Finding information about medicine safety in pregnancy and breastfeeding is challenging. But the problem extends beyond a mere lack of data. A recent ConcePTION publication reveals that the recommendations for how a drug should be taken by pregnant and breastfeeding women vary a lot between different information sources. Even between the most credible sources and in both information intended for patients and health care professionals. The authors also identify a critical need to harmonise information within and between countries.

We need more and better follow-up of data describing if a particular medicine is safe to use during pregnancy and breastfeeding. This knowledge gap often leads to women receiving suboptimal treatment, or no treatment at all. Sometimes it puts the baby at risk, and mothers might choose not to breastfeed, or stop earlier than they would like. The safety data that is available is often contradictory, scattered, and inconsistent.

ConcePTION researchers have analysed available information about the safety of medicines during pregnancy and breastfeeding. They have looked at six particular drugs in online resources for patients and health care professionals, in four different EU languages. The results show that more than half of the comparisons of pregnancy safety information had discrepant recommendations. For breastfeeding, only 17 % of the comparisons between information written for patients were consistent. The researchers also found that recommendations from specialised teratology information services in the different languages were generally in agreement. And that information for health care professionals was slightly more consistent between sources.

The ConcePTION project will bridge the knowledge gap of medicine safety in pregnancy and breastfeeding, and one result of our efforts will be a European information resource for both women and health care professionals. This knowledge bank will allow users to access information that is both harmonised, evidence-based, and up to date.

One of the authors of the paper is Ulrika Nörby, a pharmacist at the Medical Health and Care Administration in Region Stockholm, Sweden. According to her, when women cannot find the information they need, they should turn to the health care system for answers. But when the health care professionals can’t find clear answers either, there is nothing to base the decisions that need to be taken on.

“ConcePTION is trying to solve this problem, by building the infrastructures needed to increase the knowledge and provide a place where laypeople and health care professionals can go to receive the same information, based on well-grounded and updated sources produced by experts. To avoid misunderstanding and to simplify for all,” says Ulrika Nörby.

By Anna Holm

Nörby U, Noël-Cuppers B, Hristoskova S, et al. Online information discrepancies regarding safety of medicine use during pregnancy and lactation: an IMI ConcePTION study, Expert Opinion on Drug Safety (2021), First online 8 June 2021

Breastfeeding brings many positive effects on the health and wellbeing of both mother and child. But breastfeeding mothers get sick like the rest of us, which means they also need medicines. We believe that each woman should have the right to make decisions about breastfeeding based on information she can trust. We are providing one step in that direction, developing a model for how medicines transfer to milk!

Studying how different substances transfer to milk is difficult and complex, and until now there has been almost no information how safe it is to use a particular drug while breastfeeding. This means that women often have to choose between breastfeeding and treatments they need. ConcePTION is collecting and analyzing milk samples from women who use medicines while breastfeeding. But that kind of study is not always possible, and in some cases not a risk we want to take. For the times we can’t test milk, we need a non-clinical platform that combines methods that helps predict the safety profile of a particular drug.

One of the teams in ConcePTION, work package 3, is using a combination of in vitro (cell lines), in vivo (animal models) and in silico models that will allow fast and reliable predictions on how a substance transfers to human breast milk. Want to know more about how it works? Nina Nauwelarts (PhD student) and Kelly Janssens (lactation consultant) from UZ Leuven, Neonatology, explains how it works! The video has subtitles in English, Spanish and Dutch.

Nina Nauwelarts is one of the authors of a comprehensive review of the non-clinical methods that can be used to study how a medicine transfers to breast milk.

Nauwelaerts N, Deferm N, Smits A et al. A comprehensive review on non-clinical methods to study transfer of medication into breast milk – A contribution from the ConcePTION project. Biomedicine & Pharmacotherapy, volume 136, article 111038, April 2021.

We have also published a review on animal models for in-vivo lactation studies.

Ventrella D, Ashkenazi N, Elmi A et al. Animal Models for In Vivo Lactation Studies: Anatomy, Physiology and Milk Compositions in the Most Used Non-Clinical Species: A Contribution from the ConcePTION Project. Animals, volume 11 (no 3), 714 (2021).

More publications from ConcePTION: https://www.imi-conception.eu/papers/

By Josepine Fernow

The French health authority ANSM is launching a study to assess the safety of Covid-19 vaccines in pregnancy. The Covacpreg study is part of the enhanced vaccine surveillance system set up by the ANSM and the regional pharmacovigilance centers (CRPV), who are responsible for monitoring the adverse effects of Covid-19 vaccines. The  Covapreg study will follow the course of post-vaccination pregnancies until the birth of the child. With the aim to enrich scientific knowledge on the Covid-19 vaccines in pregnancy.

Starting 3 April this year, pregnant women in France (from the 2nd trimester) have been given priority for access to vaccination with an mRNA vaccine (Comirnaty from Pfizer BioNtech and Moderna laboratories), in particular if they present with risk pathology or if they are susceptible to be in contact with infected people in their professional capacity.

Although studies to date have not shown any adverse consequences for the course of pregnancy from Covid-19 vaccines, the data needs to be consolidated. This is why the information collected during this study will be of great help in increasing knowledge about Covid-19 vaccines and their possible adverse effects in pregnant women. Participation in this study of pregnant women vaccinated against Covid-19 is on a voluntary basis and does not modify the medical monitoring of their pregnancy.

How will the study proceed?

After registration, participants will be contacted by phone or email, by the clinical research associate (ARC) of the CRPV in Lyon or Toulouse in order to answer a questionnaire (approximately 15 minutes in duration): approximately 1 month after the date of vaccination (after the 1st dose and/or after the 2nd dose): to determine the medical history, any medication taken, previous pregnancies, any adverse effects after vaccination, etc. Note: Women vaccinated at the start of pregnancy will also be asked to answer a questionnaire after the 2nd trimester ultrasound. After the due date: to know the progress of the pregnancy and their newborn.

There’s more information on the site, but I hope that what I have provided constitutes a helpful summary.

ANSM stands for L’Agence nationale de sécurité du médicament et des produits de santé (The National Agency for the Safety of Medicines and Health Products).

By David Lewis, Novartis