Publications

2025


Damkier P and Berkovitch M.


Richardson JL, Moore A, Stellfeld M, Geissbühler Y, Winterfeld U, Favre G, Chambers C, Beck E, Onken M, Dathe K, Ceulemans M, Diav-Citrin O, Shechtman S, Oliver AM, Hodson KK, Shiller DD, Alexe A, van Puijenbroek EP, Lewis DJ, Yates LM.


2024


Per Damkier, Erika Gram, Michael Ceulemans, Alice Panchaud, Brian Cleary, Christina Chambers, Corinna Weber-Schoendorfer, Debra Kennedy, Ken Hodson, Kimberly Grant, Orna Diav-Citrin, Sarah Običan, Svetlana Shechtman and Sarah Alwan


Joan Garey, Per Damkier, Anthony Scialli, Shari Lusskin, Stephen Braddock, Laurent Chouchana, Brian Cleary, Elizabeth Conover, Orna Diav-Citrin, Rachel Dragovich, Facundo Garcia-Bournissen, Kenneth Hodson, Debra Kennedy, Steven Lamm, Sharon Lavigne, Sarah Običan, Alice Panchaud, Kirstie Perrotta, Alfred Romeo, Svetlana Shechtman and Corinna Weber-Schoendorfer


Marlies Onken, Lukas Lohse, Bénédicte Coulm, Delphine Beghin, Jonathan Richardson, Eva Bermejo-Sánchez, Cristina Aguilera, Montserrat Bosch, Matteo Cassina, Laurent Chouchana, Marco De Santis, Mine Kadioglu Duman, M. Zafer Gören, Diana Johnson, Annie Pierre Jonville Bera, Yusuf C. Kaplan, Debra Kennedy, Susan Kwok, Isabelle Lacroix, Marion Lepelley, Alessandra Pistelli, Christof Schaefer, Bernke Te Winkel, Nusret Uysal, Ursula Winterfeld, Naho Yakuwa, Orna Diav-Citrin, Thierry Vial and Katarina Dathe


Kim Dao, Svetlana Shechtman, Corinna Weber-Schoendorfer, Orna Diav-Citrin, Reem Hegla Murad, Maya Berlin, Ariela Hazan, Jonathan Richardson, Georgios Eleftheriou, Valentin Rousson, Leonore Diezi, David Haefliger, Ana Paula Simões-Wüst, Marie-Claude Addor, David Baud, Faiza Lamine, Alice Panchaud, Thierry Buclin, François R Girardin and Ursula Winterfeld


Michael Ceulemans, Per Damkier, Alice Panchaud


2023


Guillaume Favre, Jonathan L Richardson, Alan Moore, Yvonne Geissbühler, Valentine Jehl, Alison Oliver, Svetlana Shechtman, Orna Diav-Citrin, Maya Berlin, Tal De Haan, David Baud, Alice Panchaud, Anil Mor, Meritxell Sabidó, Sabrina de Souza, Christina Chambers, Yrea R J van Rijt-Weetink, Eugène P van Puijenbroek, Laura M Yates, François Girardin, Michael Stellfeld, Ursula Winterfeld


Marlies Onken, Lukas Lohse, Bénédicte Coulm, Delphine Beghin, Jonathan L Richardson, Eva Bermejo-Sánchez, Cristina Aguilera, Montserrat Bosch, Matteo Cassina, Laurent Chouchana, Marco De Santis, Mine Kadioglu Duman, M Zafer Gören, Diana Johnson, Annie Pierre Jonville Bera, Yusuf C Kaplan, Debra Kennedy, Susan Kwok, Isabelle Lacroix, Marion Lepelley, Alessandra Pistelli, Christof Schaefer, Bernke Te Winkel, Nusret Uysal, Ursula Winterfeld, Naho Yakuwa, Orna Diav-Citrin, Thierry Vial, Katarina Dathe


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


Per Damkier


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


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


2022


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


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


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


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


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


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


Per Damkier and Kenneth Hodson


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


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


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.