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Medication Safety in Pregnancy

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March 2024

EUROmediCAT Annual Meeting 2024


29 representatives from 14 European registries recently gathered in London for a very successful two-day symposium in St George’s, University of London – the first EUROmediCAT face-to-face meeting since Covid!


With many registries involved in the IMI ConcePTION project, demonstration projects and tasks were discussed in addition to EUROmediCAT projects, collaborations and future planning. 


Hospitality from Joan and her team at St George’s was very much appreciated by everyone and many delegates enjoyed a celebratory networking dinner at a popular London restaurant.


Thank you to everyone who was able to attend and those who could not were greatly missed.


January 2024

JUST PUBLISHED - Drug utilisation studies are used to explore the medical, social and economic effects of the marketing, distribution, prescription and use of a medicine in society. Unlike clinical trials, these studies are performed after a treatment has already been brought to market. In the case of medicine safety in pregnancy and breastfeeding, drug utilisation studies play an important role in filling the knowledge gap, providing a firm foundation for safety studies by contextualising spontaneous reporting of serious adverse events by Lopez-Leon, S., Geldhof, A., Scotto, J., Wurst, K., Sabidó, M., Mo, J., et al.  Read the article here.




January 2023

JUST PUBLISHED - A population-based matched cohort study of major congenital anomalies following COVID-19 vaccination and SARS-CoV-2 infection by Clara Calvert, Jade Carruthers, Cheryl Denny, Jack Donagy, Lida E M Hopcroft, Leanne Hopkins et al.  Read the article here.


December 2022

JUST PUBLISHED: Families need support to reduce the risk of adverse drug reactions from breastfeeding by Sue Jordan, Emyr Jones, Sophia Komninou, Maria Loane & Christine Damase-Michel in Pharmaceutical Journal.  Read the article here.


August 2022

Women who take prescription medicines during pregnancy and breastfeeding often ask if medicines will make breastfeeding more difficult, and if medicines in breastmilk will affect their babies. As part of the  ConcePTION project, we have just published a call for population databases to link data on three factors: medicine exposure; breastfeeding and infant development. This will allow the long-term impacts of medicines taken by women during pregnancy and when breastfeeding to be better understood.

Read our new publication by clicking the following link Breastfeeding, pregnancy, medicines, neurodevelopment, and population or in International Breastfeeding Journal volume 17. 


March 2022

New Publication:

COVID‐19 in pregnancy—what study designs can we use to assess the risk of congenital anomalies in relation to COVID‐19 disease, treatment and vaccination? - Dolk - - Paediatric and Perinatal Epidemiology - Wiley Online Library


Jan 2022

Our group is very pleased to contribute to the influential ENCePP guide on research methods. Our SAIL work on congenital anomalies is cited as an illustration of comprehensive identification of adverse drug reactions and confounders.


Jordan S, Morris JK, Davies GI, Tucker D, Thayer DS, Luteijn JM, Morgan M, Garne E, Hansen AV, Klungsøyr K, Engeland A, Boyle B, Dolk H (2016) Selective Serotonin Reuptake Inhibitor (SSRI) antidepressants in Pregnancy and Congenital Anomalies: analysis of linked databases in Wales, Norway and Funen, Denmark. Plos One 11(12): e0165122. doi: 10.1371/journal.pone.0165122

Article Source: Selective Serotonin Reuptake Inhibitor (SSRI) Antidepressants in Pregnancy and Congenital Anomalies: Analysis of Linked Databases in Wales, Norway and Funen, Denmark




June 2021

Signal Detection in EUROmediCAT: Identification and Evaluation of Medication-Congenital Anomaly Associations and Use of VigiBase as a Complementary Source of Reference.  Cavadino A, Sandberg L, Öhman I, Bergvall T, Star K, Dolk H, Loane M, Addor MC, Barisic I, Cavero-Carbonell C, Garne E, Gatt M, Khoshnood B, Klungsøyr K, Latos-Bielenska A, Lelong N, Lutke R, Materna-Kiryluk A, Nelen V, Neville A, O'Mahony M, Mokoroa O, Pierini A, Randrianaivo H, Rissmann A, Tucker D, Wiesel A, Yevtushok L, Morris JK. Drug Saf. 2021 Jul;44(7):765-785. doi: 10.1007/s40264-021-01073-z. Epub 2021 May 9. PMID: 33966183.


February 2021

EUROmediCAT researchers have found that azithromycin, an antibiotic being considered for COVID-19 treatment, could be associated with increased risk of atrioventricular septal defect in babies when taken in the first trimester of pregnancy.  Read the article:  Macrolide and lincosamide antibiotic exposure in the first trimester of pregnancy and risk of congenital anomaly:  A European case-control study


January 2021

Report of the Expert Working Group on Optimising Data on Medicines used in Pregnancy


The UK Expert Working Group included EUROmediCAT members (Rachel Charlton, Helen Dolk, Joan Morris) and can be found here:




December 2020

Professor Sue Jordan of Swansea University and her colleagues recently published the following paper, which suggests that women who stop taking their asthma medicines during pregnancy are at risk of premature birth and are less likely to breastfeed their babies.  As part of the study, the team used data from the Secure Anonymised Information Linkage (SAIL), a state-of-the-art privacy protection system, held at Swansea University and funded by the Welsh Government as part of the national research infrastructure. 

Medicines prescribed for asthma, discontinuation and perinatal outcomes, including breastfeeding: A population cohort analysis   Davies G, Jordan S, Thayer D, Tucker D, Humphreys I (2020) Medicines prescribed for asthma, discontinuation and perinatal outcomes, including breastfeeding: A population cohort analysis. PLOS ONE 15(12): e0242489. 


June 2020 - Update to the EUROmediSAFE inventory

As part of our work on the IMI ConcePTION Project the EUROmediSAFE inventory was updated. The Spreadsheet containing all additional Data Sources for the ConcePTION Data Source Catalogue can be found here


This forms part of the Conception Report D1.1 Spreadsheet containing all additional Data Sources for the ConcePTION Data Source Catalogue, which is also now available for viewing and download from the ConcePTION Website by clicking here.

Risk factors for congenital heart disease: The Baby Hearts Study, a population-based case-control study
. Dolk H, McCullough, N, Callaghan S, Craig B, Given J, Loane M, Lagan B, Bunting B, Boyle B, Dabir T. PLOS ONEFebruary 24, 2020.


Use of prescribed contraception in Northern Ireland 2010-2016Given J, Gray A, Dolk H. The European Journal of Contraception & Reproductive Health Care. 18 Feb 2020.  


Bayesian hierarchical methods in the detection of potentially teratogenic first-trimester medications. Cavadino A, Prieto-Merino D and Morris JK.  Pharmacoepidemiology and Drug Safety, 6 Jan 2020.