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Transfer of Risperidone and 9-Hydroxyrisperidone into Human Milk

Associate Professor of Pharmacology, Pharmacology Unit, School of Medicine and Pharmacology, University of Western Australia, Crawley, Australia

L Peter Hackett, MRSC

Research Scientist, Clinical Pharmacology and Toxicology Laboratory, The Western Australian Centre for Pathology & Medical Research, Nedlands, Australia

Judith H Kristensen, BPharm

Senior Pharmacist, Pharmacy Department, King Edward Memorial and Princess Margaret Hospitals, Women's and Children's Health Service, Subiaco, Australia

Krishna S Vaddadi, FRANZCP

Associate Professor in Psychiatry, Department of Psychological Medicine, Monash University, Clayton, Australia

Sharon J Gardiner, MClinPharm

Chief Drug Information Pharmacist, Department of Clinical Pharmacology, Christchurch Hospital, Christchurch, New Zealand

Evan J Begg, MD

Professor of Medicine/Clinical Pharmacology, Christchurch School of Medicine and Health Sciences, University of Otago, Christchurch Hospital

Reprints: Kenneth F Ilett PhD, Pharmacology Unit, School of Medicine and Pharmacology, University of Western Australia, Crawley, Australia, fax 618/9346 3469, kilett{at}receptor.pharm.uwa.edu.au

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.

Key Words: breast milk, 9-hydroxyrisperidone, risperidone

Published Online, December 30, 2003. www.theannals.com, DOI 10.1345/aph.1D326

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