Cargando…
Mirtazapine exposure in pregnancy and fetal safety: A nationwide cohort study
OBJECTIVE: To investigate the association between mirtazapine exposure in pregnancy and risk of specific adverse pregnancy outcomes. METHODS: A register‐based nationwide cohort study was conducted including all registered pregnancies in Denmark from 1997 to 2016. Mirtazapine‐exposed pregnancies were...
Autores principales: | , , , , , |
---|---|
Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
John Wiley and Sons Inc.
2022
|
Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9321713/ https://www.ncbi.nlm.nih.gov/pubmed/35320582 http://dx.doi.org/10.1111/acps.13431 |
_version_ | 1784756115382206464 |
---|---|
author | Ostenfeld, Anne Petersen, Tonny Studsgaard Pedersen, Lars Henning Westergaard, Hanne Brix Løkkegaard, Ellen Christine Leth Andersen, Jon Trærup |
author_facet | Ostenfeld, Anne Petersen, Tonny Studsgaard Pedersen, Lars Henning Westergaard, Hanne Brix Løkkegaard, Ellen Christine Leth Andersen, Jon Trærup |
author_sort | Ostenfeld, Anne |
collection | PubMed |
description | OBJECTIVE: To investigate the association between mirtazapine exposure in pregnancy and risk of specific adverse pregnancy outcomes. METHODS: A register‐based nationwide cohort study was conducted including all registered pregnancies in Denmark from 1997 to 2016. Mirtazapine‐exposed pregnancies were compared with mirtazapine unexposed pregnancies in a 1:4 ratio matched according to propensity scores. Outcomes were major congenital malformations analyzed using log binomial models, and spontaneous abortion, stillbirth and neonatal death analyzed using Cox proportional hazard regression. RESULTS: From a source population of 1,650,649 pregnancies, the propensity score‐matched cohort included 4475 pregnancies (895 mirtazapine exposed) in the analysis of major congenital malformations. The analyses of spontaneous abortion included 9 500 pregnancies (1900 mirtazapine exposed), and for the analyses of stillbirths and neonatal deaths 9725 (1 945 mirtazapine‐exposed) and 4485 pregnancies (897 mirtazapine‐exposed) were included, respectively. Thirty‐one (3.5%) children were diagnosed with major congenital malformation among the mirtazapine exposed compared with 152 (4.3%) among the unexposed pregnancies (OR=0.81, 95% CI 0.55–1.20). Spontaneous abortion occurred in 237 (12.5%) of the mirtazapine exposed compared with 931 (12.3%) of the unexposed pregnancies (HR = 1.04%, 95% CI 0.91–1.20). The analyses revealed no increased risk of stillbirth (HR = 0.88%, 95% CI 0.34–2.29) or neonatal death (HR = 0.60%, 95% CI 0.18–2.02). CONCLUSIONS: In this nationwide Danish register study, mirtazapine exposure in pregnancy was not associated with major congenital malformations, spontaneous abortion, stillbirth, or neonatal death. Clinicians and patients can be reassured that mirtazapine is safe in pregnancy. |
format | Online Article Text |
id | pubmed-9321713 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2022 |
publisher | John Wiley and Sons Inc. |
record_format | MEDLINE/PubMed |
spelling | pubmed-93217132022-07-30 Mirtazapine exposure in pregnancy and fetal safety: A nationwide cohort study Ostenfeld, Anne Petersen, Tonny Studsgaard Pedersen, Lars Henning Westergaard, Hanne Brix Løkkegaard, Ellen Christine Leth Andersen, Jon Trærup Acta Psychiatr Scand Original Articles OBJECTIVE: To investigate the association between mirtazapine exposure in pregnancy and risk of specific adverse pregnancy outcomes. METHODS: A register‐based nationwide cohort study was conducted including all registered pregnancies in Denmark from 1997 to 2016. Mirtazapine‐exposed pregnancies were compared with mirtazapine unexposed pregnancies in a 1:4 ratio matched according to propensity scores. Outcomes were major congenital malformations analyzed using log binomial models, and spontaneous abortion, stillbirth and neonatal death analyzed using Cox proportional hazard regression. RESULTS: From a source population of 1,650,649 pregnancies, the propensity score‐matched cohort included 4475 pregnancies (895 mirtazapine exposed) in the analysis of major congenital malformations. The analyses of spontaneous abortion included 9 500 pregnancies (1900 mirtazapine exposed), and for the analyses of stillbirths and neonatal deaths 9725 (1 945 mirtazapine‐exposed) and 4485 pregnancies (897 mirtazapine‐exposed) were included, respectively. Thirty‐one (3.5%) children were diagnosed with major congenital malformation among the mirtazapine exposed compared with 152 (4.3%) among the unexposed pregnancies (OR=0.81, 95% CI 0.55–1.20). Spontaneous abortion occurred in 237 (12.5%) of the mirtazapine exposed compared with 931 (12.3%) of the unexposed pregnancies (HR = 1.04%, 95% CI 0.91–1.20). The analyses revealed no increased risk of stillbirth (HR = 0.88%, 95% CI 0.34–2.29) or neonatal death (HR = 0.60%, 95% CI 0.18–2.02). CONCLUSIONS: In this nationwide Danish register study, mirtazapine exposure in pregnancy was not associated with major congenital malformations, spontaneous abortion, stillbirth, or neonatal death. Clinicians and patients can be reassured that mirtazapine is safe in pregnancy. John Wiley and Sons Inc. 2022-04-01 2022-06 /pmc/articles/PMC9321713/ /pubmed/35320582 http://dx.doi.org/10.1111/acps.13431 Text en © 2022 The Authors. Acta Psychiatrica Scandinavica published by John Wiley & Sons Ltd. https://creativecommons.org/licenses/by-nc-nd/4.0/This is an open access article under the terms of the http://creativecommons.org/licenses/by-nc-nd/4.0/ (https://creativecommons.org/licenses/by-nc-nd/4.0/) License, which permits use and distribution in any medium, provided the original work is properly cited, the use is non‐commercial and no modifications or adaptations are made. |
spellingShingle | Original Articles Ostenfeld, Anne Petersen, Tonny Studsgaard Pedersen, Lars Henning Westergaard, Hanne Brix Løkkegaard, Ellen Christine Leth Andersen, Jon Trærup Mirtazapine exposure in pregnancy and fetal safety: A nationwide cohort study |
title | Mirtazapine exposure in pregnancy and fetal safety: A nationwide cohort study |
title_full | Mirtazapine exposure in pregnancy and fetal safety: A nationwide cohort study |
title_fullStr | Mirtazapine exposure in pregnancy and fetal safety: A nationwide cohort study |
title_full_unstemmed | Mirtazapine exposure in pregnancy and fetal safety: A nationwide cohort study |
title_short | Mirtazapine exposure in pregnancy and fetal safety: A nationwide cohort study |
title_sort | mirtazapine exposure in pregnancy and fetal safety: a nationwide cohort study |
topic | Original Articles |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9321713/ https://www.ncbi.nlm.nih.gov/pubmed/35320582 http://dx.doi.org/10.1111/acps.13431 |
work_keys_str_mv | AT ostenfeldanne mirtazapineexposureinpregnancyandfetalsafetyanationwidecohortstudy AT petersentonnystudsgaard mirtazapineexposureinpregnancyandfetalsafetyanationwidecohortstudy AT pedersenlarshenning mirtazapineexposureinpregnancyandfetalsafetyanationwidecohortstudy AT westergaardhannebrix mirtazapineexposureinpregnancyandfetalsafetyanationwidecohortstudy AT løkkegaardellenchristineleth mirtazapineexposureinpregnancyandfetalsafetyanationwidecohortstudy AT andersenjontrærup mirtazapineexposureinpregnancyandfetalsafetyanationwidecohortstudy |