Document Detail

Transfer of risperidone and 9-hydroxyrisperidone into human milk.
MedLine Citation:
PMID:  14742766     Owner:  NLM     Status:  MEDLINE    
OBJECTIVE: To quantify the transfer of risperidone and its active metabolite 9-hydroxyrisperidone into breast milk, estimate the amount the infant receives, measure infant plasma concentrations, and clinically assess the safety of breast feeding during maternal risperidone administration. case summaries: The transfer of risperidone and 9-hydroxyrisperidone into milk was studied in 2 breast-feeding women and one woman with risperidone-induced galactorrhea. Plasma samples were available from 2 of the women and from both breast-fed infants. The milk/plasma concentration ratio determined in 2 women was <0.5 for both compounds. The calculated relative infant "doses" were 2.3%, 2.8%, and 4.7% (as risperidone equivalents) of the maternal weight-adjusted doses. Risperidone and 9-hydroxyrisperidone were not detected in the plasma of the 2 breast-fed infants studied, and no adverse effects were noted. DISCUSSION: Risperidone therapy is sometimes necessary in breast-feeding women, raising the issue of safety in the exposed infants. Our study shows that the relative infant dose is lower than the arbitrary 10% level of concern. The data provide clear guidance on infant exposure for the cases presented. CONCLUSIONS: Maternal risperidone therapy is unlikely to be a significant hazard for the breast-fed infant in the short term. Nevertheless, decisions on whether a woman may breast-feed should be made as an individual risk-benefit analysis.
Kenneth F Ilett; L Peter Hackett; Judith H Kristensen; Krishna S Vaddadi; Sharon J Gardiner; Evan J Begg
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Publication Detail:
Type:  Case Reports; Journal Article     Date:  2003-12-30
Journal Detail:
Title:  The Annals of pharmacotherapy     Volume:  38     ISSN:  1060-0280     ISO Abbreviation:  Ann Pharmacother     Publication Date:  2004 Feb 
Date Detail:
Created Date:  2004-01-26     Completed Date:  2004-05-11     Revised Date:  2004-11-17    
Medline Journal Info:
Nlm Unique ID:  9203131     Medline TA:  Ann Pharmacother     Country:  United States    
Other Details:
Languages:  eng     Pagination:  273-6     Citation Subset:  IM    
Pharmacology Unit, School of Medicine and Pharmacology, University of Western Australia, Crawley, Australia.
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MeSH Terms
Area Under Curve
Breast Feeding
Depression, Postpartum / drug therapy
Galactorrhea / chemically induced
Isoxazoles / blood,  metabolism*,  pharmacokinetics
Milk, Human / chemistry*
Pyrimidines / blood,  metabolism*,  pharmacokinetics
Risperidone / blood,  metabolism*,  pharmacokinetics
Reg. No./Substance:
0/Isoxazoles; 0/Pyrimidines; 106266-06-2/Risperidone; 144598-75-4/9-hydroxy-risperidone

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