Changes in adverse events reported by patients during 6 months of fluoxetine therapy.
BACKGROUND
Although a period of 6 to 12 months of antidepressant therapy is recommended for most patients with depression, systematic examinations of the course of adverse events over time, the resolution of early-onset events, and the possible emergence of later-onset events are limited. We examined the safety of fluoxetine, 20 mg/day, in a large, prospective, long-term treatment trial, and we report a comparison of early- and late-onset adverse events and the course of adverse events over 26 weeks of treatment.


METHODS
Adverse events were recorded at each visit in a uniform format by open-ended questioning, regardless of perceived causality. New or worsened events reported in either the first 4 weeks of treatment (early-reporting interval) or weeks 22 through 26 of treatment (late-reporting interval) were compared.


RESULTS
Patients (N = 299) whose depression (DSM-III-R) remitted with 12 weeks of fluoxetine treatment entered continuation therapy, and 174 completed 26 weeks of therapy. All events that occurred in > or =5% of patients early in treatment decreased in frequency over time (p<.05), and no events occurred significantly more frequently during continuation therapy. No previously uncommon adverse events became common during long-term treatment.


CONCLUSIONS
Common adverse events associated with initiating fluoxetine treatment in depressed patients, including nausea, insomnia, nervousness, and somnolence, resolve in the majority of patients and become significantly less frequent with continued treatment over a 6-month period. No adverse events present initially become more frequent late in treatment. Therapy with fluoxetine, 20 mg/day, is well tolerated over 6 months, and most adverse events observed early in treatment resolve.
Department of Psychiatry, Rush Medical Center and Presbyterian-St. Luke's Medical Center, Chicago, Ill, USA.
J
J
Zajecka
J D
JD
Amsterdam
F M
FM
Quitkin
F W
FW
Reimherr
J F
JF
Rosenbaum
R N
RN
Tamura
K L
KL
Sundell
D
D
Michelson
C M
CM
Beasley
D001007:Anxiety / Q000139:chemically induced / Q000453:epidemiology; D003866:Depressive Disorder / Q000188:drug therapy* / Q000523:psychology; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D005473:Fluoxetine / Q000009:adverse effects* / Q000627:therapeutic use; D005500:Follow-Up Studies; D006261:Headache / Q000139:chemically induced / Q000453:epidemiology; D006801:Humans; D009325:Nausea / Q000139:chemically induced / Q000453:epidemiology; D010919:Placebos; D055502:Secondary Prevention; D017367:Selective Serotonin Reuptake Inhibitors / Q000009:adverse effects* / Q000627:therapeutic use; D007319:Sleep Initiation and Maintenance Disorders / Q000139:chemically induced / Q000453:epidemiology; D012894:Sleep Stages; D011795:Surveys and Questionnaires; D016896:Treatment Outcome
D005473:Fluoxetine; D010919:Placebos; D017367:Selective Serotonin Reuptake Inhibitors