title: Pregnancy outcome following first-trimester exposure to fluoxetine (Prozac)
abstract: OBJECTIVE
  To compare pregnancy outcome following first-trimester fluoxetine (Prozac) exposure with pregnancy outcome in two matched control groups. Fluoxetine is a new antidepressant used by many young women. Currently, no published data exist on its safety in pregnancy.
  
  
  METHODS
  We prospectively collected and followed up 128 pregnant women exposed to a mean daily dose of 25.8 mg (+/- 13 mg) of fluoxetine during the first trimester and compared pregnancy outcome with two matched groups of women exposed during the first trimester of pregnancy to either nonteratogens or tricyclic antidepressants.
  
  
  RESULTS
  Rates of major malformations were comparable within the three groups and did not exceed those expected in the general population. Women treated with fluoxetine had a tendency for increased risk for miscarriage when compared with women exposed to nonteratogens (relative risk, 1.9; 95% confidence interval, 0.92 to 3.92). The rate of miscarriages in the fluoxetine group 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 fluoxetine during embryogenesis is not associated with an increased risk of major malformations. Women exposed to both fluoxetine and tricyclic antidepressants tended to report higher rates of miscarriage; further studies will be needed to confirm this observation and to separate the effects of the psychiatric condition from the associated drugs. Long-term studies will be warranted to rule out potential developmental teratology of fluoxetine, which affects a central nervous system neurotransmitter.
authors: Motherisk Program, Hospital for Sick Children, Toronto, Ontario, Canada.
authors: A
authors: A
authors: Pastuszak
authors: B
authors: B
authors: Schick-Boschetto
authors: C
authors: C
authors: Zuber
authors: M
authors: M
authors: Feldkamp
authors: M
authors: M
authors: Pinelli
authors: S
authors: S
authors: Sihn
authors: A
authors: A
authors: Donnenfeld
authors: M
authors: M
authors: McCormack
authors: M
authors: M
authors: Leen-Mitchell
authors: C
authors: C
authors: Woodland
mesh_terms: D000929:Antidepressive Agents, Tricyclic / Q000009:adverse effects / Q000627:therapeutic use; D005260:Female; D005473:Fluoxetine / Q000009:adverse effects* / Q000627:therapeutic use; D006801:Humans; D011247:Pregnancy; D011256:Pregnancy Outcome; D011261:Pregnancy Trimester, First; D011446:Prospective Studies
chemical_list: D000929:Antidepressive Agents, Tricyclic; D005473:Fluoxetine