Hostname: page-component-848d4c4894-hfldf Total loading time: 0 Render date: 2024-06-07T17:27:40.834Z Has data issue: false hasContentIssue false
  • English
  • Français

Prescription-Event Monitoring of 10401 Patients Treated with Fluvoxamine

Published online by Cambridge University Press:  02 January 2018

J. Guy Edwards ,
William H. W. Inman ,
Lynda Wilton  and
Gillian L. Pearce
J. Guy Edwards*
Affiliation:
University Department of Psychiatry, Royal South Hants Hospital, Southampton SO9 4PE
William H. W. Inman
Affiliation:
Drug Safety Research Unit, Bursledon Hall, Southampton SO3 8BA, UK
Lynda Wilton
Affiliation:
Drug Safety Research Unit, Bursledon Hall, Southampton SO3 8BA, UK
Gillian L. Pearce
Affiliation:
Drug Safety Research Unit, Bursledon Hall, Southampton SO3 8BA, UK
*
∗Correspondence
Get access Rights & Permissions [Opens in a new window]

Abstract

Prescription-event monitoring (PEM) is one of two national systems of drug safety monitoring practised in Britain. The objective of this PEM study was to assess the safety of fluvoxamine and to monitor the occurrence of untoward and other events during treatment. A total of 10 401 patients treated with the drug in general practices throughout England were studied and data were analysed in the Drug Safety Research Unit, Southampton. The main outcome measures were the overall incidence of events per 1000 patients; the incidence during the first month of treatment; the mean incidence for months 2–6 of treatment; and the ratio of these rates as a signal that an event could be drug related. The most commonly reported category of events was neuropsychiatric while the most commonly reported individual events were nausea and vomiting. Fluvoxamine was shown to be a safe drug and no unexpected or previously undetected drug-related events were encountered. There was a relatively high incidence of gastro-intestinal symptoms, but other adverse reactions often encountered during treatment with tricyclic antidepressants were not frequently reported.

Type
Peer Review
Information
The British Journal of Psychiatry , Volume 164 , Issue 3 , March 1994 , pp. 387 - 395
Copyright
Copyright © 1994 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.)

References

Abell, C. A., Farquhar, D. L., Galloway, S. M., et al (1986) Placebo controlled double-blind trial of fluvoxamine maleate in the obese. Journal of Psychosomatic Research, 30, 143–146.CrossRefGoogle ScholarPubMed
Amin, M. M., Ananth, J. V., Coleman, B. S., et al (1984) Fluvoxamine: antidepressant effects confirmed in a placebo-controlled international study. Clinical Neuropharmacology, 7 (suppl. 1), S312–S319.CrossRefGoogle Scholar
Angst, J. (1987) Switch from depression to mania, or from mania to depression. Journal of Psychopharmacology, 1, 13–19.CrossRefGoogle ScholarPubMed
Anonymous (1988) Fluvoxamine (Faverin): another antidepressive drug. Drug and Therapeutics Bulletin, 26, 11–12.CrossRefGoogle Scholar
Balter, M. B., Manheimer, D. I., Mellinger, G. D. & Uhlenhuth, E. H. (1984) A cross-national comparison of anti-anxiety/sedative use. Current Medical Research and Opinion, (suppl. 4), 5–20.Google Scholar
Bamrah, J. S., Benbow, S. M. & McKenna, J. (1990) Fluvoxamine and liver enzymes. British Journal of Psychiatry, 156, 286–287.CrossRefGoogle ScholarPubMed
Banerjee, A. K. (1988) Recovery from prolonged cerebral depression after fluvoxamine overdose. British Medical Journal, 296, 1774.CrossRefGoogle ScholarPubMed
Benfield, P. & Ward, A. (1986) Fluvoxamine. A review of its pharmacodynamic and pharmacokinetic properties, and therapeutic efficacy in depressive illness. Drugs, 32, 313–334.CrossRefGoogle ScholarPubMed
Boyer, W. F. & Feighner, J. P. (1991) Side-effects of the selective serotonin re-uptake inhibitors. In Selective Serotonin Re-uptake Inhibitors (eds J. P. Feighner & W. F. Boyer), pp. 133–152. Chichester: John Wiley & Sons.Google Scholar
Burton, S. W. (1991) A review of fluvoxamine and its uses in depression. International Clinical Psychopharmacology, 6 (suppl. 3), 1–17.CrossRefGoogle ScholarPubMed
Cassano, G. B., Conti, L., Massimetti, G., et al (1986) Use of a standardised documentation system (BLIPS/BDP) in the conduct of a multicenter international trial comparing fluvoxamine, imipramine and placebo. Psychopharmacology Bulletin, 22, 52–58.Google ScholarPubMed
Claassen, V. (1983) Review of the animal pharmacology and pharmacokinetics of fluvoxamine. British Journal of Clinical Pharmacology, 15, 349S–355S.CrossRefGoogle ScholarPubMed
Claassen, V. Davies, J. E., Herrting, G., et al (1977) Fluvoxamine, a specific 5-hydroxytryptamine uptake inhibitor. British Journal of Pharmacology, 60, 505–516.CrossRefGoogle ScholarPubMed
Edwards, J. G. (1981) Unwanted effects of psychotropic drugs and their mechanisms. In Handbook of Biological Psychiatry, Part VI. Practical Applications of Psychotropic Drugs and Other Biological Treatments (eds H. M. van Praag, M. H. Lader, O. J. Raphaelson & E. J. Sachar), pp. 1–38. New York: Marcel Dekker.Google Scholar
Edwards, J. G. (1992) Selective serotonin reuptake inhibitors. A modest though welcome advance in the treatment of depression. British Medical Journal, 304, 1644–1646.CrossRefGoogle Scholar
Edwards, J. G., Inman, W. H. W., Pearce, G. I. & Rawson, N. S. B. (1991) Prescription-event monitoring of 10,895 patients treated with alprazolam. British Journal of Psychiatry, 158, 387–392.CrossRefGoogle Scholar
Edwards, J. G., Long, S. K., Sedgwick, E. M. & Wheal, H. V. (1987) Antidepressants and convulsive seizures: clinical, electroencephalographic and pharmacological aspects. Clinical Neuropharmacology, 9, 329–360.CrossRefGoogle Scholar
Edwards, J. G., & Wheal, H. V. (1992) Assessment of epileptogenic potential: experimental, clinical and epidemiological approaches. Journal of Psychopharmacology, 6, 204–213.CrossRefGoogle ScholarPubMed
Feighner, J. P., Boyer, W. F., Meredith, C. H. & Hendrickson, G. G. (1989) A placebo-controlled inpatient comparison of fluvoxamine maleate and imipramine in major depression. International Clinical Psychopharmacology, 4, 239–244.CrossRefGoogle ScholarPubMed
Geukes-Foppen, F. H., Papworth, S. J. & Peck, A. W. (1983) Fluvoxamine. A novel 5-HT re-uptake inhibitor for the treatment of depression. British Journal of Clinical Pharmacology, 15 (suppl. 3), 347S–449S.Google Scholar
Green, B. H. (1988) Fluvoxamine and hepatic function. British Journal of Psychiatry, 153, 130–131.CrossRefGoogle ScholarPubMed
Guelfi, J. D., Dreyfus, J. F., Pichot, P., et al (1983) A double-blind controlled clinical trial comparing fluvoxamine with imipramine. British Journal of Clinical Pharmacology, 15 (suppl. 3), 411S–417S.CrossRefGoogle ScholarPubMed
Guy, W., Wilson, W. H., Ban, T. A., et al (1984) A double-blind clinical trial of fluvoxamine and imipramine in patients with primary depression. Drug Development Research, 4, 143–153.CrossRefGoogle Scholar
Hamilton, B. A., Jones, P. G., Hoda, A. N., et al (1989) Flupenthixol and fluvoxamine in mild to moderate depression: a comparison in general practice. Pharmatherapeutica, 5, 292–297.Google ScholarPubMed
Harris, B. & Ashford, J. (1991) Maintenance antidepressants and weight gain: a comparison of fluvoxamine and amitriptyline. British Journal of Clinical Research, 2, 81–88.Google Scholar
Henry, J. A. (1991) Overdose and safety with fluvoxamine. International Clinical Psychopharmacology, 6 (suppl. 3), 41–45.CrossRefGoogle ScholarPubMed
Holm, E. & Stamm, W. U. S. (1986) Safety of fluvoxamine for patients with chronic liver disease. Biochemical variables, psychometric performance, and ECG. Advances in Pharmacotherapy, 2, 151–165.Google Scholar
Holm, E., Jacob, S., Kortsik, C., et al (1988) Failure of selective serotonin re-uptake inhibition to worsen the mental state of patients with subclinical hepatic encephalopathy. In Advances in Ammonia Metabolism and Hepatic Encephalopathy (eds P. B. Soeters, J. H. P. Wilson, A J. Meijer & E. Holm), pp. 474–486. Amsterdam: Excerpta Medica.Google Scholar
Inman, W. H. W., Rawson, R. S. B. & Wilton, L. V. (1986) Prescription-event monitoring. In Monitoring for Drug Safety, 2nd edn. (ed. Inman, W. H. W.), pp. 213–235. London: MTP Press Ltd.Google Scholar
Itil, T. M., Shrivastava, R. K., Mukherjee, S., et al (1983) A double-blind placebo-controlled study of fluvoxamine and imipramine in out-patients with primary depression. British Journal of Clinical Pharmacology, 15 (suppl. 3), 433S–438S.CrossRefGoogle ScholarPubMed
Klok, C. J., Brouwer, G. J., Van Praag, H. M. & Doogan, D. (1981) Fluvoxamine and clomipramine in depressed patients. A double-blind clinical study. Acta Psychiatrica Scandinavica, 64, 1–11.CrossRefGoogle ScholarPubMed
Lam, K. S., Blanchi, A., & Chavaillon, J. M. (1988) Hepatite probablement secondaire à la prise massive de fluvoxamine. Gastroenterologie Clinique et Biologique, 12, 398–399.Google Scholar
Lapierre, Y. D., Browne, M., Horn, E., et al (1987) Treatment of major affective disorder with fluvoxamine. Journal of Clinical Psychiatry, 48, 65–68.Google ScholarPubMed
Laws, D., Ashford, J. J. & Anstee, J. A. (1990) A multicentre double-blind comparative trial of fluvoxamine versus lorazepam in mixed anxiety and depression treated in general practice. Acta Psychiatrica Scandinavica, 81, 185–189.CrossRefGoogle ScholarPubMed
Manth, S. M. & Prager, G. (1987) Fluvoxamin bei kardialen Risikopatienten. Advances in Pharmacotherapy, 3, 36–46.Google Scholar
March, J. S., Kobak, K. A., Jefferson, J. W., et al (1990) A double-blind, placebo-controlled trial of fluvoxamine versus imipramine in outpatients with major depression. Journal of Clinical Psychiatry, 51, 200–202.Google ScholarPubMed
Martin, A. J., Tebbs, V. M. & Ashford, J. J. (1987) Affective disorders in general practice. Treatment of 6,000 patients with fluvoxamine. Pharmacatherapeutica, 5, 40–49.Google Scholar
Mullin, J. M., Pandita-Gunawardena, V. R. & Whitehead, A. M. (1988) A double-blind comparison of fluvoxamine and dothiepin in the treatment of major effective disorder. British Journal of Clinical Practice, 42, 51–55.Google Scholar
Prager, G., Cimander, K., Wagner, W., et al (1986) The cardiotropic effect of antidepressants. A comparison with fluvoxamine. Advances in Pharmacotherapy, 2, 133–150.Google Scholar
Rawson, N. S. B., Pearce, G. L. & Inman, W. H. W. (1990) Prescription-event monitoring: methodology and recent progress. Journal of Clinical Epidemiology, 43, 509–522.CrossRefGoogle ScholarPubMed
Robinson, J. F. & Doogan, D. P. (1982) A placebo controlled study of the cardiovascular effects of fluvoxamine and clovoxamine in human volunteers. British Journal of Clinical Pharmacology, 14, 805–808.CrossRefGoogle ScholarPubMed
Shepherd, M., Cooper, B., Brown, A. C., et al (1981) Psychiatric Illness in General Practice, 2nd edn. Oxford: Oxford University Press.Google Scholar
Soloman, R. L., Rich, C. L. & Darko, D. F. (1990) Antidepressant treatment and the occurrence of mania in bipolar patients admitted for depression. Journal of Affective Disorders, 18, 253–257.CrossRefGoogle Scholar
Tebbs, V. M. & Martin, A. J. (1987) Affective disorders in the elderly: 1,000 patient GP trial on new drug. Geriatric Medicine, 17, 17–21.Google Scholar
Teicher, M. T., Glod, C. & Cole, J. O. (1990) Emergence of intense suicidal preoccupation during fluoxetine treatment. American Journal of Psychiatry, 147, 207–210.Google ScholarPubMed
Trimble, M. R. (1978) Non-monoamine oxidase inhibitor antidepressants and epilepsy. A review. Epilepsia, 19, 241–250.CrossRefGoogle ScholarPubMed
Wagner, W., Plekkenpol, B., Gray, T. E., et al (1992) Review of fluvoxamine safety database. Drugs, 43 (suppl. 2), 48–54.CrossRefGoogle ScholarPubMed
Weissman, M. M. & Klerman, G. L. (1977) Sex differences and the epidemiology of depression. Archives of General Psychiatry, 34, 98–111.CrossRefGoogle ScholarPubMed
Weissman, M. M. & Klerman, G. L. (1985) Gender and depression. Trends in the Neurosciences, 8, 416–420.CrossRefGoogle Scholar
Wilson, W. H., Higano, H., Papadatos, Y., et al (1983) A double-blind placebo-controlled study to compare the autonomic effects of fluvoxamine with those of amitriptyline and doxepin in healthy volunteers. British Journal of Clinical Pharmacology, 15 (suppl. 3), 385S–392S.CrossRefGoogle ScholarPubMed
Submit a response

eLetters

No eLetters have been published for this article.