Tolerability of fluoxetine in posttraumatic stress disorder.
OBJECTIVE
In response to earlier reports that raised concerns about the tolerability of fluoxetine in the treatment of posttraumatic stress disorder (PTSD), this study was conducted to systematically delineate treatment-emergent symptoms (TES) associated with fluoxetine treatment of PTSD.


METHODS
Sixty-five patients with PTSD enrolled in one of two identical-protocol, 12-week studies and received double-blind fluoxetine or placebo. TES data were obtained using a patient-rated checklist, Severity of Symptoms Scale (SOSS).


RESULTS
Only a single patient discontinued treatment due to medication side effects. Compared to placebo, only three statistically significant TES (nausea, diarrhea, and thirst) occurred more frequently in fluoxetine subjects. Fluoxetine was not associated with any statistically significant activating effects. There were no statistically significant associations between the total number of TES experienced and treatment, gender, or comorbid depressive or panic disorders.


CONCLUSIONS
This systematic assessment of TES indicated that PTSD patients tolerated fluoxetine well without pronounced activating side effects.
Barnett
Stewart D
SD
Department of Psychiatry and Behavioral Sciences, Duke University Medical Center, Durham, NC 27710, USA. libsdb@bellsouth.net
Tharwani
Haresh M
HM
Hertzberg
Michael A
MA
Sutherland
Suzanne M
SM
Connor
Kathryn M
KM
Davidson
Jonathan R T
JR
D000284:Administration, Oral; D016009:Chi-Square Distribution; D004311:Double-Blind Method; D005260:Female; D005473:Fluoxetine / Q000009:adverse effects* / Q000627:therapeutic use*; D006801:Humans; D008297:Male; D017367:Selective Serotonin Reuptake Inhibitors / Q000009:adverse effects* / Q000627:therapeutic use*; D018709:Statistics, Nonparametric; D013313:Stress Disorders, Post-Traumatic / Q000188:drug therapy* / Q000523:psychology; D016312:Treatment Refusal
D005473:Fluoxetine; D017367:Selective Serotonin Reuptake Inhibitors