메뉴 건너뛰기




Volumn 23, Issue 1, 2010, Pages 153-173

Discovery and management of adverse drug reactions: The nomifensine hypersensitivity syndrome, 1977-1986

Author keywords

CSM; Drug safety; FDA; Pharmaceutical industry; Regulatory agencies

Indexed keywords


EID: 77950531315     PISSN: 0951631X     EISSN: 14774666     Source Type: Journal    
DOI: 10.1093/shm/hkp049     Document Type: Article
Times cited : (5)

References (75)
  • 2
    • 33645558799 scopus 로고    scopus 로고
    • Testing times: The emergence of the practolol disaster and its challenge to British drug regulation in the modern period
    • DOI 10.1093/shm/hkj005
    • Abraham J. and Davis C. 2006, 'Testing Times: The Emergence of the Practolol Disaster and its Challenge to British Drug Regulation in the Modern Period', Social History of Medicine, 19, 127-147 (Pubitemid 43515506)
    • (2006) Social History of Medicine , vol.19 , Issue.1 , pp. 127-147
    • Abraham, J.1    Davis, C.2
  • 3
    • 34548176034 scopus 로고    scopus 로고
    • Deficits, expectations and paradigms in british and american drug safety assessment
    • Abraham J. and Davis C. 2007, 'Deficits, Expectations and Paradigms in British and American Drug Safety Assessment', Science, Technology and Human Values, 32, 399-431.
    • (2007) Science, Technology and Human Values , vol.32 , pp. 399-431
    • Abraham, J.1    Davis, C.2
  • 6
    • 69549129315 scopus 로고
    • Nomifensine UK data sheet change
    • Anon.
    • Anon. 1985, 'Nomifensine UK Data Sheet Change', Scrip: World Pharmaceutical News, 1047, 23.
    • (1985) Scrip: World Pharmaceutical News , vol.1047 , pp. 23
  • 7
    • 20444397469 scopus 로고
    • Hoechst withdraws nomifensine
    • Anon.
    • Anon. 1986a, 'Hoechst Withdraws Nomifensine', Scrip: World Pharmaceutical News, 1072, 22-23
    • (1986) Scrip: World Pharmaceutical News , vol.1072 , pp. 22-23
  • 8
    • 77950537958 scopus 로고
    • New nomifensine UK data sheet
    • Anon.
    • Anon. 1986b, 'New Nomifensine UK Data Sheet', Scrip: World Pharmaceutical News, 1070, 23-24
    • (1986) Scrip: World Pharmaceutical News , vol.1070 , pp. 23-24
  • 9
    • 77950548200 scopus 로고
    • Hoescht agrees to US fine over merital
    • Anon.
    • Anon. 1990, 'Hoescht Agrees to US Fine over Merital', Scrip: World Pharmaceutical News, 1576, 8.
    • (1990) Scrip: World Pharmaceutical News , vol.1576 , pp. 8
  • 10
    • 77950544334 scopus 로고
    • Hoescht settles on US merital
    • Anon.
    • Anon. 1991, 'Hoescht Settles on US Merital', Scrip: World Pharmaceutical News, 1613, 14-15.
    • (1991) Scrip: World Pharmaceutical News , vol.1613 , pp. 14-15
  • 11
    • 77950543368 scopus 로고
    • Adverse Drug Reaction (ADR) moves in Germany
    • Anon.
    • Anon. 1992, 'Adverse Drug Reaction (ADR) moves in Germany', Scrip: World Pharmaceutical News, 1681, 6-7.
    • (1992) Scrip: World Pharmaceutical News , vol.1681 , pp. 6-7
  • 13
    • 0018416262 scopus 로고
    • Nomifensine-induced immune haemolytic anaemia and impaired renal function
    • Bournerias F. and Habibi B. 1979, 'Nomifensine-Induced Immune Haemolytic Anaemia and Impaired Renal Function', Lancet, 14 July, 95-96 (Pubitemid 9223955)
    • (1979) Lancet , vol.2 , Issue.8133 , pp. 95-96
    • Bournerias, F.1    Habibi, B.2
  • 17
    • 84941555070 scopus 로고
    • CSM update: Adverse reactions to antidepressants
    • Committee on Safety of Medicines, 7 December
    • Committee on Safety of Medicines 1985, 'CSM Update: Adverse Reactions to Antidepressants', British Medical Journal, 7 December, 291, 1638.
    • (1985) British Medical Journal , vol.291 , pp. 1638
  • 18
    • 84970796884 scopus 로고
    • CSM update: Withdrawal of nomifensine
    • Committee on Safety of Medicines, 5 July
    • Committee on Safety of Medicines 1986, 'CSM Update:Withdrawal of Nomifensine', British Medical Journal, 5 July, 293, 41.
    • (1986) British Medical Journal , vol.293 , pp. 41
  • 20
    • 0019164937 scopus 로고
    • Koorts en Leverfunctiestoornissen ten Gevolge van Nomifensine
    • Dankbaar H. and Mudde A. H. 1980, 'Koorts en Leverfunctiestoornissen ten Gevolge van Nomifensine', Nederlands Tijdschrift Voor Geneeskunde, 124, 2184-2186
    • (1980) Nederlands Tijdschrift voor Geneeskunde , vol.124 , pp. 2184-2186
    • Dankbaar, H.1    Mudde, A.H.2
  • 22
    • 7844251799 scopus 로고    scopus 로고
    • Withdrawal of psychotropic drugs from the market: II. from nomifensine to remoxipride
    • Hindmarch I. and Stonier P. D. (eds), Chichester: John Wiley and Sons
    • Edwards J. G. 1997, 'Withdrawal of Psychotropic Drugs from the Market: II. From Nomifensine to Remoxipride', in Hindmarch I. and Stonier P. D. (eds), Human Pharmacology. Measures and Methods Volume6, Chichester: John Wiley and Sons, 215-233
    • (1997) Human Pharmacology. Measures and Methods , vol.6 , pp. 215-233
    • Edwards, J.G.1
  • 24
    • 63049130432 scopus 로고    scopus 로고
    • Baltimore: Johns Hopkins University Press
    • Greene J. A. 2007, Prescribing by Numbers, Baltimore: Johns Hopkins University Press.
    • (2007) Prescribing by Numbers
    • Greene, J.A.1
  • 25
  • 26
    • 0012313471 scopus 로고    scopus 로고
    • New York: New York University Press
    • Healy D. 2004, Let Them Eat Prozac, New York: New York University Press.
    • (2004) Let Them Eat Prozac
    • Healy, D.1
  • 32
    • 77950535545 scopus 로고
    • Hoescht-Roussel, (US label), January Edition
    • Hoescht-Roussel 1985a, Merital (US label), January Edition.
    • (1985) Merital
  • 33
    • 77950531451 scopus 로고
    • Hoescht-Roussel, (US label), November Edition
    • Hoescht-Roussel 1985b, Merital (US label), November Edition.
    • (1985) Merital
  • 34
    • 0017717571 scopus 로고
    • A comparative review of the pharmacology of nomifensine
    • Hoffman I. 1977, 'A Comparative Review of the Pharmacology of Nomifensine', British Journal of Clinical Pharmacology, 4, 69S-75S.
    • (1977) British Journal of Clinical Pharmacology , vol.4
    • Hoffman, I.1
  • 36
    • 0037703114 scopus 로고    scopus 로고
    • Hampshire: Highland Park Productions
    • Inman B. 1999, Don't Tell the Patient, Hampshire: Highland Park Productions.
    • (1999) Don't Tell the Patient
    • Inman, B.1
  • 43
    • 0022529037 scopus 로고
    • The under-reporting of adverse drug reactions seen in general practice
    • Lumley C. E., Walker S. R. and Hall G. C. 1986, 'The Under-Reporting of Adverse Drug Reactions Seen in General Practice', Pharmaceutical Medicine, 1, 205-212 (Pubitemid 16079336)
    • (1986) Pharmaceutical Medicine , vol.1 , Issue.3 , pp. 205-212
    • Lumley, C.E.1    Walker, S.R.2    Hall, G.C.3
  • 44
    • 47749102100 scopus 로고    scopus 로고
    • The changing management of acute bronchitis in Britain, 1940-1970
    • MacFarlane J. T. and Worboys M. 2007, 'The Changing Management of Acute Bronchitis in Britain, 1940-1970', Medical History, 52, 47-72.
    • (2007) Medical History , vol.52 , pp. 47-72
    • MacFarlane, J.T.1    Worboys, M.2
  • 45
    • 0024209406 scopus 로고
    • Lessons from nomifensine
    • Mann R. D. 1988, 'Lessons from Nomifensine', The Lancet, 24/31 December, 1490-1491 (Pubitemid 19016678)
    • (1988) Lancet , vol.2 , Issue.8626-8627 , pp. 1490-1491
    • Mann, R.D.1
  • 47
    • 42949140004 scopus 로고    scopus 로고
    • The creation of the concept of an antidepressant
    • Moncrieff J. 2008, 'The Creation of the Concept of an Antidepressant', Social Science and Medicine, 66, 2346-2355
    • (2008) Social Science and Medicine , vol.66 , pp. 2346-2355
    • Moncrieff, J.1
  • 48
    • 69549095735 scopus 로고
    • The nonselective effect of selective antidepressants
    • Costa E. and Racagni G. (eds.), New York: Raven Press
    • Montgomery S. A. 1982, 'The Nonselective Effect of Selective Antidepressants', in Costa E. and Racagni G. (eds.), Typical and Atypical Antidepressants, New York: Raven Press, 48-62.
    • (1982) Typical and Atypical Antidepressants , pp. 48-62
    • Montgomery, S.A.1
  • 49
    • 69549097524 scopus 로고
    • Supersensitivity and nomifensine in depressed patients
    • Costa E. and Racagni G. (eds), New York: Raven Press
    • Montgomery S., Roy D. and Montgomery D. B. 1982, 'Supersensitivity and Nomifensine in Depressed Patients', in Costa E. and Racagni G. (eds), Typical and Atypical Antidepressants, New York: Raven Press, 213-221
    • (1982) Typical and Atypical Antidepressants , pp. 213-221
    • Montgomery, S.1    Roy, D.2    Montgomery, D.B.3
  • 50
    • 0003972703 scopus 로고
    • New York: Simon and Schuster
    • Moore T. J. 1995, Deadly Medicine, New York: Simon and Schuster.
    • (1995) Deadly Medicine
    • Moore, T.J.1
  • 54
    • 77950545435 scopus 로고    scopus 로고
    • Psychopharmacological Drugs Advisory Committee 1979, Transcript, PDAC, FDA, Rockville, Maryland, 15 October
    • Psychopharmacological Drugs Advisory Committee 1979, Transcript, PDAC, FDA, Rockville, Maryland, 15 October.
  • 55
    • 33744758336 scopus 로고    scopus 로고
    • Putting theory into practice: James Black, receptor theory and the development of the beta-blockers at ICI, 1958-1978
    • Quirke V. 2006, 'Putting Theory into Practice: James Black, Receptor Theory and the Development of the Beta-Blockers at ICI, 1958-1978', Medical History, 50, 69-92. (Pubitemid 44874440)
    • (2006) Medical History , vol.50 , Issue.1 , pp. 69-92
    • Quirke, V.1
  • 56
    • 0036631974 scopus 로고    scopus 로고
    • Steroids in arms
    • Rasmussen N. 2002a, 'Steroids in Arms', Medical History, 46, 299-324.
    • (2002) Medical History , vol.46 , pp. 299-324
    • Rasmussen, N.1
  • 57
    • 23944495204 scopus 로고    scopus 로고
    • Of "small men", big science and bigger business
    • Rasmussen N. 2002b, 'Of "Small Men", Big Science and Bigger Business', Minerva, 40, 115-146
    • (2002) Minerva , vol.40 , pp. 115-146
    • Rasmussen, N.1
  • 58
    • 18244373981 scopus 로고    scopus 로고
    • The drug industry and clinical research in interwar America
    • Rasmussen N. 2005, 'The Drug Industry and Clinical Research in Interwar America', Bulletin for the History of Medicine, 79, 50-80.
    • (2005) Bulletin for the History of Medicine , vol.79 , pp. 50-80
    • Rasmussen, N.1
  • 60
    • 0021838250 scopus 로고
    • The role of metabolite-specific antibodies in nomifensine-dependent immune hemolytic anemia
    • Salama A. and Mueller-Eckhardt C. 1985, 'The Role of Metabolite-Specific Antibodies in Nomifensine-Dependent Immune Haemolytic Anaemia', New England Journal of Medicine, 313, 469-474 (Pubitemid 15015074)
    • (1985) New England Journal of Medicine , vol.313 , Issue.8 , pp. 469-474
    • Salama, A.1    Mueller-Eckhardt, C.2
  • 61
    • 0021889578 scopus 로고
    • Fatal immune haemolysis associated with nomifensine
    • Sokol R. J., Hewitt S., Booker D. J., Stamps R. and Taylor M. 1985, 'Fatal Immune Haemolysis Associated with Nomifensine', British Medical Journal, 291, 311. (Pubitemid 15045114)
    • (1985) British Medical Journal , vol.291 , Issue.6491 , pp. 311-312
    • Sokol, R.J.1    Hewitt, S.2    Booker, D.J.3
  • 64
    • 77950548335 scopus 로고
    • Office of Drug Research and Review to Hoescht-Roussel, 31 December
    • Temple R. J. 1984a, FDA Approvable Letter from Director, Office of Drug Research and Review to Hoescht-Roussel, 31 December.
    • (1984) FDA Approvable Letter from Director
    • Temple, R.J.1
  • 65
    • 77950521977 scopus 로고
    • Office of Drug Research and Review to Director, Division of Neuropharmacological Drug Products, 27 July
    • Temple R. J. 1984b, FDA Memo, 'Nomifensine', from Director, Office of Drug Research and Review to Director, Division of Neuropharmacological Drug Products, 27 July.
    • (1984) FDA Memo, 'Nomifensine', from Director
    • Temple, R.J.1
  • 66
    • 77950548335 scopus 로고
    • Office of Drug Research and Review to Hoescht-Roussel, 1 August
    • Temple R. J. 1984c, FDA Approvable Letter from Director, Office of Drug Research and Review to Hoescht-Roussel, 1 August.
    • (1984) FDA Approvable Letter from Director
    • Temple, R.J.1
  • 68
    • 77950536815 scopus 로고
    • Oversight of the new drug review process
    • US Congress, Hearings before a Subcommittee of the Committee on Government Operations. 22 May, Washington: US GPO
    • US Congress 1986, 'Oversight of the New Drug Review Process', Hearings before a Subcommittee of the Committee on Government Operations. House of Representatives 99th Congress, 22 May, Washington: US GPO.
    • (1986) House of Representatives 99th Congress
  • 69
    • 77950536518 scopus 로고    scopus 로고
    • US Congress 1987, Fifteenth Report, Committee on Government Operations, 'FDA's Regulation of the New Drug Merital', 8 July, Washington: US GPO
    • US Congress 1987, Fifteenth Report, Committee on Government Operations, 'FDA's Regulation of the New Drug Merital', 8 July, Washington: US GPO.
  • 72
    • 0021018887 scopus 로고
    • Detection of drug-specific IgE and IgG antibodies using RJA: Clinical relevance as illustrated for nomifensine
    • Waelti M., Neftel K., Cohen M., de Weck A. I. and Perisie M. 1983, 'Detection of Drug-Specific IgE and IgG Antibodies using RJA: Clinical Relevance as Illustrated for Nomifensine', Schweizerische Medizinische Wochenschrift, 113, 1865-1867
    • (1983) Schweizerische Medizinische Wochenschrift , vol.113 , pp. 1865-1867
    • Waelti, M.1    Neftel, K.2    Cohen, M.3    De Weck, A.I.4    Perisie, M.5
  • 74
    • 0019729388 scopus 로고
    • Drug fever due to a new antidepressant, nomifensine
    • Wiehe P., Thybo S. and Magnussen P. 1981, 'Drug Fever Due to a New Antidepressant, Nomifensine', Ugeskrift For Laeger, 143, 1330-1331
    • (1981) Ugeskrift for Laeger , vol.143 , pp. 1330-1331
    • Wiehe, P.1    Thybo, S.2    Magnussen, P.3


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.