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Evaluating suicide-related adverse events in clinical trials of fluoxetine treatment in adults for indications other than major depressive disorder

Published online by Cambridge University Press:  20 July 2007

SITRA TAUSCHER-WISNIEWSKI ,
DAMON DISCH ,
JOHN PLEWES ,
SUSAN BALL  and
CHARLES M. BEASLEY Jr
SITRA TAUSCHER-WISNIEWSKI*
Affiliation:
Eli Lilly and Company, Indianapolis, Indiana, USA Medical University of Vienna, Vienna, Austria
DAMON DISCH
Affiliation:
Eli Lilly and Company, Indianapolis, Indiana, USA
JOHN PLEWES
Affiliation:
Eli Lilly and Company, Indianapolis, Indiana, USA
SUSAN BALL
Affiliation:
Eli Lilly and Company, Indianapolis, Indiana, USA
CHARLES M. BEASLEY Jr
Affiliation:
Eli Lilly and Company, Indianapolis, Indiana, USA
*
*Address for correspondence: Sitra Tauscher-Wisniewski, M.D., Eli Lilly and Company, Drop Code 1730, Indianapolis, IN46285, USA.  (Email: [email protected])
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Abstract

Background

The association between treatment-emergent suicidality as an adverse event and fluoxetine treatment was examined using a fluoxetine double-blind placebo-controlled database of clinical trials for indications other than major depressive disorder.

Method

The database consisted of 53 trials for 16 different indications (14 psychiatric, two non-psychiatric). Within each study, patient adverse event reports and narratives were searched extensively for treatment-emergent thoughts and behaviors associated with suicide. The incidence of adverse events was classified using Food and Drug Administration (FDA) codes for completed suicide, preparatory acts, suicidal ideation and the summary category of ‘all suicidality.’ The risk difference and risk ratios between fluoxetine and placebo treatment arms were compared using Mantel–Haenszel methods.

Results

Within this large database, patients were randomly assigned to receive treatment with either fluoxetine (n=7066) or placebo (n=4382). Treatment groups did not differ in their risk for the emergence of suicidality for any FDA code; the risk ratio for ‘all suicidality’ was 0·82 (p=0·406), and there were no completed suicides in either group. Analyses based on treatment indication (bulimia, obsessive-compulsive disorder, other psychiatric and non-psychiatric illness) also showed no significant difference in risk between treatment groups. When examined by age categories (18–24, 25–30, 31–65, and ⩾65 years), fluoxetine and placebo treatments did not result in significant risk difference for the emergence of suicidality.

Conclusions

The risk of treatment-emergent suicidality does not appear to be associated with fluoxetine treatment for adults with various non-MDD conditions.

Type
Original Article
Information
Psychological Medicine , Volume 37 , Issue 11 , November 2007 , pp. 1585 - 1593
Copyright
Copyright © Cambridge University Press 2007

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