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.

Featured Image

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.


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:

Open access logo



The following have contributed to this page