What is it about?
In a nationwide register-based study, all women with pregnancies ending in a live birth or stillbirth in Denmark and Sweden were analyzed. From more than 2 million births identified, information on drug exposure, comorbidities, education and income, and congenital malformations and stillbirths was gathered. The analyses taking into account factors beyond duloxetine exposure did not reveal associations between exposure to duloxetine during pregnancy and risk for malformations or stillbirth.
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Why is it important?
Many women of reproductive age take drugs used to treat depression, including duloxetine, a selective serotonin-norepinephrine reuptake inhibitor (SNRI) There is a need for information on the possible association between exposure to duloxetine and malformation or stillbirth among offspring.
Perspectives
Based on this observational register-based nationwide study with data from Sweden and Denmark, no increased risk of major and minor congenital malformations or stillbirths was associated with exposure to duloxetine during pregnancy. This publication is based on a post-authorization safety study (PASS) on duloxetine requested by the Food and Drug Administration (FDA). Eli Lilly and Company funded the PASS study. The funder had the opportunity to comment study design, data collection and analysis, where to publish and preparation of the manuscript, but the first and last authors had the final decisions.
Mikkel Ankarfeldt
Read the Original
This page is a summary of: Exposure to duloxetine during pregnancy and risk of congenital malformations and stillbirth: A nationwide cohort study in Denmark and Sweden, PLoS Medicine, November 2021, PLOS,
DOI: 10.1371/journal.pmed.1003851.
You can read the full text:
Resources
Duloxetine Exposure During Pregnancy and the Risk of Offspring Being Born Small for Gestational Age or Prematurely: A Nationwide Danish and Swedish Safety Study
From the same author group, and a similar cohort: Another study on duloxetine, but the Risk of Offspring Being Born Small for Gestational Age or Prematurely,
Duloxetine Exposure During Pregnancy and the Risk of Spontaneous and Elective Abortion: A Danish Nationwide Observational Study
From the same author group, and a danish cohort : Another study on duloxetine, but the Risk of Spontaneous and Elective Abortion
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