TY - JOUR

T1 - Duloxetine Exposure During Pregnancy and the Risk of Spontaneous and Elective Abortion

T2 - A Danish Nationwide Observational Study

AU - Ankarfeldt, Mikkel Zoellner

AU - Petersen, Janne

AU - Andersen, Jon Traerup

AU - Fernandes, Maria Fernanda Scantamburlo

AU - Li, Hu

AU - Motsko, Stephen Paul

AU - Fast, Thomas

AU - Jimenez-Solem, Espen

PY - 2021

Y1 - 2021

N2 - Background Depression and antidepressant treatment are widespread among women of childbearing age. Objective This study evaluates the association between duloxetine exposure during pregnancy and spontaneous and elective abortions. Patients and Methods The nationwide, observational study based on register data from Denmark included women with a recorded pregnancy in the birth register or an abortion in the patient register between 2004 and 2016. Duloxetine-exposed women were compared with (1) duloxetine non-exposed, (2) selective serotonin reuptake inhibitor (SSRI)-exposed, (3) venlafaxine-exposed, and (4) women discontinuing duloxetine before pregnancy. Exposure status was based on records of redeemed prescriptions. Cox regression with adjustments and propensity score matching was applied. Results The data from 1,019,957 pregnancies were used, including 1,212 pregnancies exposed to duloxetine. Duloxetine-exposed women had an increased hazard ratio (HR) for spontaneous abortions compared with SSRI-exposed women: propensity score matched HR 1.25 [95% confidence interval (CI), 1.00-1.57]. No increased hazard was observed for duloxetine-exposed women compared with duloxetine non-exposed: 1.08 (95% CI 0.89-1.31); venlafaxine-exposed: 1.08 (95% CI 0.82-1.41); and duloxetine discontinuers: 0.99 (95% CI 0.76-1.30). An increased HR of elective abortions was observed in duloxetine-exposed women compared to duloxetine non-exposed: 1.41 (95% CI 1.25-1.59); SSRI-exposed: 1.32 (95% CI 1.15-1.51); and duloxetine discontinuers: 1.46 (95% CI 1.23-1.75), but not to venlafaxine-exposed women: 1.09 (95% CI 0.93-1.27). Conclusion There was no increased risk of spontaneous or elective abortion associated with exposure to duloxetine. The increase risk observed for women exposed to duloxetine in comparison with SSRI-exposed for spontaneous and in comparison with all groups (except venlafaxine-exposed) for elective abortion suggested confounding.

AB - Background Depression and antidepressant treatment are widespread among women of childbearing age. Objective This study evaluates the association between duloxetine exposure during pregnancy and spontaneous and elective abortions. Patients and Methods The nationwide, observational study based on register data from Denmark included women with a recorded pregnancy in the birth register or an abortion in the patient register between 2004 and 2016. Duloxetine-exposed women were compared with (1) duloxetine non-exposed, (2) selective serotonin reuptake inhibitor (SSRI)-exposed, (3) venlafaxine-exposed, and (4) women discontinuing duloxetine before pregnancy. Exposure status was based on records of redeemed prescriptions. Cox regression with adjustments and propensity score matching was applied. Results The data from 1,019,957 pregnancies were used, including 1,212 pregnancies exposed to duloxetine. Duloxetine-exposed women had an increased hazard ratio (HR) for spontaneous abortions compared with SSRI-exposed women: propensity score matched HR 1.25 [95% confidence interval (CI), 1.00-1.57]. No increased hazard was observed for duloxetine-exposed women compared with duloxetine non-exposed: 1.08 (95% CI 0.89-1.31); venlafaxine-exposed: 1.08 (95% CI 0.82-1.41); and duloxetine discontinuers: 0.99 (95% CI 0.76-1.30). An increased HR of elective abortions was observed in duloxetine-exposed women compared to duloxetine non-exposed: 1.41 (95% CI 1.25-1.59); SSRI-exposed: 1.32 (95% CI 1.15-1.51); and duloxetine discontinuers: 1.46 (95% CI 1.23-1.75), but not to venlafaxine-exposed women: 1.09 (95% CI 0.93-1.27). Conclusion There was no increased risk of spontaneous or elective abortion associated with exposure to duloxetine. The increase risk observed for women exposed to duloxetine in comparison with SSRI-exposed for spontaneous and in comparison with all groups (except venlafaxine-exposed) for elective abortion suggested confounding.

KW - SEROTONIN-REUPTAKE INHIBITORS

KW - WOMEN

KW - POPULATION

KW - DEPRESSION

KW - ANTIDEPRESSANTS

KW - PREVALENCE

KW - FLUOXETINE

KW - ASSOCIATION

KW - MISCARRIAGE

KW - VALIDATION

U2 - 10.1007/s40801-021-00252-9

DO - 10.1007/s40801-021-00252-9

M3 - Journal article

C2 - 34008161

VL - 8

SP - 289

EP - 299

JO - Drugs - Real World Outcomes

JF - Drugs - Real World Outcomes

SN - 2199-1154

IS - 3

ER -