# Communicating medication risks in pregnancy: Towards shared decision making

Ursula Winterfeld, Kenneth Hodson, Maya Berlin, Benoît Marin, Michael Ceulemans, Corinna Weber-Schoendorfer, François R Girardin, David Baud, Béatrice Schaad, Alice Panchaud

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Ursula Winterfeld, Kenneth Hodson, Maya Berlin, Benoît Marin, Michael Ceulemans, et al. Communicating medication risks in pregnancy: Towards shared decision making. Frontiers in Drug Safety and Regulation, 2025, 5, pp.1712216. 10.3389/fdsfr.2025.1712216. hal-05362810

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EDITED BY
Wolfgang Paulus,
University of Ulm, Germany

REVIEWED BY
Herbert Juch,
Medical University of Graz, Austria

*CORRESPONDENCE
Ursula Winterfeld,
ursula.winterfeld@chuv.ch

RECEIVED 24 September 2025

ACCEPTED 06 October 2025

PUBLISHED 16 October 2025

CORRECTED 22 October 2025

CITATION

Winterfeld U, Hodson K, Berlin M, Marin B, Ceulemans M, Weber-Schoendorfer C, Girardin FR, Baud D, Schaad B and Panchaud A (2025) Communicating medication risks in pregnancy: Towards shared decision making. *Front. Drug Saf. Regul.* 5:1712216.
doi: 10.3389/fdsfr.2025.1712216

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© 2025 Winterfeld, Hodson, Berlin, Marin, Ceulemans, Weber-Schoendorfer, Girardin, Baud, Schaad and Panchaud. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) and the copyright owner(s) are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.

# Communicating medication risks in pregnancy: Towards shared decision making

Ursula Winterfeld¹*, Kenneth Hodson²,³, Maya Berlin⁴,
Benoît Marin⁵, Michael Ceulemans⁶,⁷,⁸,
Corinna Weber-Schoendorfer⁹, François R. Girardin¹⁰,
David Baud¹¹, Béatrice Schaad¹²,¹³ and Alice Panchaud¹⁴,¹⁵

¹Swiss Teratogen Information Service and Clinical Pharmacology Service, Lausanne University Hospital, Lausanne, Switzerland, ²UK Teratology Information Service, Newcastle upon Tyne, United Kingdom, ³Directorate of Women's Services, Royal Victoria Infirmary, Newcastle upon Tyne, United Kingdom, ⁴Clinical Pharmacology and Toxicology Unit, Drug Consultation Center, Shamir Medical Center affiliated with Faculty of Medical & Health Science, Tel Aviv University, Tel Aviv, Israel, ⁵Département de Santé Publique, Sorbonne Université, INSERM, Institut Pierre Louis d'Epidémiologie et de Santé Publique, AP-HP, Hôpital Trousseau, Centre de Référence sur les Agents Tératogènes (CRAT), Paris, France, ⁶Department of Pharmaceutical and Pharmacological Sciences, Leuven, Belgium, ⁷KU Leuven Child & Youth Institute, Leuven, Belgium, ⁸IQ Health, Radboud University Medical Center, Nijmegen, Netherlands, ⁹Charité – Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Pharmakovigilanzentrum Embryonaltoxikologie, Institut für Klinische Pharmakologie und Toxikologie, Berlin, Germany, ¹⁰Service of Clinical Pharmacology, Department of Medicine, Lausanne University Hospital and University of Lausanne, Lausanne, Switzerland, ¹¹Materno-Fetal and Obstetrics Research Unit, Department "Woman-Mother-Child", Lausanne University Hospital, Lausanne, Switzerland, ¹²Communication Department, Lausanne University Hospital, Lausanne, Switzerland, ¹³Institute of Humanities in Medicine, Lausanne University Hospital and University of Lausanne, Lausanne, Switzerland, ¹⁴Service of Pharmacy, Lausanne University Hospital and University of Lausanne, Lausanne, Switzerland, ¹⁵Institute of Primary Healthcare (BIHAM), University of Bern, Bern, Switzerland

Medication use during pregnancy is common, yet safety data remain limited, often leading to exaggerated risk perceptions and suboptimal care. Current communication practices are fragmented: product labeling and patient leaflets tend to emphasize potential harms, while specialized resources are underused. We explore the challenges of conveying accurate risk-benefit information and highlight the need for shared decision making. Integrated, evidence-based resources accessible to both healthcare providers and patients can reduce misinformation, improve adherence to essential treatments, and ultimately enhance maternal and child health. The Swiss MAMA-MEDS initiative illustrates how a unified knowledge base can align messaging, address health inequalities, and support patient-centered pregnancy care.

KEYWORDS

medication, pregnancy, risk communication, shared decision making, pharmacovigilance

## 1 Introduction

In 1961, thalidomide as an unforeseen human teratogenic drug led to the exclusion of most women of childbearing potential and pregnant women from clinical trials (Gerbier and Panchaud, 2023). Consequently, our knowledge about drug safety in pregnancy is reliant on observational data collected post-marketing, with a significant time lag between a drug's initial approval and the availability of essential pharmacokinetic and safety data specific to pregnancy (Gerbier and Panchaud, 2023). The result is highly restrictive drug labelling, often limited to "do not use during pregnancy" or "use with caution during
pregnancy” recommendations. Extensive and supportive knowledge
about a drug is rarely incorporated into product labelling, whereas
study findings linking drugs to malformations are quickly included
in package leaflets (Winterfeld et al., 2014; Crettenand et al., 2018).
As patients frequently refer to the package leaflet, while healthcare
providers (HCP) predominantly rely on the summary of product
characteristics (SmPC), this perpetuates the misconception that all
drugs are dangerous during pregnancy (Csajka et al., 2014; Sanz
et al., 2001). The result is a widespread distortion of the safety
information used by HCP to communicate with their patients.

## 2 Challenges in communicating medication risks during pregnancy

While many medications have not been shown to adversely
affect fetal health, certain conditions such as systemic lupus
erythematosus, diabetes, or inflammatory bowel disease
necessitate careful management during pregnancy.
Discontinuing medication may lead to maternal health
decline, posing greater risks to the fetus than the potential
hazards associated with the medication itself. Thus, optimal
disease management during pregnancy is essential for the
wellbeing of both mother and child. Medication use is highly
prevalent with 27%-93% of women reporting using at least one
drug during pregnancy with variations across countries
(Mitchell et al., 2011; Lupattelli et al., 2014; Daw et al., 2011).
These figures are expected to rise due to higher maternal age at
first pregnancy (EUROSTAT, 2021), associated with an
increased risk of pre-existing medical conditions and
pregnancy complications, and frequent polypharmacy
(Fridman et al., 2014; Anand et al., 2023).

The decision to use medication during pregnancy should
consider safety data availability, treatment indication, maternal
disease severity, and alternative options. In reality, risk
perception by both women and HCP are crucial, with studies
indicating overestimation of medication-induced malformation
risk by both groups (Sanz et al., 2001; Ceulemans et al., 2019).
Thus, even when a medication is not expected to adversely affect the
health of the fetus, mothers might receive incorrect advice to
discontinue essential treatments. This miscommunication poses a
serious risk, potentially harming both the mother and child, and, in
extreme cases, end in unjustified termination of pregnancy (Schirm
et al., 2004; Saha et al., 2015; Einarson et al., 2001a; Polifka and
Friedman, 2003; Einarson et al., 2001b). Moreover, regardless of the
advice of the HCP, women may choose to discontinue essential
medications due to safety concerns or uncertainty about potential
adverse effects on the fetus (Watanabe et al., 2021). The overly
cautious attitude towards the use of medication during pregnancy is
a major issue in communicating medicine, particularly in the field of
maternal health and obstetrics. Although the direct impact of
communicating distorted information remains relatively
unexplored, some evidence of pregnancy disruptive effects has
been provided for chronic conditions, such as hypertension,
lupus, psychiatric disorders, epilepsy, or inflammatory bowel
disease, with observed increase of risk of relapse, hospital
admission, and disability in case of avoidance of medication use
(Einarson et al., 2001a; Cohen et al., 2004; Cohen et al., 2006;

Alcantarilla et al., 2023; Benard-Laribiere et al., 2020; Edey et al.,
2014; Leach et al., 2017; Hellwig et al., 2022).

## 3 Role and limitations of current information sources

Whilst there is still insufficient evidence regarding the safety of
medicines during pregnancy, where evidence does exist, it should be
communicated and factored into the risk assessment. Experts in this
domain gather and disseminate this information through specialized
up-to-date sources (Table 1). These resources provide
comprehensive data, risk classification, therapeutic alternatives,
and practical guidance for pregnancy follow-up. In addition to
reference books, websites, such as UKTIS (www.uktis.org),
Embryotox (in German) (Embryotox, 2018), and Le CRAT (in
French) (CRAT, 2018; Elefant et al., 2014), serve as reliable
online sources for HCP and are accessible for everyone free of
charge. BUMPs (www.medicinesinpregnancy.org) and
MotherToBaby (in English) are directed towards parents,
addressing the need for accessible information. HCP, and
sometimes patients, can also obtain information and individual
risk assessments from Teratology Information Services (TIS)
(Chambers, 2011). These centers of expertise provide free
information and advice, prospectively collect high quality data on
reported cases of exposure and outcomes, and pool these data at a
network level (e.g., MotherToBaby, European Network of
Teratology Information Services-ENTIS (European Network of
Teratology Information, 2011)) to improve knowledge on drug
safety during pregnancy (Lurie et al., 2021). Despite the
availability of various resources, there is currently no specialized
information source tailored to address the information needs of both
HCP and patients simultaneously.

## 4 Discussion

Although currently lacking, a single data source for HCPs and
patients, would promote shared decision-making by encouraging
information synergy. Shared decision-making is a collaborative
process between patients and their HCP, aimed at reaching joint
decisions and broad consensus about care based on evidence and
informed personal preferences, health beliefs, and values (NICE,
2018; NICE, 2015). This involves ensuring that patients have a
good understanding of the risks, benefits, and possible
consequences of different options through discussion and
information sharing (Stacey et al., 2024). While the benefits of
shared-decision making are increasingly recognized, it is not yet
routinely practiced in every setting, particularly within the
specific field of medication use during pregnancy. A common
information tool for patient and HCP aligns with key steps
recommended in shared decision-making implementation
frameworks (England, 2022). Providing access to evidence-
based, language appropriate information for patients and
HCPs empowers individuals to make informed decisions and
promotes adherence to evidence-based treatment. A common
data source serves as a decision support tool tailored to
individuals with varying levels of health literacy, facilitating
<table><caption>TABLE 1 Information sources for medication use during pregnancy.</caption><thead><tr><th>Name of source</th><th>Description</th><th>Hosting country</th><th>Target audience</th><th>Reference</th></tr></thead><tbody><tr><td colspan="5">Online Databases</td></tr><tr><td>Le CRAT</td><td>Information on medication use and medication risks during pregnancy, breastfeeding as well as in case of paternal exposure</td><td>France</td><td>HCPs</td><td>Centre de Référence sur les Agents Tératogènes (CRAT). <a href="http://www.lecrat.fr">http://www.lecrat.fr</a></td></tr><tr><td>Embryotox</td><td>Information on medication use during pregnancy and breastfeeding</td><td>Germany</td><td>HCPs</td><td>Embryotox. <a href="https://www.embryotox.de/">https://www.embryotox.de/</a></td></tr><tr><td>Netherlands Pharmacovigilance Centre Lareb</td><td>Medication safety information during pregnancy and breastfeeding</td><td>Netherlands</td><td>HCPs</td><td><a href="https://www.lareb.nl/mvm-kennis-zoeken?zoekterm=paracetamol%2Fcodeine&zwangerschap=true&amp;borstvoeding=true">https://www.lareb.nl/mvm-kennis-zoeken?zoekterm=paracetamol%2Fcodeine&zwangerschap=true&amp;borstvoeding=true</a></td></tr><tr><td>Janusmed</td><td>National knowledge database on medication effects during pregnancy and breastfeeding</td><td>Sweden</td><td>HCPs</td><td><a href="https://janusmed.se/fosterpaverkan">https://janusmed.se/fosterpaverkan</a></td></tr><tr><td>UKTIS Monographs</td><td>Information on the safety of medications during pregnancy</td><td>United Kingdom</td><td>HCPs</td><td><a href="https://uktis.org/monographs/">https://uktis.org/monographs/</a></td></tr><tr><td>Best Use of Medicines in Pregnancy (BUMPs)</td><td>Patient information leaflets on medication use during pregnancy</td><td>United Kingdom</td><td>Patients</td><td>bumps - best use of medicine in pregnancy (medicinesinpregnancy.org)</td></tr><tr><td>MotherToBaby</td><td>Fact sheets on medications and pregnancy</td><td>United States</td><td>Patients</td><td><a href="https://mothertobaby.org/fact-sheets/">https://mothertobaby.org/fact-sheets/</a></td></tr><tr><td>Reprotox®</td><td>Online database on environmental hazards to human reproduction and development</td><td>United States</td><td>HCPs</td><td>REPROTOX® Reproductive Hazard Information. <a href="https://reprotox.org/">https://reprotox.org/</a></td></tr><tr><td>Shepard's Catalog of Teratogenic Agents</td><td>Information on teratogenic agents including chemicals, food additives, household products, environmental pollutants, pharmaceuticals, and viruses</td><td>United States</td><td>HCPs</td><td><a href="https://www.micromedexsolutions.com/">https://www.micromedexsolutions.com/</a></td></tr><tr><td>TERIS Teratogen Information System</td><td>Information on the teratogenic effects of drugs and environmental agents</td><td>United States</td><td>HCPs</td><td><a href="https://deohs.washington.edu/teris/">https://deohs.washington.edu/teris/</a></td></tr><tr><td>IMI ConcePTION Knowledge Bank</td><td>Additional resource of information under development</td><td></td><td>HCPs and patients</td><td><a href="https://www.imi-conception.eu/">https://www.imi-conception.eu/</a><br>F. O'Shaughnessy, B. Cuppers, U. Norby, M. Berlin, P. D. Skold, J. L Richardson. Neurotoxicology and Teratology, 92 (2022):107,108</td></tr><tr><td colspan="5">Reference Books</td></tr><tr><td>Briggs Drugs in Pregnancy and Lactation</td><td>Reference guide to fetal and neonatal risk</td><td>United States</td><td>HCPs</td><td>Briggs GG, Forinash AB, Towers CV. Briggs Drugs in Pregnancy and Lactation: A Reference Guide to Fetal and Neonatal Risk. Lippincott Williams and Wilkins; 2021</td></tr></tbody></table>

HCPs: healthcare professionals.

comprehension of available options and associated benefits, harms, consequences, and burdens. It also helps HCPs and patients to make high-value decisions, such as in pregnancy, where decisions about the use of medicines can have a significant impact on the health of both mother and child. Furthermore, a common data source can serve as a training tool for HCPs, specifically in the context of risk communication, facilitating meaningful shared decision-making conversations. Health informatics must also work to address health inequality that exists within most high-income countries. In the UK, for example, compared to white women, there was a more than three-fold increase in maternal mortality in women from black ethnic backgrounds, and mortality was almost doubled in women from Asian ethnic backgrounds. Furthermore, babies born to these women were more likely to be stillborn, or to die in the neonatal period (MBRRACE-UK, 2022). Communication failures including language barriers, and inadequate information or signposting are common themes cited by

women from these communities (Khan et al., 2023). Due to socioeconomic factors, these women have more complex medical needs and so the need to deliver accessible information about medicine use and healthcare in general is imperative.

Addressing gaps in medication risk communication during pregnancy requires resources that are reliable, accessible, and tailored to both healthcare providers and patients. Such tools can strengthen shared decision making, promote informed choices, and improve maternal and child health outcomes. Initiatives like MAMA-MEDS in Switzerland illustrate how these approaches can be put into practice.

## Data availability statement

The raw data supporting the conclusions of this article will be made available by the authors, without undue reservation.
## Author contributions

UW: Conceptualization, Writing – original draft, Writing – review and editing. KH: Writing – review and editing. MB: Writing – review and editing. BM: Writing – review and editing. MC: Writing – review and editing. CW-S: Writing – review and editing. FG: Writing – review and editing. DB: Writing – review and editing. BS: Writing – review and editing. AP: Conceptualization, Writing – original draft, Writing – review and editing.

## Funding

The author(s) declare that financial support was received for the research and/or publication of this article. The research activities of MC are supported by a Senior Postdoctoral Fellowship of the Research Foundation Flanders (FWO, 1246425N).

## Conflict of interest

The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.

The author(s) declared that they were an editorial board member of Frontiers, at the time of submission. This had no impact on the peer review process and the final decision.

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## Correction Note

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