Document Detail

Effects of first-trimester fluoxetine exposure on the newborn.
MedLine Citation:
PMID:  9166307     Owner:  NLM     Status:  MEDLINE    
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.
D J Goldstein; L A Corbin; K L Sundell
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Publication Detail:
Type:  Journal Article    
Journal Detail:
Title:  Obstetrics and gynecology     Volume:  89     ISSN:  0029-7844     ISO Abbreviation:  Obstet Gynecol     Publication Date:  1997 May 
Date Detail:
Created Date:  1997-06-24     Completed Date:  1997-06-24     Revised Date:  2009-10-26    
Medline Journal Info:
Nlm Unique ID:  0401101     Medline TA:  Obstet Gynecol     Country:  UNITED STATES    
Other Details:
Languages:  eng     Pagination:  713-8     Citation Subset:  AIM; IM    
Lilly Research Laboratories, Eli Lilly and Company, Indianapolis, Indiana, USA.
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MeSH Terms
Abnormalities, Drug-Induced / etiology*
Abortion, Spontaneous / chemically induced
Adverse Drug Reaction Reporting Systems
Antidepressive Agents, Second-Generation / adverse effects*
Fluoxetine / adverse effects*
Infant, Newborn
Maternal-Fetal Exchange*
Pregnancy Outcome
Pregnancy Trimester, First
Prospective Studies
Retrospective Studies
Risk Factors
Serotonin Uptake Inhibitors / adverse effects*
Reg. No./Substance:
0/Antidepressive Agents, Second-Generation; 0/Serotonin Uptake Inhibitors; 54910-89-3/Fluoxetine

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine

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