Spontaneous or elective abortion with duloxetine in pregnancy

Abstract

There does not appear to be an increased risk of spontaneous or elective abortion in women who receive duloxetine during pregnancy, according to study results reported in Drugs Real World Outcomes. The study used register data in Denmark to identify 1019 957 pregnant women who had a hospital contact encounter in 2004–2016. There were women exposed to duloxetine (n=1212), SSRIs (n=18 345) or venlafaxine (n=4908), and women who discontinued duloxetine before pregnancy (n=1418). A total of 1018 745 women were not exposed to duloxetine. For duloxetine-exposed women, there was no significantly increased risk of spontaneous abortion compared with duloxetine-nonexposed women in propensity score-matched cohorts (hazard ratio [HR] 1.08; 95% CI 0.89, 1.31). The authors note that women with depressive disorder are more vulnerable and are likely to have poorer health behavior during pregnancy . . . than women without depression , which may confound the association . There was also no increased risk compared with duloxetine discontinuers (HR 0.99; 0.76, 1.30), which the authors note may be attributable to common characteristics, for example, health behaviour such as illicit drug use and smoking . There was no significantly increased risk compared with venlafaxine-exposed women (HR 1.08; 0.82, 1.41). Although there was a significantly increased risk compared with SSRI-exposed women, (HR 1.25; 1.00, 1.57), the authors note that this could be explained by factors related to the exposure (e.g., confounding by depression severity) . For duloxetine-exposed women, there was no significantly increased risk of elective abortion compared with venlafaxine-exposed women (HR 1.09; 0.93, 1.27). However, there was a significantly increased risk compared with duloxetine-nonexposed women (HR 1.41; 1.25, 1.59), SSRI-exposed women (HR 1.32; 1.15, 1.51) and duloxetine discontinuers (HR 1.46; 1.23, 1.75), which the authors note suggested confounding . It is difficult to investigate the risk of duloxetine alone , note the authors.