More than 5 million women become pregnant in the EU every year and a majority take at least one medication during pregnancy. A problem today is that as few as 5% of available medications have been adequately monitored, tested and labelled with safety information for use in pregnant and breastfeeding women. The field is difficult to study and has suffered from a lack of systematically gathered insights that could lead to more effective data generation methodologies. Fragmentation and misinformation results in confusing and contradictory communication and perception of risks by both health professionals and women and their families. For the doctor who prescribes the medicine, a genuine moral dilemma arises. In order not to expose the child to risks, the lack of good scientific evidence in many cases means that, for precautionary reasons, the drug treatment is discontinued or the mother is advised not to breastfeed. At the same time, the mother benefits most from the prescribed medicine and we know that breastfeeding is good for both the newborn and the mother.
Within the project ConcePTION, several studies are underway to investigate the effect of drugs both during pregnancy and during breastfeeding. Based on the need to meet regulatory requirements, procedures have been established for breast milk collection, informed consent, shipping, storage and analysis of pharmacokinetic properties (how drugs are metabolized in the body). Five demonstration studies are conducted. The University of Oslo is doing such a study on a drug called Levocetirizine, the University Hospital of Toulouse is studying Amoxicillin and the University Hospital of Lausanne is studying the drug Venlafaxine.
In Sweden, in two demonstration studies, we will collect breast milk and blood samples from the mother and the child for two drugs: metformin, which is used in the treatment of type 2 diabetes and prednisolone, which is used in the treatment of for example rheumatoid arthritis. In both cases, there is limited data, which is partly old, from the 1970s, and partly analyzed with outdated methods. Both studies are approved by The Swedish Medical Product Authority (MPA) as low intervention clinical trials (see below).
The studies are a collaboration between Uppsala University and several clinical centers: Sahlgrenska University Hospital/East in Gothenburg, Örebro University Hospital, Center for Clinical Children’s Studies, Astrid Lindgren Children’s Hospital in Stockholm, Södra Älvsborgs Hospital in Borås and Umeå University Hospital, with adjacent biobanks. Breast milk from the woman and blood samples from both woman and child will be transported to Uppsala Biobank for storage and analyzed with mass spectrometric methods at the Department of Pharmacy at Uppsala University. Informed consent is obtained both for the sampling and for the possibility of conducting future research on the stored samples. Collaborating biobanks are: Uppsala Biobank, Biobank West in Gothenburg, Örebro Biobank, Stockholm Medical Biobank and Biobank North in Umeå.
Through these two studies, research biobanks with breast milk and associated blood samples are established for the first time in Sweden. In the long run, doctors and women who become pregnant can get better information for their recommendations and decisions regarding the use of medicines.
ConcePTION is funded by the Innovative Medicines Initiative (IMI), which is a collaboration between the European Commission and the European Medicines Federation.
Approvals by the Swedish Medical Product Authority (MPA): Dnr: 5.1.1-2023-090592 and 5.1.1-2023-104170.
Written by…
Mats G. Hansson, senior professor of biomedical ethics at Uppsala University’s Centre for Research Ethics & Bioethics.
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