PREGNANCY OUTCOME FOLLOWING 1ST-TRIMESTER EXPOSURE TO FLUOXETINE (PROZAC)

Objective.- To compare pregnancy outcome following first-trimester flu oxetine (Prozac) exposure with pregnancy outcome in two matched contro l groups. Fluoxetine is a new antidepressant used by many young women. Currently, no published data exist on its safety in pregnancy. Design .-We prospectively collected and followed up 128 pregnant women expose d to a mean daily dose of 25.8 mg (+/- 13 mg) of fluoxetine during the first trimester and compared pregnancy outcome with two matched group s of women exposed during the first trimester of pregnancy to either n onteratogens or tricyclic antidepressants. Results.-Rates of major mal formations were comparable within the three groups and did not exceed those expected in the general population. Women treated with fluoxetin e had a tendency for increased risk for miscarriage when compared with women exposed to nonteratogens (relative risk, 1.9; 95% confidence in terval, 0.92 to 3.92). The rate of miscarriages in the fluoxetine grou p was comparable with the tricyclic group (13.5% and 12.2% vs 6.8% in the nonteratogens). Conclusions.-Our study suggests that the use of fl uoxetine during embryogenesis is not associated with an increased risk of major malformations. Women exposed to both fluoxetine and tricycli c antidepressants tended to report higher rates of miscarriage; furthe r studies will be needed to confirm this observation and to separate t he effects of the psychiatric condition from the associated drugs. Lon g-term studies will be warranted to rule out potential developmental t eratology of fluoxetine, which affects a central nervous system neurot ransmitter.