Researchers have developed a new, rigorous method for studying how medicines affect breastfeeding mothers and their infants. This comes amid concerns that many women stop important treatments during pregnancy and breastfeeding due to unknown risks.
Currently, 95% of medicines lack sufficient safety data for use during pregnancy and breastfeeding.
Existing studies mostly rely on animal data or outdated methods that estimate drug transfer to infants based on milk concentrations alone. These studies also involve very few participants.
A new protocol published in BMJ Open aims to change this. It involves collecting and analyzing breast milk and blood plasma samples from both mothers and their breastfed babies.
The focus is on drugs like prednisolone, used to treat Rheumatoid Arthritis, and metformin, prescribed for type 2 Diabetes. These samples are stored in biobanks for future research, allowing long-term study of medication effects on infants.
Women participating in the study are recruited through clinical centers in Sweden. The samples are managed by a European network of breast milk biobanks, ensuring broad collaboration and future research possibilities. Mats G. Hansson, a lead researcher, highlights that this integration into a larger European framework strengthens the study’s impact.
This protocol was developed under the European ConcePTION project, which aims to improve drug safety knowledge for pregnant and breastfeeding women. It sets a new gold standard for clinical lactation research by combining advanced pharmacokinetic analysis with ethical biobanking and informed consent.
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