Duloxetine Exposure During Pregnancy and the Risk of Offspring Being Born Small for Gestational Age or Prematurely: A Nationwide Danish and Swedish Safety Study

Drugs - Real World Outcomes - Tập 10 - Trang 69-81 - 2022
Mikkel Zöllner Ankarfeldt1, Janne Petersen1,2, Jon Trærup Andersen3,4, Maria Fernanda Scantamburlo Fernandes5, Hu Li5, Stephen Paul Motsko, Thomas Fast6, Espen Jimenez-Solem1,3,4
1Copenhagen Phase IV Unit (Phase4CPH), Department of Clinical Pharmacology and Center for Clinical Research and Prevention, Copenhagen University Hospital Bispebjerg and Frederiksberg, Frederiksberg, Denmark
2Section for Biostatistics, Department of Public Health, University of Copenhagen, Copenhagen, Denmark
3Department of Clinical Pharmacology, Copenhagen University Hospital Bispebjerg and Frederiksberg, Copenhagen, Denmark
4Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark
5Eli Lilly and Company, Indianapolis, USA
6Institute of Applied Economics & Health Research, Copenhagen, Denmark

Tóm tắt

Depression or depressive symptoms are common among pregnant women. The use of antidepressants during pregnancy has grown steadily. The risk of offspring being born small for gestational age or prematurely when exposed to duloxetine during pregnancy is not established. We aimed to investigate the association between duloxetine exposure during pregnancy and offspring being born small for gestational age or prematurely. We conducted an observational study including live births in Sweden and Denmark (2004–2016). Duloxetine exposure during early (0–140 days) or late (141 to delivery) pregnancy compared with duloxetine-non-exposed, selective serotonin reuptake inhibitor-exposed, venlafaxine-exposed, and duloxetine discontinuers. In total, 2,083,467 pregnancies were identified, where 1589 and 450 were duloxetine exposed in early and late pregnancy, respectively. For small for gestational age, no increased risk was seen for duloxetine across comparators. In the early and late exposure windows, propensity score-matched odds ratios for small for gestational age ranged between 0.64 (95% confidence interval 0.44–0.95) and 1.48 (95% confidence interval 0.85–2.57). For preterm birth, the findings differed across comparators and exposure-time windows, but trended towards an increased risk for duloxetine-exposed when compared with duloxetine-non-exposed, selective serotonin reuptake inhibitor-exposed, and duloxetine discontinuers in both early exposure and late exposure. The odds ratios ranged between 1.17 and 2.04, of which some did not reach statistical significance. No clear association was observed when compared with venlafaxine exposed, 0.91 (95% confidence interval 0.73–1.14) for early exposure and 1.26 (95% confidence interval 0.86–1.86) for late exposure. Most preterm births (79.2%) occurred in weeks 33–36 of gestation. Duloxetine exposure during pregnancy is unlikely to increase the risk of small for gestational age. Although not consequently statistically significant across comparisons, a trend towards an increased risk of preterm birth was observed for duloxetine exposed. Therefore, an increased risk of preterm birth cannot be excluded, especially for women exposed to duloxetine throughout pregnancy.

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Drugs - Real World Outcomes

Tập 10

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