Hostname: page-component-669899f699-ggqkh Total loading time: 0 Render date: 2025-04-29T10:08:38.032Z Has data issue: false hasContentIssue false
  • English
  • Français

The Safety of Fluoxetine - An Update

Published online by Cambridge University Press:  06 August 2018

Glenn L. Cooper
Glenn L. Cooper*
Affiliation:
Europe, Lilly Research Centre Limited, Windlesham, Surrey, UK
Get access Rights & Permissions [Opens in a new window]

Extract

Fluoxetine is a new antidepressant agent which is a selective inhibitor of neuronal serotonin uptake; it has minimal affinity for muscarinic, dopaminergic, histaminic, serotonergic, or noradrenergic receptors (Stark et al, 1985). This specificity of activity suggests that fluoxetine may have a side-effect profile which is different from previously available antidepressants.

The safety of fluoxetine has been extensively studied: several hundred patients have received the drug continuously for more than one year - some have had therapy for 5 years or more. Previous reviews of the safety of fluoxetine (Wernicke, 1985; Zerbe, 1986) have described a smaller population of patients than is now available.

This review is drawn from data pooled from comparative clinical trials, which included 4336 patients: fluoxetine - 2938, tricyclic antidepressants (TCAs) - 599, and placebo - 799 patients. The TCAs studied were amitriptyline, imipramine, and doxepin. Most patients were adults with major depressive disorder, and the most common study design was a 6-week comparative double-blind phase, followed by unblinded long-term treatment. While the core of this study is a data base of 2938 fluoxetine-treated patients, all serious adverse events reported in over 7500 fluoxetine-treated patients worldwide, as of mid-1987, have been included.

Type
Research Article
Information
The British Journal of Psychiatry , Volume 153 , Issue S3: Progress in Antidepressant Therapy , September 1988 , pp. 77 - 86
Copyright
Copyright © 1988 The Royal College of Psychiatrists 

Access options

Get access to the full version of this content by using one of the access options below. (Log in options will check for institutional or personal access. Content may require purchase if you do not have access.)

Article purchase

Temporarily unavailable

References

Bonney, W. E. (1978) Psychopharmacology of the switch process in affective illness. In Psychopharmacology: A Generation of Progress (eds Lipton, M. A., DiMascio, A. & Killam, K. F.). New York: Raven Press.Google Scholar
Brophy, G. T., Lake, S. G. & Griffing, W. J. et al (1983) Reversible phospholipidosis associated with fluoxetine administration in the mouse, rat and dog. Toxicology Letters, 18 (Suppl. 1), 143.CrossRefGoogle Scholar
Committee on Safety of Medicines (United Kingdom) (1983) Zimelidine (zelmid). Current Problems, 11, 1.Google Scholar
Chouinard, G. & Jones, B. (1984) No cross-over hypersensitivity between zimelidine and fluoxetine. Canadian Medical Association Journal, 131, 1190.Google Scholar
Crome, P. & Newman, B. (1979) The problem of tricyclic antidepressant poisoning. Postgraduate Medical Journal, 55, 528–532.Google Scholar
Fisch, C. (1985) Effect of fluoxetine on the electrocardiogram. Journal of Clinical Psychiatry, 46, 42–44.Google Scholar
Hawthorne, J. W., Marcus, A. M. & Kaye, M. (1983) Management of massive imipramine overdosage with mannitol and artificial dialysis. New England Journal of Medicine, 268, 33–35.Google Scholar
Hindmarch, I. (1986) Antidepressants taken with and without alcohol compared on tests of psychomotor ability related to car driving. 15th Collegium Internationale Neuro-Psychopharmaco-logicum Congress, Abstract No. 249.Google Scholar
Hollister, L. E. (1978) Treatment of depression with drugs. Annals of Internal Medicine, 89, 78–84.CrossRefGoogle ScholarPubMed
Lemberger, L., Bergstrom, R. F. & Wolen, R. L. et al (1985) Fluoxetine: clinical pharmacology and physiologic disposition. Journal of Clinical Psychiatry, 46, 14–19.Google Scholar
Lewis, J. L. & Winokur, G. (1982) The induction of mania. Archives of General Psychiatry, 39, 303–307.Google Scholar
Lüllman-Rauch, R. (1979) Drug-induced lysosomal storage disorders in lysosomes. In Applied Biology and Therapeutics (eds Dingle, J. T., Jacques, P. J. & Shaw, I. H.), Vol. 6. Amsterdam: North Holland.Google Scholar
Lüllman-Rauch, R. & Schied, D. (1975) Intraalveolar foam cells associated with lipidosis-like alterations in lung and liver of rats treated with tricyclic psychotropic drugs. Virchows Archives (Cell Pathology), 19, 255–268.CrossRefGoogle Scholar
Nasrallah, H. A., Lyskowski, J. & Schroeder, D. (1982) TCA-induced mania: differences between switches and non-switches. Biological Psychiatry, 17, 271–274.Google Scholar
Nilsson, B. S. (1983) Adverse reactions in connection with zimelidine treatment - a review. Acta Psychiatrica Scandinavia, 681 (Suppl. 308), 115–119.CrossRefGoogle Scholar
Rasmussen, J. (1985) Amitriptyline and imipramine poisoning. The Lancet, ii, 850–851.Google Scholar
Reasor, M. J. (1981) Drug-induced lipidosis and the alveolor macrophage. Toxicology, 20, 1–33.Google Scholar
Schaffler, K. (1986) Study on performance and alcohol interaction with the antidepressant fluoxetine - a selective serotonin reuptake inhibitor - using computer assisted psychophysiological methodology. British Journal of Clinical Practice, 40 (Suppl. 46), 28–33.Google Scholar
Sommerville, J. M., McLaren, E. H. & Cambell, L. M. et al (1982) Severe headache and disturbed liver function during treatment with zimelidine. British Medical Journal, 285, 1009.Google Scholar
Stark, P., Fuller, R. W. & Wong, D. T. (1985) The pharmacologic profile of fluoxetine. Journal of Clinical Psychiatry, 46, 7–13.Google Scholar
Steiner, W. & Fontaine, R. (1986) Toxic reaction following the combined administration of fluoxetine and l-tryptophan: five case reports. Biological Psychiatry, 21, 1067–1071.Google Scholar
Wernicke, J. F. (1985) The side-effect profile and safety of fluoxetine. Journal of Clinical Psychiatry, 46, 59–67.Google Scholar
Wernicke, J. F. & Bremmer, J. D. (1986) Fluoxetine effective in the long-term treatment of depression. British Journal of Clinical Practice, 40 (Suppl. 46), 17–23.Google Scholar
Wernicke, J. F. & Dunlop, S. (1987) Fixed-dose fluoxetine therapy for depression. Psychopharmacology Bulletin, 23, 164–168.Google ScholarPubMed
Wernicke, J. F., Dornsief, B. E. & Zerbe, R. L. (1986) Fluoxetine is effective in the treatment of depression at low fixed doses. 15th Collegium Internationale Neuro-Psychopharmacologicum Congress, Abstract No. 222.Google Scholar
Williams, R. B. & Sherter, L. (1971) Cardiac complications of tricyclic antidepressant therapy. Annals of Internal Medicine, 74, 395–398.Google Scholar
Zerbe, R. L. (1986) Safety of fluoxetine. British Journal of Clinical Practice, 40 (Suppl. 46), 41–47.Google Scholar
Submit a response

eLetters

No eLetters have been published for this article.