Understanding how medicines transfer from a mother to the breastfeeding infant is crucial for women who need to take informed decisions about medical treatment. Right now, we are launching two clinical studies to collect breast milk and blood samples from mothers and infants, to study how two commonly used medicines transfer through milk. This study paves the way for evidence-based recommendations for treating diabetes, rheumatoid arthritis and other diseases during breastfeeding.
To avoid exposing a child to risks, women are often advised not to breastfeed. At the same time, we know that breastfeeding is good for both mother and child.
Metformin, prescribed for Type 2 Diabetes, and prednisolone, used to treat rheumatoid arthritis, can help manage chronic illness. However, the data in relation to breastfeeding is over 40 years old. And based on outdated methods. The Innovative Medicines Initiative-funded ConcePTION project is making an important contribution to our understanding of medicine safety in breastfeeding. The new studies follow in the footsteps of ConcePTION partners at the University of Oslo, the University Hospital of Toulouse and the University Hospital of Lausanne, that have conducted other lactation studies on different medicines.
What makes the Swedish study unique is the analysis of blood from infants, allowing researchers to determine, not just estimate, how these drugs transfer from mother to child, according to Mats Hansson, Senior Professor of Biomedical Ethics and Uppsala University. But adding this step to a lactation study also complicates things. It has turned what would normally be considered research studies into formal clinical trials. Both studies have been approved by The Swedish Medical Product Agency as low-intervention clinical trials, with informed consent obtained both for the sampling and the possibility of conducting future research on the stored samples.
Making this happen requires close collaboration with clinical centres and national biobanks. The studies are part of a large biobanking effort, with samples stored as part of the European Breast Milk Collection: a cornerstone of these efforts to advance medicine safety for breastfeeding mothers and infants.
As part of a broader initiative, the Swedish endeavour represents a coordinated effort towards establishing a comprehensive research infrastructure for collecting, storing and analysing breast milk samples. This structure will support the bridging of knowledge gaps in lactation studies.
As a self-sustaining platform, the Breast Milk Collection not only supports current research endeavours but also promises to pave the way for future advancements in evidence-based healthcare – benefiting both mothers and infants, says Mats Hansson.
By Anna Holm Bodin