Risk of Pregnancy Termination and Congenital Anomalies After Domperidone Exposure: A Study in the EFEMERIS Database

Mélanie Araujo (), Clémentine Vabre (), Justine Benevent (), Agnès Sommet (), Christine Damase-Michel (), Caroline Hurault-Delarue () and Isabelle Lacroix ()
Additional contact information
Mélanie Araujo: Réseau REGARDS, Laboratoire de Pharmacologie Médicale et Clinique (Medical and Clinical Pharmacology Laboratory), Centre Hospitalier Universitaire de Toulouse (Toulouse University Hospital Centre), Centre d’Epidémiologie et de Recherche en santé des POPulations (Center for Epidemiology and Research in POPulation health, CERPOP), INSERM UMR 1295, Equipe SPHERE: Study of Perinatal, paediatric and adolescent Health: Epidemiological Research and Evaluation, Faculté de Médecine de Toulouse (Toulouse Faculty of Medicine)
Clémentine Vabre: Réseau REGARDS, Laboratoire de Pharmacologie Médicale et Clinique (Medical and Clinical Pharmacology Laboratory), Centre Hospitalier Universitaire de Toulouse (Toulouse University Hospital Centre), Centre d’Epidémiologie et de Recherche en santé des POPulations (Center for Epidemiology and Research in POPulation health, CERPOP), INSERM UMR 1295, Equipe SPHERE: Study of Perinatal, paediatric and adolescent Health: Epidemiological Research and Evaluation, Faculté de Médecine de Toulouse (Toulouse Faculty of Medicine)
Justine Benevent: Réseau REGARDS, Laboratoire de Pharmacologie Médicale et Clinique (Medical and Clinical Pharmacology Laboratory), Centre Hospitalier Universitaire de Toulouse (Toulouse University Hospital Centre), Centre d’Epidémiologie et de Recherche en santé des POPulations (Center for Epidemiology and Research in POPulation health, CERPOP), INSERM UMR 1295, Equipe SPHERE: Study of Perinatal, paediatric and adolescent Health: Epidemiological Research and Evaluation, Faculté de Médecine de Toulouse (Toulouse Faculty of Medicine)
Agnès Sommet: Réseau REGARDS, Laboratoire de Pharmacologie Médicale et Clinique (Medical and Clinical Pharmacology Laboratory), CIC 1436, Centre Hospitalier Universitaire de Toulouse (Toulouse University Hospital Centre), Centre d’Epidémiologie et de Recherche en santé des POPulations (Center for Epidemiology and Research in POPulation health, CERPOP), INSERM UMR 1295, Equipe SPHERE: Study of Perinatal, paediatric and adolescent Health: Epidemiological Research and Evaluation, Faculté de Médecine de Toulouse (Toulouse Faculty of Medicine)
Christine Damase-Michel: Réseau REGARDS, Laboratoire de Pharmacologie Médicale et Clinique (Medical and Clinical Pharmacology Laboratory), Centre Hospitalier Universitaire de Toulouse (Toulouse University Hospital Centre), Centre d’Epidémiologie et de Recherche en santé des POPulations (Center for Epidemiology and Research in POPulation health, CERPOP), INSERM UMR 1295, Equipe SPHERE: Study of Perinatal, paediatric and adolescent Health: Epidemiological Research and Evaluation, Faculté de Médecine de Toulouse (Toulouse Faculty of Medicine)
Caroline Hurault-Delarue: Réseau REGARDS, Laboratoire de Pharmacologie Médicale et Clinique (Medical and Clinical Pharmacology Laboratory), Centre Hospitalier Universitaire de Toulouse (Toulouse University Hospital Centre), Centre d’Epidémiologie et de Recherche en santé des POPulations (Center for Epidemiology and Research in POPulation health, CERPOP), INSERM UMR 1295, Equipe SPHERE: Study of Perinatal, paediatric and adolescent Health: Epidemiological Research and Evaluation, Faculté de Médecine de Toulouse (Toulouse Faculty of Medicine)
Isabelle Lacroix: Réseau REGARDS, Laboratoire de Pharmacologie Médicale et Clinique (Medical and Clinical Pharmacology Laboratory), Centre Hospitalier Universitaire de Toulouse (Toulouse University Hospital Centre), Centre d’Epidémiologie et de Recherche en santé des POPulations (Center for Epidemiology and Research in POPulation health, CERPOP), INSERM UMR 1295, Equipe SPHERE: Study of Perinatal, paediatric and adolescent Health: Epidemiological Research and Evaluation, Faculté de Médecine de Toulouse (Toulouse Faculty of Medicine)

Drug Safety, 2021, vol. 44, issue 7, No 6, 787-796

Abstract: Abstract Introduction Domperidone is widely used during pregnancy, although the risks associated with pregnant women have not been adequately evaluated. Objective The objective of this study was to compare the rate of pregnancy outcomes and congenital anomalies between pregnant women exposed and unexposed to domperidone during pregnancy. Methods We conducted a retrospective cohort study comparing pregnant women exposed and unexposed to domperidone during pregnancy. We used the EFEMERIS database containing the prescriptions and dispensing of drugs to pregnant women in Haute-Garonne, who had a pregnancy outcome between July 2004 and December 2017. We compared pregnant women who were exposed to domperidone at least once during pregnancy to unexposed pregnant women. Logistic regression and Cox proportional risk models were applied. Results Overall, 13,964 pregnancies (10.3% of pregnancies) were given domperidone. A reduction in the number of pregnant women exposed to domperidone (2004: 17.1% to 2017: 1.2%) was noted. More than 75% of pregnancies were exposed to domperidone in the first trimester of pregnancy. The rate of natural pregnancy termination in pregnant women exposed to domperidone was lower than that in unexposed pregnant women (adjusted hazard ratio = 0.78 [0.71–0.87]). The malformation rate in fetuses/newborns exposed in utero (first trimester) to domperidone is comparable to that of unexposed fetuses/newborns (adjusted odd ratio = 0.89 [0.77–1.03]). Conclusions This is the first comparative study to enrol a large number of pregnant women exposed to domperidone. Data regarding the malformation rate following exposure to domperidone during the first trimester of pregnancy are reassuring. Women exposed to domperidone during pregnancy have a decreased risk for natural pregnancy termination, probably owing to an indication bias.

Date: 2021
References: View complete reference list from CitEc
Citations:

Downloads: (external link)
http://link.springer.com/10.1007/s40264-021-01077-9 Abstract (text/html)
Access to the full text of the articles in this series is restricted.

Related works:
This item may be available elsewhere in EconPapers: Search for items with the same title.

Export reference: BibTeX RIS (EndNote, ProCite, RefMan) HTML/Text

Persistent link: https://EconPapers.repec.org/RePEc:spr:drugsa:v:44:y:2021:i:7:d:10.1007_s40264-021-01077-9

Ordering information: This journal article can be ordered from
http://www.springer.com/adis/journal/40264

DOI: 10.1007/s40264-021-01077-9

Access Statistics for this article

Drug Safety is currently edited by Nitin Joshi

More articles in Drug Safety from Springer
Bibliographic data for series maintained by Sonal Shukla () and Springer Nature Abstracting and Indexing ().