Collaborative ENTIS Studies


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

Per Damkier and Kenneth Hodson


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 CeulemansVeerle FoulonElin NgoAlice PanchaudUrsula WinterfeldLéo PomarValentine LambeletBrian ClearyFergal O’ShaughnessyAnneke PassierJonathan Luke RichardsonTitia Hompes and Hedvig Nordeng


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;

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

Emmanuelle PauliatMarlies OnkenCorinna Weber-SchoendorferValentin RoussonMarie-Claude AddorDavid BaudMarie ThéaudinOrna Diav-CitrinJudith CottinAntonia AgustiVictoria RollasonYusuf C KaplanDebra KennedyMine KadiogluLaura E RothuizenFrançoise Livio, Thierry BuclinAlice PanchaudUrsula Winterfeld 

Mult Scler 2020 Jun15; Online ahead of print


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]


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


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


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.


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.


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.


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.


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.


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.


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.



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.



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.


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.