| Title | Dexfenfluramine and fenfluramine adverse effects on heart valves: the role of pharmacovigilance | |
| Authors | Slobodan M. Jankovic¹, Vassiliki Mirtsou-Fidani² and Dimitrios Kouvelas²
1. Center for Clinical and Experimental Pharmacology, Clinical Hospital Center Kragujevac, Kragujevac, Serbia, Yugoslavia 2. Department of Pharmacology, Medical Faculty, Aristotle University, Thessaloniki, Greece |
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| Citation | Jankovic, S.M., Mirtsou-Fidani, V., Kouvelas, D.: Dexfenfluramine and fenfluramine adverse effects on heart valves: the role of pharmacovigilance, Epitheorese Klin. Farmakol. Farmakokinet. 14(1): 28-31 (2000) | |
| Publication Date | Received for publication: 5 January 2000
Accepted for publication: 15 January 2000 |
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| Full Text Language | English | |
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| Keywords | Fenfluramine, heart valve disease, pharmacovigilance, spontaneous reporting, adverse effects. | |
| Other Terms | review article | |
| Summary | The rare adverse effects of types B and C are likely to be revealed only after the drug was approved and widely prescribed. In the case of fenfluramine/dexfenfluramine it took 24 years to recognise heart valve disease as a consequence of their usage for the treatment of obesity. Only clustering of cases with specific valve disease in major cardiac surgery centre allowed to physicians to establish the link with the drugs usage and to spontaneously report it to regulatory authorities. However, carefully designed pharmacoepidemiological or postmarketing surveillance studies which would take into account pharmacodynamic characteristics of a drug and his belonging to particular drug class, could help to discover rare adverse effects earlier and to minimise risks of new drugs usage. | |
| References | 1. Glaxo Group Research. International Drug Surveillance Department: Drug Safety. A Shared Responsibility, 1st edition, Churchill Livingstone, Edinburgh, 1991
2. Meyboom R.H., Egberts A.C., Edwards I.R., Hekster Y.A., de Koning F.H., Gribnau F.W.: Principles of signal detection in pharmacovigilance. Drug. Saf. 16: 355-65 (1997) 3. Connolly H.M., Crary, J.L., McGoon M.D., Hensrud D.D., Edwards B.S., Edwards W.D., Schaff H.V.: Valvular heart disease associated with fenfluramine-phentermine. N. Engl. J. Med. 337: 581-8(1997) 4. Food and Drug Administration: Health advisory on fenfluramine/phentermine for obesity. July 8, 1997 5. FDA Center for Drug Evaluation and Research.: “Fen-phen” Information (fenfluramine, phentermine, dexfenfluramine), 1997 6. Weissman N.J., Tighe J.F., Gottdiener J.S., Gwynne J.T.: An assessment of heart valve abnormalities in obese patients taking dexfenfluramine, sustained release dexfenfluramine or placebo. Sustained-Release Dexfenfluramine Study Group. N. Engl. J. Med. 339: 725-32 (1998) 7. Food and Drug Administration: FDA announces withdrawal of fenfluramine and dexfenfluramine. September 15, 1997 8. Food and Drug Administration: Interim recommendations issued for patients exposed to fenfluramine and dexfenfluramine. November 13, 1997 9. World Health Organization: Alert No. 63. Fenfluramine and dexfenfluramine withdrawn: cardiotoxicity (USA). 16 September 1997 10. Meyboom, R.H., Hekster, Y.A., Egberts, A.C., Gribnau, F.W., Edwards, I.R.: Causal or casual? The role of causality assessment in pharmacovigilance. Drug, Saf. 17: 374-89 (1997) 11. Anonymous: Study Finds Low Rate Of Heart Valve Disease Among Phen-Fen Users. Journal of the American College of Cardiology/MedscapeWire, October 1, 1999 |
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| Relative Papers |
Online ISSN 1011-6575
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Articles published in this Journal are Indexed or Abstracted in: • Chemical Abstracts • Elsevier’s Bibliographic Databases: Scopus, EMBASE, EMBiology, Elsevier BIOBASE SCImago Journal and Country Rank Factor
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