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 -