New Clinical Trials Set Gold Standard for Breastfeeding and Medication Safety: BMJ Study
BMJ Open has published a protocol that sets a new gold standard for clinical lactation studies, addressing the ethical and scientific gaps in understanding drug safety during pregnancy and breastfeeding. The protocol is part of two ongoing clinical trials at Uppsala University’s Centre for Research Ethics & Bioethics.
Women who stop treatment during pregnancy or breastfeeding face a troubling dilemma, as they must weigh their desire to have children and breastfeed against poorly understood health risks.
Currently, 95% of all medicines lack sufficient safety data for use during pregnancy and lactation. Existing standards rely heavily on outdated animal studies and limited data, using pharmacokinetic/pharmacodynamic (PB/PK) models to estimate drug transfer to infants. The new protocol goes further by collecting and analyzing breast milk and plasma samples from both mothers and breastfed infants.
The trials focus on two commonly prescribed medications: prednisolone, used for rheumatoid arthritis, and metformin, used for type 2 diabetes. Samples are biobanked and analyzed for pharmacokinetics and drug transfer levels, with informed consent enabling future research and long-term follow-up on medication effects in infants.
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