메뉴 건너뛰기




Volumn 50, Issue 4, 2007, Pages 353-357

Short patent lives jeopardize drug and patient safety

Author keywords

Adverse drug reactions; Drug safety; Patent life; Proarrhythmia

Indexed keywords

FEXOFENADINE; SPARFLOXACIN; TERFENADINE;

EID: 37349047786     PISSN: 01602446     EISSN: None     Source Type: Journal    
DOI: 10.1097/FJC.0b013e3181514032     Document Type: Note
Times cited : (3)

References (33)
  • 1
    • 0037374498 scopus 로고    scopus 로고
    • The price of innovation: New estimates of drug development costs
    • DiMasi JA, Hansen RW, Grabowsky HG. The price of innovation: new estimates of drug development costs. J Health Econ. 2003;22:151-185.
    • (2003) J Health Econ , vol.22 , pp. 151-185
    • DiMasi, J.A.1    Hansen, R.W.2    Grabowsky, H.G.3
  • 2
    • 33645675960 scopus 로고    scopus 로고
    • Estimating the cost of new drug development: Is it really 802 million dollars?
    • Adams CP, Brantner VV. Estimating the cost of new drug development: is it really 802 million dollars? Health Aff (Millwood). 2006;25:420-428.
    • (2006) Health Aff (Millwood) , vol.25 , pp. 420-428
    • Adams, C.P.1    Brantner, V.V.2
  • 3
    • 37349095784 scopus 로고    scopus 로고
    • United States Patent and Trade Office. Manual of Patent Examining Procedure (MPEP, Edition 8 E8, August 2001, Last Revision August 2006. Chapter 2700 Patent Terms and Extensions. 2701. Patent Term [R-2, Available at: www.uspto.gov/main/sitesearch.htm
    • United States Patent and Trade Office. Manual of Patent Examining Procedure (MPEP). Edition 8 (E8), August 2001, Last Revision August 2006. Chapter 2700 Patent Terms and Extensions. 2701. Patent Term [R-2]. Available at: www.uspto.gov/main/sitesearch.htm.
  • 4
    • 37349120561 scopus 로고    scopus 로고
    • ICH Harmonized Tripartite Guideline, The nonclinical evaluation of the potential for delayed ventricular repolarization (QT interval prolongation) by human pharmaceuticals. S7B. 2005. Available at: http://www.ich.org/LOB/media/ MEDIA2192.pdf.
    • ICH Harmonized Tripartite Guideline, The nonclinical evaluation of the potential for delayed ventricular repolarization (QT interval prolongation) by human pharmaceuticals. S7B. 2005. Available at: http://www.ich.org/LOB/media/ MEDIA2192.pdf.
  • 6
    • 37349109488 scopus 로고    scopus 로고
    • Draft Consensus guideline. The clinical evaluation of QT/QTc interval prolongation and proarrhythmic potential for non-antiarrhythmic drugs (E14) (2004). Available at: http://www.ich.org.
    • Draft Consensus guideline. The clinical evaluation of QT/QTc interval prolongation and proarrhythmic potential for non-antiarrhythmic drugs (E14) (2004). Available at: http://www.ich.org.
  • 7
    • 0344492207 scopus 로고    scopus 로고
    • Relationships between preclinical cardiac electrophysiology, clinical QT interval prolongation and torsade de pointes for a broad range of drugs: Evidence for a provisional safety marging in drug development
    • Redfern WS, Carlsson L, Davis AS, et al. Relationships between preclinical cardiac electrophysiology, clinical QT interval prolongation and torsade de pointes for a broad range of drugs: evidence for a provisional safety marging in drug development. Cardiovasc Res. 2003;58:32-45.
    • (2003) Cardiovasc Res , vol.58 , pp. 32-45
    • Redfern, W.S.1    Carlsson, L.2    Davis, A.S.3
  • 8
    • 0036570099 scopus 로고    scopus 로고
    • Timing of new black box warnings and withdrawals for prescription medications
    • Lasser KE, Allen PD, Woolhandler SJ, et al. Timing of new black box warnings and withdrawals for prescription medications. JAMA. 2002;287:2215-2220.
    • (2002) JAMA , vol.287 , pp. 2215-2220
    • Lasser, K.E.1    Allen, P.D.2    Woolhandler, S.J.3
  • 9
    • 33645504676 scopus 로고    scopus 로고
    • Learning from the TGN1412 trial
    • Goodyear M. Learning from the TGN1412 trial. BMJ. 2006;332:677-678.
    • (2006) BMJ , vol.332 , pp. 677-678
    • Goodyear, M.1
  • 11
    • 33645908148 scopus 로고    scopus 로고
    • COX-2 inhibitors and the heart: Are all coxbs the same?
    • Sooriakumaran P. COX-2 inhibitors and the heart: are all coxbs the same? Postgrad Med J. 2006;82:242-245.
    • (2006) Postgrad Med J , vol.82 , pp. 242-245
    • Sooriakumaran, P.1
  • 13
    • 33646744337 scopus 로고    scopus 로고
    • Under-reporting of adverse drug reactions: A systematic review
    • Hazell L, Shakir SA. Under-reporting of adverse drug reactions: a systematic review. Drug Saf. 2006;29:385-396.
    • (2006) Drug Saf , vol.29 , pp. 385-396
    • Hazell, L.1    Shakir, S.A.2
  • 14
    • 37349064285 scopus 로고    scopus 로고
    • Drug safety discontinuations in the United Kingdom, the United States, and Spain from 1974 through 1993: A regulatory perspective
    • Bakke OM, Manocchia M, de Abajo F, et al. Drug safety discontinuations in the United Kingdom, the United States, and Spain from 1974 through 1993: a regulatory perspective. Br J Clin Pharmacol. 1999;47:307-313.
    • (1999) Br J Clin Pharmacol , vol.47 , pp. 307-313
    • Bakke, O.M.1    Manocchia, M.2    de Abajo, F.3
  • 15
    • 33749027737 scopus 로고    scopus 로고
    • Can pharmacogenetics help rescue drugs withdrawn from the market?
    • Sha RS. Can pharmacogenetics help rescue drugs withdrawn from the market? Pharmacogenomics. 2006;7:889-908.
    • (2006) Pharmacogenomics , vol.7 , pp. 889-908
    • Sha, R.S.1
  • 16
    • 0032522873 scopus 로고    scopus 로고
    • Incidence of adverse drug reactions in hospitalized patients: A meta-analysis of prospective studies
    • Lazarou J, Poeranzz B, Corey PN. Incidence of adverse drug reactions in hospitalized patients: a meta-analysis of prospective studies. JAMA. 1998;279:1200-1205.
    • (1998) JAMA , vol.279 , pp. 1200-1205
    • Lazarou, J.1    Poeranzz, B.2    Corey, P.N.3
  • 17
    • 0030011760 scopus 로고    scopus 로고
    • Cardiac actions of antihistamines
    • Woosley R. Cardiac actions of antihistamines. Annu Rev Pharmacol Toxicol. 1996;36:233-252.
    • (1996) Annu Rev Pharmacol Toxicol , vol.36 , pp. 233-252
    • Woosley, R.1
  • 18
    • 0034694911 scopus 로고    scopus 로고
    • Drug label revisions - guaranteed to fail?
    • Woosley RL. Drug label revisions - guaranteed to fail? JAMA. 2000;284:3047-3049.
    • (2000) JAMA , vol.284 , pp. 3047-3049
    • Woosley, R.L.1
  • 19
    • 0037317605 scopus 로고    scopus 로고
    • Prescription of QT-prolonging drugs in a cohort of about 5 million outpatients
    • Curtis LH, Ostbye T, Senderky V, et al. Prescription of QT-prolonging drugs in a cohort of about 5 million outpatients. Am J Med. 2003;114:135-141.
    • (2003) Am J Med , vol.114 , pp. 135-141
    • Curtis, L.H.1    Ostbye, T.2    Senderky, V.3
  • 20
    • 3843111167 scopus 로고    scopus 로고
    • Inappropriate prescribing for elderly Americans in a large outpatient population
    • Curtis LH, Ostbye T, Senderky V, et al. Inappropriate prescribing for elderly Americans in a large outpatient population. Arch Intern Med. 2004;164:1621-1625.
    • (2004) Arch Intern Med , vol.164 , pp. 1621-1625
    • Curtis, L.H.1    Ostbye, T.2    Senderky, V.3
  • 21
    • 12144288682 scopus 로고    scopus 로고
    • Absolute contraindications in relationship to potential drug interactions in outpatient prescriptions: Analysis of the first five million prescriptions in 1999
    • Guédon-Moreau L, Ducrocq D, Duc MF, et al. Absolute contraindications in relationship to potential drug interactions in outpatient prescriptions: analysis of the first five million prescriptions in 1999. Eur J Clin Pharmacol. 2004;59:899-904.
    • (2004) Eur J Clin Pharmacol , vol.59 , pp. 899-904
    • Guédon-Moreau, L.1    Ducrocq, D.2    Duc, M.F.3
  • 22
    • 0033061972 scopus 로고    scopus 로고
    • Risk of ventricular arrhythmias associated with nonsedating antihistamine drugs
    • De Abajo FJ, Rodriguez LAG. Risk of ventricular arrhythmias associated with nonsedating antihistamine drugs. Br J Clin Pharmacol. 1999;47:307-313.
    • (1999) Br J Clin Pharmacol , vol.47 , pp. 307-313
    • De Abajo, F.J.1    Rodriguez, L.A.G.2
  • 23
    • 0030891384 scopus 로고    scopus 로고
    • Risks of non-sedating antihistamines
    • Lindquist M, Edwards IR. Risks of non-sedating antihistamines. Lancet. 1997;349:1322.
    • (1997) Lancet , vol.349 , pp. 1322
    • Lindquist, M.1    Edwards, I.R.2
  • 24
    • 34247463760 scopus 로고    scopus 로고
    • Paying for drug approvals - who's using whom?
    • Avorn J. Paying for drug approvals - who's using whom? N Engl J Med. 2007;356:1697-1700.
    • (2007) N Engl J Med , vol.356 , pp. 1697-1700
    • Avorn, J.1
  • 25
    • 34247492509 scopus 로고    scopus 로고
    • PDUFA reauthorization - drug safety's golden moment of opportunity?
    • Hennessy S, Strom BL. PDUFA reauthorization - drug safety's golden moment of opportunity? N Engl J Med. 2007;356:1703-1704.
    • (2007) N Engl J Med , vol.356 , pp. 1703-1704
    • Hennessy, S.1    Strom, B.L.2
  • 26
    • 34247477642 scopus 로고    scopus 로고
    • Drug safety reform at the FDA-pendulum swing or systematic improvement?
    • McClellan M. Drug safety reform at the FDA-pendulum swing or systematic improvement? N Engl J Med. 2007;356:1700-1702.
    • (2007) N Engl J Med , vol.356 , pp. 1700-1702
    • McClellan, M.1
  • 27
    • 27244448824 scopus 로고    scopus 로고
    • The patent-based pharmaceutical development process: Rationale, problems, and potential reform
    • Barton JH, Emanuel EJ. The patent-based pharmaceutical development process: rationale, problems, and potential reform. JAMA. 2005;294:2075-2082.
    • (2005) JAMA , vol.294 , pp. 2075-2082
    • Barton, J.H.1    Emanuel, E.J.2
  • 28
    • 33845435347 scopus 로고    scopus 로고
    • Drug-induced long QT and torsade de pointes: Recent advances
    • Kannankeril PJ, Roden DM. Drug-induced long QT and torsade de pointes: recent advances. Curr Opin Cardiol. 2007;1:39-43.
    • (2007) Curr Opin Cardiol , vol.1 , pp. 39-43
    • Kannankeril, P.J.1    Roden, D.M.2
  • 29
    • 0035901578 scopus 로고    scopus 로고
    • Instability and triangulation of the action potential predict serious proarrhythmia, but action potential duration prolongation is antiarrhythmic
    • Hondeghem LM, Carlsson L, Duker G. Instability and triangulation of the action potential predict serious proarrhythmia, but action potential duration prolongation is antiarrhythmic. Circulation. 2001;103:2004-2013.
    • (2001) Circulation , vol.103 , pp. 2004-2013
    • Hondeghem, L.M.1    Carlsson, L.2    Duker, G.3
  • 30
    • 33644786245 scopus 로고    scopus 로고
    • Thorough QT/QTc not so thorough: Removes torsadogenic predictors from the T-wave, incriminates safe drugs, and misses profibrillatory drugs
    • Hondeghem LM. Thorough QT/QTc not so thorough: removes torsadogenic predictors from the T-wave, incriminates safe drugs, and misses profibrillatory drugs. J Cardiovasc Electrophysiol. 2006;17:337-340.
    • (2006) J Cardiovasc Electrophysiol , vol.17 , pp. 337-340
    • Hondeghem, L.M.1
  • 31
    • 21344463329 scopus 로고    scopus 로고
    • Refining detection of drug-induced proarrhythmia: QT interval and TRIaD
    • Shah RR, Hondeghem LM. Refining detection of drug-induced proarrhythmia: QT interval and TRIaD. Heart Rhythm. 2005;2:758-772.
    • (2005) Heart Rhythm , vol.2 , pp. 758-772
    • Shah, R.R.1    Hondeghem, L.M.2
  • 33
    • 37349020815 scopus 로고    scopus 로고
    • Available at:, Accessed June 1
    • MHRA. Press Release: Medicines for Children. Available at: http:// 83.98.30.20/home/idcplg?IdcService=SS_GET_PAGE&useSecondary=true&ssDoc. Accessed June 1, 2006.
    • (2006) Release: Medicines for Children
    • Press, M.H.R.A.1


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.