The Pediatric Trials Network (PTN) groundbreaking study, Pharmacokinetics and Safety of Commonly Used Drugs in Lactating Women and Breastfed Infants (CUDDLE), recently informed a Food and Drug Administration (FDA) label change for the drug oxycodone.

Historically, very few drug products have supporting data to indicate the effects on human breastmilk that is given to infants, making it unclear for new mothers if it is safe to continue taking certain medications while breastfeeding their children.

“Although the benefits of breastfeeding are well-documented, we still don’t know enough about the effects of many prescription and over-the-counter off-patent drugs when they are passed to infants through their mother’s breastmilk,” said Dr. Kevin Watt, Professor of Pediatrics at the University of Utah Health and CUDDLE Co-Investigator.

Astoundingly, only about 2% of drugs in the LactMed database, supported by the National Institutes of Health (NIH), have recommendations based on strong data. The work of PTN, and the CUDDLE study specifically, aims to remove the mystery from the decision-making process, allowing moms to breastfeed without this additional burden of uncertainty.

Mothers who participated in the CUDDLE study provided samples of breastmilk, their blood, their infants’ blood, or a combination to help researchers understand which drugs pass into breastmilk and determine the safest dose. 70 infants participating in the study were exposed to oxycodone through breastmilk and only 1.3% percent of a maternal dose of oxycodone was present in the breastmilk produced and given to infants. No adverse events attributed to oxycodone were reported, indicating it is safe for mothers to take oxycodone while breastfeeding.

This is the 21st FDA label change informed by PTN research, marking a substantial milestone for the Network. Thanks to the collaborative efforts of the studies, medical providers now have important, data-informed, information to indicate if is safe for breastfeeding mothers to take oxycodone while breastfeeding.

For more information about CUDDLE, access the study page on the PTN website.