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Obstet Gynecol. 1997 May;89(5 Pt 1):713-8.

Effects of first-trimester fluoxetine exposure on the newborn.

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  • 1Lilly Research Laboratories, Eli Lilly and Company, Indianapolis, Indiana, USA.

Abstract

OBJECTIVE:

To determine whether first-trimester exposure to fluoxetine, a selective serotonin reuptake inhibitor commonly used to treat depression and obsessive-compulsive disorders, is associated with increased frequency of fetal malformations.

METHODS:

We evaluated outcomes of all pregnancies identified prospectively with confirmed first-trimester fluoxetine exposure contained in the Eli Lilly and Company worldwide fluoxetine pregnancy registry. These outcomes were compared with historic reports of newborn surveys.

RESULTS:

Outcomes were available for 796 pregnancies, 37 from fluoxetine clinical trials and 759 from spontaneous reports. Spontaneous abortions were reported in 110 of the 796 (13.8%) pregnancies. Of the remaining 686, malformations, deformations, and disruptions, including those identified after the perinatal period, were reported in 34 (5.0%). No consistent or recurring pattern of abnormalities was observed.

CONCLUSION:

Based on comparison with historic reports of newborn surveys, it is unlikely that maternal fluoxetine use during the first trimester of pregnancy results in increased risk of fetal malformations.

PMID:
9166307
[PubMed - indexed for MEDLINE]
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