematic method for observing and
recording any adverse effects. In addition, future studies should
incorporate follow-up studies in order to evaluate possible
long-term effects of paroxetine exposure.