Publications

2023

Determinants of Vaccination and Willingness to Vaccinate against COVID-19 among Pregnant and Postpartum Women during the Third Wave of the Pandemic: A European Multinational Cross-Sectional Survey

Emeline Maisonneuve, Eva Gerbier, Fatima Tauqeer, Léo Pomar, Guillaume Favre, Ursula Winterfeld, Anneke Passier, Alison Oliver, David Baud, Hedvig Nordeng, Michael Ceulemans and Alice Panchaud

Pledging my time: In utero exposure to acetaminophen and childhood neurodevelopment

Per Damkier

Core Data Elements for Pregnancy Pharmacovigilance Studies Using Primary Source Data Collection Methods: Recommendations from the IMI ConcePTION Project

Jonathan Richardson, Alan Moore, Rebecca Bromley, Michael Stellfeld, Yvonne Geissbühler, Matthew Bluett-Duncan, Ursula Winterfeld, Guillaume Favre, Amalia Alexe, Alison Oliver, Yrea van Rijt-Weetink, Kenneth Hodson, Bita Rezaallah, Eugene van Puijenbroek, David Lewis and Laura Yates

Pregnancy- and birth-related experiences among postpartum women during the third wave of the COVID-19 pandemic — A multinational European study

Robin Araya, Fatima Tauqeer, Michael Ceulemans, Eva Gerbier, Emeline Maisonneuve, Anneke Passier, Alison Oliver, Alice Panchaud, Angela Lupattelli and Hedvig Nordeng

2022

Mental health of pregnant and postpartum women during the third wave of the COVID-19 pandemic: a European cross-sectional study

Fatima Tauqeer, Michael Ceulemans, Eva Gerbier, Anneke Passier, Alison Oliver, Veerle Foulon, Alice Panchaud, Angela Lupattelli and Hedvig Nordeng

The risk of questioning the safety of drugs considered safe in pregnancy at the era of big data: the everlasting case of doxylamine

Alice Panchaud, Brian Cleary, Corinna Weber-Schoendorfer, Svetlana Shechtman, Matteo Cassina, Orna Diav-Citrin and Per Damkier

Reproductive safety of trazodone after maternal exposure in early pregnancy; A comparative ENTIS cohort study

Kim Dao, Svetlana Shechtman, Orna Diav-Citrin, Nathan George, Jonathan Luke Richardson, Victoria Rollason, Alessandra Pistelli, Georgias Eleftheriou, Maya Berlin, Pierre Ekobena, Valentin Rousson, Marie-Claude Addor, David Baud, Thierry Buclin, Alice Panchaud and Ursula Winterfeld

A critical appraisal of controlled studies investigating malformation risks following pregabalin use in early pregnancy

Jonathan Richardson, Per Damkier, Orna Diav-Citrin, Nathan George, Amanda Greenall, Alison Oliver, Sally Stephens and Kenneth Hodson

Self-reported medication use among pregnant and postpartum women during the third wave of the COVID-19 pandemic: A European multinational cross-sectional study

Eva Gerbier, Guillaume Favre, Fatima Tauqeer, Ursula Winterfeld, Milos Stojanov, Alison Oliver, Anneke Passier, Hedvig Nordeng, Léo Pomar, David Baud, Alice Panchaud, Carla Meyer-Massetti and Michael Ceulemans

Information needs and counseling preferences among potential users of the future teratology information service in Belgium: A cross-sectional study involving the public and healthcare professionals

Michael Ceulemans, Kristel van Calsteren, Karel Allegaert and Veerle Foulon

Shelter from the storm: Acetaminophen (paracetamol) in pregnancy, urogenital malformations, and childhood neurodevelopment

Per Damkier and Kenneth Hodson

Self-reported medication se among pregnant and breastfeeding women during the COVID-19 pandemic: A cross-sectional study in five European countries

Michael Ceulemans, Veerle Foulon, Alice Panchaud, Ursula Winterfeld, Leo Pomar, Valentine Lambelet, Brian Cleary, Fergal O’Shaughnessy, Anneke Passier, Jonathan Luke Richardson and Hedvig Nordeng

2021

Vaccine willingness and impact of the COVID-19 pandemic on women’s perinatal experiences and practices- A multinational, cross-sectional study covering the first wave of the pandemic

Michael Ceulemans, Veerle Foulon, Alice Panchaud, Ursula Winterfeld, Leo Pomar, Valentine Lambelet, Brian Cleary, Fergal O’Shaughnessy, Anneke Passier, Jonathan Luke Richardson, Karel Allegaert and Hedvig Nordeng

Handle with care — interpretation, synthesis and dissemination of data on paracetamol in pregnancy

Per Damkier, Brian Cleary, Corinna Weber-Schoendorfer, Svetlana Shechtman, Matteo Cassina, Alice Panchaud & Orna Diav-Cirtin

Ondansetron in pregnancy revisited: Assessment and pregnancy labelling by the European Medicines Agency (EMA) & Pharmacovigilance Risk Assessment Committee (PRAC)

Per Damkier, Yusuf Cem Kaplan, Svetlana Shechtman, Orna Diav-Citrin, Matteo Cassina, Corinna Weber-Schoendorfer

Mental health status of pregnant and breastfeeding women during the COVID-19 pandemic – a multinational cross-sectional study

Michael Ceulemans, Veerle Foulon, Elin Ngo, Alice Panchaud, Ursula Winterfeld, Léo Pomar, Valentine Lambelet, Brian Cleary, Fergal O’Shaughnessy, Anneke Passier, Jonathan Luke Richardson, Titia Hompes and Hedvig Nordeng

2020

BJOG perspectives – Ondansetron should never be used in pregnancy Argument Against: Ondansetron in pregnancy revisited

Per Damkier, Yusuf Cem Kaplan, Svetlana Shechtman, Orna Diav‐Citrin,
Matteo Cassina, Corinna Weber‐Schoendorfer, Brian Cleary, Kenneth Hodson

BJOG 29 September 2020; doi.org/10.1111/1471-0528.16476

Pregnancy outcome following first trimester exposure to fingolimod; a collaborative ENTIS study

Emmanuelle Pauliat, Marlies Onken, Corinna Weber-Schoendorfer, Valentin Rousson, Marie-Claude Addor, David Baud, Marie Théaudin, Orna Diav-Citrin, Judith Cottin, Antonia Agusti, Victoria Rollason, Yusuf C Kaplan, Debra Kennedy, Mine Kadioglu, Laura E Rothuizen, Françoise Livio, Thierry Buclin, Alice Panchaud, Ursula Winterfeld 

Mult Scler 2020 Jun15; Online ahead of print

2018

Pregnancy outcomes in women on metformin for diabetes or other indications among those seeking teratology information services.

Panchaud A, Rousson V, Vial T, Bernard N, Baud D, Amar E, De Santis M, Pistelli A, Dautriche A, Beau-Salinas F, Cassina M, Dunstan H, Passier A, Kaplan YC, Duman MK, Maňáková E, Eleftheriou G, Klinger G, Winterfeld U, Rothuizen LE, Buclin T, Csajka C, Hernandez-Diaz S.

Br J Clin Pharmacol. 2017 Dec 7. doi: 10.1111/bcp.13481. [Epub ahead of print]

2017

Pregnancy outcomes after maternal varenicline use; analysis of surveillance data collected by the European Network of Teratology Information Services.

Richardson JL, Stephens S, Yates LM, Diav-Citrin O, Arnon J, Beghin D, Kayser A, Kennedy D, Cupitt D, Te Winkel B, Peltonen M, Kaplan YC, Thomas SH.
Reprod Toxicol. 2016 Nov 13;67:26-34.

A summary of this study can be reached here

2016

Changing of the Guards: EMA Warning on Paternal Use of Mycophenolate Mofetil: An Unnecessary and Insufficiently Substantiated Precaution.

Damkier P, Passier A, Petersen LB, Havnen G, Petersen AJT.
Birth Defects Res A Clin Mol Teratol. 2016 Sep 28. doi: 10.1002/bdra.23556

A summary of this letter can be reached here

Methylphenidate in pregnancy: a multicenter, prospective, comparative, observational study. 
Diav-Citrin O, Shechtman S, Arnon J, Wajnberg R, Borisch C, Beck E, Richardson JL, Bozzo P, Nulman I, Ornoy A. J Clin Psychiatry. 2016 May 24. [Epub ahead of print]

A summary of this study can be reached here

Pregnancy outcome following maternal exposure to pregabalin may call for concern.
Ursula Winterfeld, PhD, Paul Merlob, MD, David Baud, MD, PhD, Valentin Rousson, PhD, Alice Panchaud, PhD, Laura E. Rothuizen, MD, Nathalie Bernard, PharmD, Thierry Vial, MD, Laura M. Yates, MBChB, Alessandra Pistelli, MD, Maria Ellfolk, PhD, Georgios Eleftheriou, MD, Loes C. de Vries, MD, Annie-Pierre Jonville-Bera, MD, Mine Kadioglu, MD, Jerome Biollaz, MD and Thierry Buclin, MD. Neurology. Published online before print May 18, 2016.

A summary of this study can be reached here

2015

Pregnancy outcome after TNF-α inhibitor therapy during the first trimester: a prospective multicentre cohort study.
Weber-Schoendorfer C, Oppermann M, Wacker E, Bernard N; network of French pharmacovigilance centres, Beghin D, Cuppers-Maarschalkerweerd B, Richardson JL, Rothuizen LE, Pistelli A, Malm H, Eleftheriou G, Kennedy D, Kadioglu Duman M, Meister R, Schaefer C. Br J Clin Pharmacol. 2015 Oct;80(4):727-39.

 

Patterns and factors associated with low adherence to psychotropic medications during pregnancy–a cross-sectional, multinational web-based study.
Lupattelli A, Spigset O, Björnsdóttir I, Hämeen-Anttila K, Mårdby AC, Panchaud A, Juraski RG, Rudolf G, Odalovic M, Drozd M, Twigg MJ, Juch H, Moretti ME, Kennedy D, Rieutord A, Zagorodnikova K, Passier A, Nordeng H. Depress Anxiety. 2015;32(6):426-36.

Pregnancy outcome following maternal exposure to mirtazapine: a multicentre prospective study. 
Winterfeld U, Klinger G, Panchaud A, Stephens S, Arnon J, Malm H, te Winkel B, Clementi M, Pistelli A, Manakova E, Eleftheriou G, Merlob P, Kaplan YC, Buclin T, Rothuizen LE. J Clin Psychopharmacol. 2015;35(3):250-9.

2014

Pregnancy outcome after methotrexate treatment for rheumatic disease prior to or during early pregnancy: a prospective multicenter cohort study.
Weber-Schoendorfer C, Chambers C, Wacker E, Beghin D, Bernard N; Network of French Pharmacovigilance Centers, Shechtman S, Johnson D, Cuppers-Maarschalkerweerd B, Pistelli A, Clementi M, Winterfeld U, Eleftheriou G, Pupco A, Kao K, Malm H, Elefant E, Koren G, Vial T, Ornoy A, Meister R, Schaefer C.  Arthritis Rheumatol 2014; 66: 1101-10.

Medication use in pregnancy: a cross-sectional, multinational web-based study.
Lupattelli A, Spigset O, Twigg MJ, Zagorodnikova K, Mårdby AC, Moretti ME, Drozd M, Panchaud A, Hämeen-Anttila K, Rieutord A, Gjergja Juraski R, Odalovic M, Kennedy D, Rudolf G, Juch H, Passier A, Björnsdóttir I, Nordeng H. BMJ Open. 2014;4(2): e004365.

2013

Author’s response to: Statins in pregnancy: safety and perspectives of therapeutic applications.
Winterfeld U, Allignol A, Panchaud A, Rothuizen LE, Merlob P, Cuppers-Maarschalkerweerd B, Vial T, Stephens S, Clementi M, De Santis M, Pistelli A, Berlin M, Elefteriou J, Maňáková E, Buclin T. BJOG. 2013;120(11):1440.

Pregnancy outcome after maternal exposure to statins: a multicenter prospective study.
Winterfeld U, Allignol A, Panchaud A, Rothuizen LE, Merlob P, Cuppers-Maarschalkerweerd B, Vial T, Stephens S, Clementi M, De Santis M, Pistelli A, Berlin M, Elefteriou J, Maňáková E, Buclin T. BJOG. 2013;120(4):463-71.

2012

Pregnancy Outcome Following Exposure to Topical Retinoids: A Multicenter Prospective Study.
Panchaud A, Csajka C, Merlob P, Schaefer C, Berlin M, De Santis M, Vial T, Ieri A, Malm H, Eleftheriou G, Stahl B, Rousso P, Winterfeld U, Rothuizen LE, Buclin T. J Clin Pharmacol. 2012;52(12):1844-51.

Teratogenicity of mycophenolate confirmed in a prospective study of the European Network of Teratology Information Services.
Hoeltzenbein M, Elefant E, Vial T, Finkel-Pekarsky V, Stephens S, Clementi M, Allignol A, Weber-Schoendorfer C, Schaefer C. Am J Med Genet A. 2012 Mar;158A(3):588-96.

The outcomes of pregnancy in women exposed to the new macrolides in the first trimester: a prospective, multicentre, observational study. 
Bar-Oz B, Weber-Schoendorfer C, Berlin M, Clementi M, Di Gianantonio E, de Vries L, De Santis M, Merlob P, Stahl B, Eleftheriou G, Maňáková E, Hubičková-Heringová L, Youngster I, Berkovitch M. Drug Saf. 2012 Jul 1;35(7):589-98.

Rates of major malformations in infants following exposure to duloxetine during pregnancy: a preliminary report.
Einarson A, Smart K, Vial T, Diav-Citrin O, Yates L, Stephens S, Pistelli A, Kennedy D, Taylor T, Panchaud A, Malm H, Koren G, Einarson TR. J Clin Psychiatry. 2012 Nov;73(11):1471.

Pregnancy outcomes following use of escitalopram: a prospective comparative cohort study.
Klieger-Grossmann C, Weitzner B, Panchaud A, Pistelli A, Einarson T, Koren G, Einarson A.J Clin Pharmacol. 2012 May;52(5):766-70.

2008

Using observational cohort data for studying drug effects on pregnancy outcome–methodological considerations.
Schaefer C, Ornoy A, Clementi M, Meister R, Weber-Schoendorfer C.  Reprod Toxicol. 2008 Sep;26(1):36-41

Paroxetine and fluoxetine  in pregnancy: a prospective, multicentre, controlled, observational study.  
Diav-Citrin O, Shechtman S, Weinbaum D, Wajnberg R, Avgil M, Di Gianantonio E, Clementi M, Weber-Schoendorfer C, Schaefer C, Ornoy A.  Br J Clin Pharmacol. 2008 Nov;66(5):695-705.

 

The safety of calcium channel blockers during pregnancy: a prospective, multicenter, observational study. 
Weber-Schoendorfer C, Hannemann D, Meister R, Eléfant E, Cuppers-Maarschalkerweerd B, Arnon J, Vial T, Rodriguez-Pinilla E, Clementi M, Robert-Gnansia E, De Santis M, Malm H, Dolivo A, Schaefer C. Reprod Toxicol. 2008;26(1):24-30.

Evaluation of the risk of congenital cardiovascular defects associated with use of paroxetine during pregnancy.
Einarson A, Pistelli A, DeSantis M, Malm H, Paulus WD, Panchaud A, Kennedy D, Einarson TR, Koren G. Am J Psychiatry. 2008 Jun;165(6):749-52.

2006

Vitamin K antagonists and pregnancy outcome. A multi-centre prospective study. Schaefer C, Hannemann D, Meister R, Eléfant E, Paulus W, Vial T, Reuvers M, Robert-Gnansia E, Arnon J, De Santis M, Clementi M, Rodriguez-Pinilla E, Dolivo A, Merlob P. Thromb Haemost. 2006;95(6):949-57.

2005

Post-marketing surveillance system for drugs in pregnancy–15 years experience of ENTIS.
Schaefer C, Hannemann D, Meister R. Reprod Toxicol. 2005;20(3):331-43.

Safety of haloperidol and penfluridol in pregnancy: a multicenter, prospective, controlled study.
Diav-Citrin O, Shechtman S, Ornoy S, Arnon J, Schaefer C, Garbis H, Clementi M, Ornoy A. J Clin Psychiatry. 2005;66(3):317-22.

Pregnancy outcome after exposure to ranitidine and other H2-blockers. A collaborative study of the European Network of Teratology Information Services.
Garbis H, Elefant E, Diav-Citrin O, Mastroiacovo P, Schaefer C, Vial T, Clementi M, Valti E, McElhatton P, Smorlesi C, Rodriguez EP, Robert-Gnansia E, Merlob P, Peiker G, Pexieder T, Schueler L, Ritvanen A, Mathieu-Nolf M. Reprod Toxicol. 2005;19(4):453-8.

The safety of proton pump inhibitors in pregnancy: a multicentre prospective controlled study.
Diav-Citrin O, Arnon J, Shechtman S, Schaefer C, van Tonningen MR, Clementi M, De Santis M, Robert-Gnansia E, Valti E, Malm H, Ornoy A. Aliment Pharmacol Ther. 2005;21(3):269-75.

 

2001

Adverse effects of prenatal methimazole exposure.
Di Gianantonio E, Schaefer C, Mastroiacovo PP, Cournot MP, Benedicenti F, Reuvers M, Occupati B, Robert E, Bellemin B, Addis A, Arnon J, Clementi M. Teratology. 2001;64(5):262-6.

 

1999

Exposure to yellow fever vaccine in early pregnancy.
Robert E, Vial T, Schaefer C, Arnon J, Reuvers M. Vaccine. 1999;17(3):283-5.

High vitamin A intake in early pregnancy and major malformations: a multicenter prospective controlled study.
Mastroiacovo P, Mazzone T, Addis A, Elephant E, Carlier P, Vial T, Garbis H, Robert E, Bonati M, Ornoy A, Finardi A, Schaffer C, Caramelli L, Rodríguez-Pinilla E, Clementi M. Teratology. 1999;59(1):7-11.

1996

Pregnancy outcome after prenatal quinolone exposure. Evaluation of a case registry of the European Network of Teratology Information Services (ENTIS).
Schaefer C, Amoura-Elefant E, Vial T, Ornoy A, Garbis H, Robert E, Rodriguez-Pinilla E, Pexieder T, Prapas N, Merlob P. Eur J Obstet Gynecol Reprod Biol. 1996;69(2):83-9.

The outcome of pregnancy in 689 women exposed to therapeutic doses of antidepressants. A collaborative study of the European Network of Teratology Information Services (ENTIS).
McElhatton PR, Garbis HM, Eléfant E, Vial T, Bellemin B, Mastroiacovo P, Arnon J, Rodríguez-Pinilla E, Schaefer C, Pexieder T, Merlob P, Dal Verme S. Reprod Toxicol. 1996;10(4):285-94.