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COMPARATIVE SAFETY AND EFFECTIVENESS OF ATYPICAL ANTIPSYCHOTICS IN PREGNANCY

English title COMPARATIVE SAFETY AND EFFECTIVENESS OF ATYPICAL ANTIPSYCHOTICS IN PREGNANCY
Applicant Panchaud Alice
Number 158808
Funding scheme Advanced Postdoc.Mobility
Research institution
Institution of higher education Institution abroad - IACH
Main discipline Methods of Epidemiology and Preventive Medicine
Start/End 01.07.2015 - 30.06.2016
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All Disciplines (2)

Discipline
Methods of Epidemiology and Preventive Medicine
Gynaecology

Keywords (6)

pregnancy; maternal adverse events; antipsychotics; fetotoxicity; effectiveness; epidemiology

Lay Summary (French)

Lead
Sécurité et efficacité des antipsychotiques atypiques chez la femme enceinte
Lay summary

Les affections psychiatriques sont, selon l’OMS,  parmi les principales causes de mauvaise santé et de handicap dans les sociétés occidentales et touchent les femmes généralement avant et pendant les années de procréation. Les antipsychotiques atypiques (de deuxième génération) sont utilisés pour traiter certains troubles psychiatriques, tels que les troubles psychotiques et les troubles bipolaires, ainsi que le traitement de la dépression réfractaire et les troubles anxieux. Comme les femmes enceintes sont généralement exclues des essais cliniques avant la commercialisation des médicaments, les informations concernant le profil de sécurité/risque des médicaments pour la grossesse ne peuvent être recueillies qu’après la mise sur le marché d’un médicament en s’appuyant sur la pharmaco-épidémiologie. Les expositions aux médicaments alors recensées sont alors le résultat de prise intentionnelle ou non (p.ex. conditions qui exigent le traitement ou lors d'une grossesse non planifiée). Même si le nombre et la proportion de grossesses exposées à des antipsychotiques atypiques a augmenté de façon spectaculaire au cours des dernières années, l'efficacité et la sécurité des agents antipsychotiques chez les populations enceintes reste encore largement inconnu. Ce projet de recherche vise à comparer la sécurité et l'efficacité des différents antipsychotiques atypiques, donnés seule ou en polythérapie pendant la grossesse, pour le fœtus et pour la mère en utilisant deux grands sets de données (le registre américains de grossesses sous antipsychotiques atypiques & une base de donnée issue du registre Medicaid (MAX)) afin de répondre aux questions suivantes: 1) quel(s) antipsychotique(s) atypique(s) peut-on recommander chez les femmes en âge de procréer, 2) faut-il arrêter le traitement au cours la grossesse et si oui, quand ?

 

Direct link to Lay Summary Last update: 05.03.2015

Lay Summary (English)

Lead
COMPARATIVE SAFETY AND EFFECTIVENESS OF ATYPICAL ANTIPSYCHOTICS IN PREGNANCY
Lay summary
Psychiatric disorders are among the leading causes of ill-health and disability in
Western societies (WHO website) with an onset in women usually before and during the
childbearing years. Atypical antipsychotic medications (second generation) have over
time increasingly being used to treat a spectrum of psychiatric disorders, including
psychotic disorders and bipolar disorder, as well as treatment of refractory depression
and anxiety disorders. Since pregnant women are typically excluded from clinical
trials, most information regarding the safety/risk profile of drugs during pregnancy is
collected after the drug has been approved and used by pregnant women intentionally
or unintentionally (e.g. conditions require treatment or unplanned pregnancy), using
pharmaco-epidemiology methodology. Even though the number and proportion of
pregnancies exposed to atypical antipsychotics has increased dramatically in recent
years, the effectiveness and safety of antipsychotics agents in pregnant populations is
largely unknown. This research project aims at comparing the safety and effectiveness
of different atypical antipsychotics, given as mono or polytherapy, during pregnancy
for the fetus and the mother using two large data sets (National Pregnancy Registry for
Atypical Antipsychotics & Medicaid Analytic eXtract (MAX)) in order to answer the
clinically relevant questions: 1) which specific atypical antipsychotic to recommend for
women of childbearing age, 2) whether and when to discontinue treatment during
pregnancy.
Direct link to Lay Summary Last update: 05.03.2015

Responsible applicant and co-applicants

Name Institute

Publications

Publication
Anticonvulsants and the risk of perinatal bleeding complicationsA pregnancy cohort study
Panchaud Alice, Cohen Jacqueline M., Patorno Elisabetta, Huybrechts Krista F., Desai Rishi J., Gray Kathryn J., Mogun Helen, Hernandez-Diaz Sonia, Bateman Brian T. (2018), Anticonvulsants and the risk of perinatal bleeding complicationsA pregnancy cohort study, in Neurology, 91(6), e533-e542.
Infant Exposure to Methylphenidate and Duloxetine During Lactation
Collin-Lévesque Laurence, El-Ghaddaf Yosra, Genest Madeleine, Jutras Martin, Leclair Grégoire, Weisskopf Etienne, Panchaud Alice, Ferreira Ema (2018), Infant Exposure to Methylphenidate and Duloxetine During Lactation, in Breastfeeding Medicine, 13(3), 221-225.
Pregnancy outcomes in women on metformin for diabetes or other indications among those seeking teratology information servicesPregnancy outcomes in women on metformin in early pregnancy
Panchaud Alice, Rousson Valentin, Vial Thierry, Bernard Nathalie, Baud David, Amar Emmanuelle, De Santis Marco, Pistelli Alessandra, Dautriche Anne, Beau-Salinas Frederique, Cassina Matteo, Dunstan Hannah, Passier Anneke, Kaplan Yusuf Cem, Duman Mine Kadioglu, Maňáková Eva, Eleftheriou Georgios, Klinger Gil, Winterfeld Ursula, Rothuizen Laura E., Buclin Thierry, Csajka Chantal, Hernandez-Diaz Sonia (2018), Pregnancy outcomes in women on metformin for diabetes or other indications among those seeking teratology information servicesPregnancy outcomes in women on metformin in early pregnancy, in British Journal of Clinical Pharmacology, 84(3), 568-578.
Use of atypical antipsychotics in pregnancy and maternal gestational diabetes.
Panchaud A Hernandez-Diaz S Freeman MP Viguera AC MacDonald SC Sosinsky AZ Cohen LS (2017), Use of atypical antipsychotics in pregnancy and maternal gestational diabetes., in J Psychiatr Res, 95, 84-90.
Pregabalin use early in pregnancy and the risk of major congenital malformations.
Patorno E Bateman BT Huybrechts KF MacDonald SC Cohen JM Desai RJ Panchaud A Mogun H Pennell (2017), Pregabalin use early in pregnancy and the risk of major congenital malformations., in Neurology, 88(21), 2020-2025.
Emerging Role of Zika Virus in Adverse Fetal and Neonatal Outcomes.
Panchaud A Stojanov M Ammerdorffer A Vouga M Baud D. (2016), Emerging Role of Zika Virus in Adverse Fetal and Neonatal Outcomes., in Clinical microbiology Review, 659.
An international registry for women exposed to zika virus during pregnancy: time for answers.
1. A. Panchaud M. Vouga D. Musso D. Baud, An international registry for women exposed to zika virus during pregnancy: time for answers., in Lancet Infectious Disease.
Antipsychotic Medication Use in Pregnancy and Risk of Congenital Malformations: A Cohort Study.
K.F. Huybrechts S. Hernandez-Diaz E. Patorno R.J. Desai H. Mogun S.Z. Dejene, J. Cohen, , A. Panchaud L. Cohen B. T. Bateman., Antipsychotic Medication Use in Pregnancy and Risk of Congenital Malformations: A Cohort Study., in JAMA psychiatry.

Abstract

Psychiatric disorders are among the leading causes of ill-health and disability in Western societies (WHO website) with an onset in women usually before and during the childbearing years. Atypical antipsychotic medications (second generation) have over time increasingly being used to treat a spectrum of psychiatric disorders, including psychotic disorders and bipolar disorder, as well as treatment of refractory depression and anxiety disorders. Since pregnant women are typically excluded from clinical trials, most information regarding the safety/risk profile of drugs during pregnancy is collected after the drug has been approved and used by pregnant women intentionally or unintentionally (e.g. conditions require treatment or unplanned pregnancy), using pharmaco-epidemiology methodology. Even though the number and proportion of pregnancies exposed to atypical antipsychotics has increased dramatically in recent years, the effectiveness and safety of antipsychotics agents in pregnant populations is largely unknown. This research project aims at comparing the safety and effectiveness of different atypical antipsychotics, given as mono or polytherapy, during pregnancy for the fetus and the mother using two large data sets (National Pregnancy Registry for Atypical Antipsychotics & Medicaid Analytic eXtract (MAX)) in order to answer the clinically relevant questions: 1) which specific atypical antipsychotic to recommend for women of childbearing age, 2) whether and when to discontinue treatment during pregnancy.
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