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Journal of Human Lactation
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The Amount of Fluvoxamine in Milk Is Unlikely to Be a Cause of Adverse Effects in Breastfed Infants

Judith H. Kristensen, BPharm

Department of Pharmacy, King Edward Memorial and Princess Margaret Hospitals, Bagot Road, Subiaco 6008, Western Australia.

L. Peter Hackett, LRSC

Clinical Pharmacology and Toxicology Laboratory at the Western Australia Centre for Pathology and Medical Research, Nedlands, Western Australia.

Rolland Kohan, MB, BS, FRACP

Department of Neonatal Services at the King Edward Memorial and Princess Margaret Hospitals, Subiaco, Western Australia.

Michael Paech, MB, BS, DA, DRLOG, FRCA, FANZCA

Department of Anaesthesia at the King Edward Memorial and Princess Margaret Hospitals, Subiaco, Western Australia.

Kenneth F. Ilett, PhD, BPharm

Department of Pharmacology at the University of Western Australia, Nedlands, Western Australia.

The aim of this study was to characterize milk/plasma (M/P) ratio, as well as relative infant dose and well-being, in 2 breastfeeding women taking fluvoxamine. The women (37 and 34 years old) and their infants (26 and 0.75 months old) were studied over a 24-hour dose interval at steady state. Fluvoxamine concentrations were measured by high-performance liquid chromatography. Infant exposure was measured as concentration in milk multiplied by an estimated milk production of 0.15 L/kg/d and normalized to the weight-adjusted maternal dose. M/P values of 1.34 and 1.21 were calculated for subjects 1 and 2, respectively, and relative infant doses were estimated to be 1.38% and 0.8%, respectively. No adverse effects in the infants were detected by the mother or on clinical examination, and fluvoxamine was not detected in the infants’ plasma (limit of detection 2 µ g/L). These limited data support the prescription of fluvoxamine to breastfeeding mothers after a careful, individual risk/benefit analysis is undertaken.

Key Words: fluvoxamine • human milk • milk/plasma ratio • relative infant dose

Journal of Human Lactation, Vol. 18, No. 2, 139-143 (2002)
DOI: 10.1177/089033440201800205
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