Pregnancy outcome following first trimester maternal exposure to the newer selective serotonin reuptake inhibitors

grantor: University of TorontoThe main objective of this study was to determine if first trimester use of the newer selective serotonin reuptake inhibitors (SSRIs), fluvoxamine, paroxetine and/or sertraline increases the baseline risk of having a child with a major malformation. The secondary outcomes of interest were pregnancy outcome, gestational age and birth weight. Women who called a participating teratogen information service regarding first trimester use of one of the above SSRIs were contacted at a later date to ascertain pregnancy outcome. These women were compared to a control group consisting of women not exposed to any known human teratogen in their pregnancy. A total of 267 exposed women were followed up: 26 women used fluvoxamine, 97 women used paroxetine, and 147 women used sertraline (1 woman used both fluvoxamine and sertraline, and 2 women used both paroxetine and sertraline). There.were 9 liveborn infants with major malformations in the exposed group and 9 in the control group (p = 0.91). The number of live births in the exposed group were 222 versus 235 in the control group (p = 0.14). There was no difference in either birth weights (3439 g in the exposed group, 3445 g in the control group, p = 0.91) or gestational age (39.4 weeks in the exposed group, 39.4 weeks in the control group, p = 0.71). These results do not suggest an associated increase in risk of major malformations. Although reassuring, a larger study is required to definitively label these drugs as safe for use in pregnancy.M.Sc