Skip to content
DraconiticResearch
Search Sources API
186,631 studies31 sourcesUpdated 30 min ago
Peer-reviewedCC BY-NC-NDPharmacoepidemiology and drug safety

Safety of Multiple Sclerosis Treatments During Pregnancy: An Overview of the EU Regulatory Approach to Risk Management Planning

  • Valerie Strassmann1
  • Nathalie Gault2,3,4
  • Anette Kirstine Stark4,5
  • Tiphaine Vaillant4,6
  • Thomas Berbain6
  • Liana Martirosyan4,7
  • Viola Macolic Sarinic1
  • Hedvig Marie Egeland Nordeng4,8
8 affiliations
  1. 1European Medicines Agency, Amsterdam, the Netherlands.
  2. 2Académie de Santé Des Armées, Observatoire de la santé du Militaire et du vétéran, Ecole du Val-de-Grâce, Paris, France.
  3. 3Ministry of Health and Social Security, Directorate of Health, Division of Pharmacy and Medicines (DPM-DISA), Strassen, Luxembourg.
  4. 4Pharmacovigilance Risk Assessment Committee (PRAC), European Medicines Agency (EMA), Amsterdam, the Netherlands.
  5. 5Bispebjerg and Frederiksberg Hospital, Neurological Department, Copenhagen, Denmark.
  6. 6French National Agency for Medicines and Health Products Safety (ANSM), Saint-Denis, France.
  7. 7Medicines Evaluation Board, Utrecht, the Netherlands.
  8. 8Department of Child Health and Development, Norwegian Institute of Public Health, Oslo, Norway.
Read full textPDFDOICite

Abstract

Purpose

Multiple Sclerosis (MS) may affect women of childbearing age. Information on safety of disease modifying treatment (DMT) in pregnancy is often limited at time of marketing authorisation. We summarised the EU regulatory experience with the implementation and performance of additional pharmacovigilance activities concerning safety in pregnancy and breastfeeding for medicines to treat MS.Methods

We reviewed EU risk management plans (RMPs) for centrally authorised MS DMTs to identify additional pharmacovigilance activities related to pregnancy and breastfeeding. Information was analysed descriptively for type of measure, data collection method and data source. For non-interventional cohort studies and follow-up of reported pregnancy cases, information on current status, planned and actual size and duration was retrieved.Results

We identified 17 DMTs that included 21 additional pharmacovigilance activities related to pregnancy and breastfeeding across 15 RMPs. These comprised nine non-interventional cohort studies and four structured follow-up activities of pregnancy cases that had been started. Of those, three were terminated due to low recruitment with an inclusion rate slower than planned, while inclusion was faster than planned in three finalised activities. Inclusion rate was slowest in primary data collection and faster in secondary analyses and follow-up of reported pregnancy cases.Conclusion

Despite efforts to evaluate safety of MS medicines during pregnancy, recruitment and data collection remain challenging. Planning for use of multiple real-world data sources-including primary data collection, secondary use of electronic health records, and analyses of case reports-may help overcome these challenges and strengthen MS drug safety evaluations in pregnancy.

Related

  1. Hypertension in People with Multiple Sclerosis: Epidemiology, Mechanisms, Hypertensive Disorders of Pregnancy, and Clinical Implications.
    Ahmed Arafa, Amira S A Said, Ehab Elkady +3
    Diseases (Basel, Switzerland)Peer-reviewedCC BYFull textGeneral medicineEurope PMC
  2. Association Between Disability and Longitudinal Brain Volumetric Measures Across the Peri-Pregnancy Period in Women with Multiple Sclerosis: A Pilot Study
    M. T. Sonmez, S. Koc, K. Buyukturkoglu +4
    medRxivPreprintCC BY-NC-NDFull textNeurologymedRxiv
  3. Disease Activity During Pregnancy and Postpartum in Women With Multiple Sclerosis Treated With Ocrelizumab or Rituximab Before Pregnancy.
    Nadine Bast, Karen Dost-Kovalsky, Sabrina Haben +4
    Neurology(R) neuroimmunology & neuroinflammationPeer-reviewedCC BY-NC-NDFull textGeneral medicineEurope PMC
  4. Maternal body mass index in early pregnancy and offspring risk of multiple sclerosis: A population-based cohort study
    H. Xu, N. Razaz, K. Remaeus +3
    medRxivPreprintCC BY-NC-NDFull textNeurologymedRxiv
  5. A qualitative study of care management challenges in patients with multiple sclerosis from patient, family caregiver and healthcare provider perspectives
    Somayeh Azimpour, Nasrollah Alimohammadi, Fatemeh Nazari +1
    Scientific ReportsPeer-reviewedCC BY 4.0Full textGeneral medicineCrossref

Cite

BibTeXRIS
BibTeX
@article{strassmann2026safety,
  title = {{Safety of Multiple Sclerosis Treatments During Pregnancy: An Overview of the EU Regulatory Approach to Risk Management Planning}},
  author = {Valerie Strassmann and Nathalie Gault and Anette Kirstine Stark and Tiphaine Vaillant and Thomas Berbain and Liana Martirosyan and Viola Macolic Sarinic and Hedvig Marie Egeland Nordeng},
  journal = {Pharmacoepidemiology and drug safety},
  year = {2026},
  month = oct,
  doi = {10.1002/pds.70506},
  url = {https://europepmc.org/article/PMC/PMC13719238},
  note = {CC BY-NC-ND},
}
RIS
TY  - JOUR
TI  - Safety of Multiple Sclerosis Treatments During Pregnancy: An Overview of the EU Regulatory Approach to Risk Management Planning
AU  - Valerie Strassmann
AU  - Nathalie Gault
AU  - Anette Kirstine Stark
AU  - Tiphaine Vaillant
AU  - Thomas Berbain
AU  - Liana Martirosyan
AU  - Viola Macolic Sarinic
AU  - Hedvig Marie Egeland Nordeng
PY  - 2026
DA  - 2026/10/29
JO  - Pharmacoepidemiology and drug safety
DO  - 10.1002/pds.70506
UR  - https://europepmc.org/article/PMC/PMC13719238
AB  - Purpose  Multiple Sclerosis (MS) may affect women of childbearing age. Information on safety of disease modifying treatment (DMT) in pregnancy is often limited at time of marketing authorisation. We summarised the EU regulatory experience with the implementation and performance of additional pharmacovigilance activities concerning safety in pregnancy and breastfeeding for medicines to treat MS.Methods  We reviewed EU risk management plans (RMPs) for centrally authorised MS DMTs to identify additional pharmacovigilance activities related to pregnancy and breastfeeding. Information was analysed descriptively for type of measure, data collection method and data source. For non-interventional cohort studies and follow-up of reported pregnancy cases, information on current status, planned and actual size and duration was retrieved.Results  We identified 17 DMTs that included 21 additional pharmacovigilance activities related to pregnancy and breastfeeding across 15 RMPs. These comprised nine non-interventional cohort studies and four structured follow-up activities of pregnancy cases that had been started. Of those, three were terminated due to low recruitment with an inclusion rate slower than planned, while inclusion was faster than planned in three finalised activities. Inclusion rate was slowest in primary data collection and faster in secondary analyses and follow-up of reported pregnancy cases.Conclusion  Despite efforts to evaluate safety of MS medicines during pregnancy, recruitment and data collection remain challenging. Planning for use of multiple real-world data sources-including primary data collection, secondary use of electronic health records, and analyses of case reports-may help overcome these challenges and strengthen MS drug safety evaluations in pregnancy.
SN  - 1053-8569
SN  - 1099-1557
ER  -