Demography in Pharmacokinetics and Safety of Commonly Used Drugs in Lactating Women and Breastfed Infants - Oxycodone

Participant Demographic Information
Study Description
This master protocol included multiple drugs of interest (DOIs) being studied. The primary objective of this study was to evaluate the pharmacokinetics of commonly used drugs in the blood and breastmilk of lactating women and in the blood of breastfed infants. The secondary objective was to describe the safety profile of commonly used drugs in infants exposed to drugs in breastmilk. This clinical study report presents data for the DOI oxycodone.

Oxycodone plasma and breastmilk samples were collected from lactating women and their infants (≤180 days of age) enrolled in this study. The concentrations of oxycodone and each of its metabolites in maternal plasma and breastmilk were summarized by 3-hour time windows over 24 hours. Results indicate that oxycodone and its metabolites are concentrated in human breastmilk. Based on the concentration and safety data, oxycodone administered to breastfeeding mothers at doses <60 mg/day is unlikely to result in clinically relevant exposures of adverse outcomes in breastmilk fed infants. The safety population included enrolled mothers (N=77) and infants (N=73).