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Cited by 34Pregnancy and Medication ImpactPharmacological Effects and Toxicity StudiesMaternal Mental Health During Pregnancy and Postpartum

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Pregnancy Outcome Following Maternal Exposure to Mirtazapine: A Multicenter, Prospective Study

Open access
Winterfeld, Ursula, Klinger, Gil, Panchaud, Alice, Stephens, Sally, Arnon, Judy, Malm, Heli, te Winkel, Bernke, Clementi, Maurizio, Pistelli, Alessandra, Maňáková, Eva, Eleftheriou, Georgios, Merlob, Paul, Kaplan, Yusuf C., Buclin, Thierry, Rothuizen, Laura E.·2015·Journal of Clinical Psychopharmacology
DOI 10.1097/jcp.0000000000000309
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Abstract

This multicenter, observational prospective cohort study addresses the risk associated with exposure to mirtazapine during pregnancy. Pregnancy outcomes after exposure to mirtazapine were compared with 2 matched control groups: (1) exposure to any selective serotonin reuptake inhibitor (SSRI, control subjects with a psychiatric condition) and (2) no exposure to medication known to be teratogenic or any antidepressant (general control subjects). Data were collected by members of the European Network of Teratology Information Services between 1995 and 2011. Observations from 357 exposed pregnancies were compared with 357 pregnancies from each control group. The rate of major birth defects between the mirtazapine and the SSRI group did not differ significantly (4.5% vs 4.2%; odds ratio [OR], 1.1; 95% confidence interval [95% CI], 0.5-2.3; P = 0.9). A trend toward a higher rate of birth defects in the mirtazapine group compared with general control subjects (4.5% vs 1.9%; OR, 2.4; 95% CI, 0.9-6.3; P = 0.08) reached statistical significance after exclusion of chromosomal or genetic anomalies (4.1% vs 1.3%; OR, 3.3; 95% CI, 1.04-10.3; P = 0.03), but this difference became again nonsignificant if cases of exposure not comprising the first trimester were excluded from the analysis (3.4% vs 1.9%; OR, 1.8; 95% CI, 0.6-5.0; P = 0.26). The crude miscarriage rate did not differ significantly between the mirtazapine, the SSRI, and the general control groups (12.1% vs 12.0% vs 9.3%; P = 0.44). However, a higher rate of elective pregnancy termination was observed in the mirtazapine group compared with SSRI and general control subjects (7.8% vs 3.4% vs 5.6%; P = 0.03). This study did not observe a statistically significant difference in the rate of major birth defects after first-trimester exposure between mirtazapine, SSRI-exposed, and nonexposed pregnancies. A marginally higher rate of birth defects was, however, observed in the mirtazapine and SSRI groups compared with the low rate of birth defects in our general control subjects. Overall pregnancy outcome after mirtazapine exposure was similar to that of the SSRI-exposed control group.

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Metadata

Authors
Winterfeld, U., Klinger, G., Panchaud, A., Stephens, S., Arnon, J., Malm, H., te Winkel, B., Clementi, M., Pistelli, A., Maňáková, E., Eleftheriou, G., Merlob, P., Kaplan, Y. C., Buclin, T., & Rothuizen, L. E.
Affiliations
  • University of Geneva (CH)
  • Tel Aviv University (IL)
  • Izmir Kâtip Çelebi University (TR)
  • Helsinki University Hospital (FI)
  • Centre Hospitalier Universitaire Vaudois (CH)
Corresponding author
  • Winterfeld, Ursula
  • Panchaud, Alice
  • Clementi, Maurizio
  • Buclin, Thierry
  • Rothuizen, Laura E.
ORCID
Venue
Journal of Clinical Psychopharmacology
Publisher
Ovid Technologies (Wolters Kluwer Health)
Published
2015-06
Volume
35
Issue
3
Pages
250-259
ISSN
0271-0749 (ISSN-L)
DOI
10.1097/jcp.0000000000000309
OpenAlex
W2057462599
Cited by
34
References
34
Citations by year
2024: 5 · 2023: 1 · 2022: 4 · 2021: 2 · 2020: 6 · 2019: 4 · 2018: 3 · 2017: 5 · 2016: 4
FWCI
4.29
Type
journal article
Language
en
Open access
Locations
  • Journal of Clinical Psychopharmacology (publishedVersion)
  • PubMed (publishedVersion)
  • SERVAL (Université de Lausanne) (publishedVersion)
  • IRIS (submittedVersion)
  • Newcastle University ePrints (Newcastle Univesity)
Topics
  • Health Sciences › Medicine › Public Health, Environmental and Occupational Health › Pregnancy and Medication Impact
  • Health Sciences › Medicine › Pediatrics, Perinatology and Child Health › Pharmacological Effects and Toxicity Studies
  • Health Sciences › Medicine › Public Health, Environmental and Occupational Health › Maternal Mental Health During Pregnancy and Postpartum
Keywords
mirtazapine, pregnancy outcomes, congenital malformations, selective serotonin reuptake inhibitors, antidepressants, teratogenicity, miscarriage, first trimester exposure, psychiatric disorders in pregnancy, drug safety in pregnancy, antidepressant safety in pregnancy
MeSH terms
Abnormalities, Drug-Induced, Mirtazapine, Adult, Antidepressive Agents, Birth Weight, Depressive Disorder, Female, Gestational Age, Humans, Mianserin, Pregnancy, Pregnancy Complications, Pregnancy Outcome, Prospective Studies, Case-Control Studies, Selective Serotonin Reuptake Inhibitors

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