메뉴 건너뛰기




Volumn 46, Issue 6, 2016, Pages 477-489

Worldwide withdrawal of medicinal products because of adverse drug reactions: a systematic review and analysis

Author keywords

Adverse reaction; interval; side effect; systematic review; worldwide recall

Indexed keywords

APROTININ; BENOXAPROFEN; CATECHIN; CENTOXIN; CERIVASTATIN; CHLORMEZANONE; CHLORPROGUANIL PLUS DAPSONE; CYCLOOXYGENASE 1 INHIBITOR; CYCLOOXYGENASE 2 INHIBITOR; DILEVALOL; DOMPERIDONE; FENCLOFENAC; FENFLURAMINE; GLAFENINE; GREPAFLOXACIN; HERBACEOUS AGENT; INDOPROFEN; ISOXICAM; LAROPIPRANT PLUS NICOTINIC ACID; LOPERAMIDE; MUZOLIMINE; NOMIFENSINE; OXYPHENBUTAZONE; PEMOLINE; PIRPROFEN; PRENYLAMINE; RICINOMACROGOL; ROFECOXIB; TRYPTOPHAN; UNINDEXED DRUG;

EID: 84961233831     PISSN: 10408444     EISSN: 15476898     Source Type: Journal    
DOI: 10.3109/10408444.2016.1149452     Document Type: Review
Times cited : (88)

References (35)
  • 1
    • 84941636370 scopus 로고    scopus 로고
    • The flaws and human harms of animal experimentation
    • A.Akhtar,, 2015. The flaws and human harms of animal experimentation. Cambridge quarterly of healthcare ethics, 24, 407–419.
    • (2015) Cambridge quarterly of healthcare ethics , vol.24 , pp. 407-419
    • Akhtar, A.1
  • 2
    • 84977510876 scopus 로고
    • Fenclofenac withdrawn
    • Anonymous, 1984. Fenclofenac withdrawn. The lancet, 2, 56.
    • (1984) The lancet , vol.2 , pp. 56
  • 4
    • 77957775831 scopus 로고    scopus 로고
    • Preventability of drug-related harms - part II: proposed criteria, based on frameworks that classify adverse drug reactions
    • J.K.Aronson, and R.E.Ferner,, 2010. Preventability of drug-related harms - part II: proposed criteria, based on frameworks that classify adverse drug reactions. Drug safety, 33, 995–1002.
    • (2010) Drug safety , vol.33 , pp. 995-1002
    • Aronson, J.K.1    Ferner, R.E.2
  • 5
    • 1842734345 scopus 로고    scopus 로고
    • Implementing the precautionary principle: incorporating science, technology, fairness, and accountability in environmental, health, and safety decisions
    • N.A.Ashford,, 2004. Implementing the precautionary principle: incorporating science, technology, fairness, and accountability in environmental, health, and safety decisions. International journal of occupational medicine and environmental health, 17, 59–67.
    • (2004) International journal of occupational medicine and environmental health , vol.17 , pp. 59-67
    • Ashford, N.A.1
  • 6
    • 0031068049 scopus 로고    scopus 로고
    • Animal research is wasteful and misleading
    • N.D.Barnard, and S.R.Kaufman,, 1997. Animal research is wasteful and misleading. Scientific American, 276, 80–82.
    • (1997) Scientific American , vol.276 , pp. 80-82
    • Barnard, N.D.1    Kaufman, S.R.2
  • 7
    • 62749199801 scopus 로고    scopus 로고
    • Why animal studies are often poor predictors of human reactions to exposure
    • M.B.Bracken,, 2009. Why animal studies are often poor predictors of human reactions to exposure. Journal of the royal society of medicine, 102, 120–122.
    • (2009) Journal of the royal society of medicine , vol.102 , pp. 120-122
    • Bracken, M.B.1
  • 8
    • 84977559045 scopus 로고    scopus 로고
    • European Commission, 2009. A guideline on summary of product characteristics (SmPC). Available from: http://ec.europa.eu/health/files/eudralex/vol-2/c/smpc_guideline_rev2_en.pdf [Accessed 15 September 2015].
    • (2009)
  • 9
    • 84977480446 scopus 로고    scopus 로고
    • European Medicines Agency, 2012. Standard operating procedure. Available from: http://www.ema.europa.eu/docs/en_GB/document_library/Standard_Operating_Procedure_-_SOP/2009/09/WC500003189.pdf [Accessed 15 September 2015].
    • (2012)
  • 10
    • 0017806118 scopus 로고
    • Mammary nodules in beagle dogs administered investigational oral contraceptive steroids
    • R.C.Giles,, et al., 1978. Mammary nodules in beagle dogs administered investigational oral contraceptive steroids. Journal of the national cancer institute, 60, 1351–1364.
    • (1978) Journal of the national cancer institute , vol.60 , pp. 1351-1364
    • Giles, R.C.1
  • 11
    • 11344266964 scopus 로고    scopus 로고
    • Alternatives to animal experimentation in basic research
    • F.P.Gruber, and T.Hartung,, 2004. Alternatives to animal experimentation in basic research. Alternatives to animal experiments, 21, 3–31.
    • (2004) Alternatives to animal experiments , vol.21 , pp. 3-31
    • Gruber, F.P.1    Hartung, T.2
  • 12
    • 77955391449 scopus 로고    scopus 로고
    • A review of quantitative risk-benefit methodologies for assessing drug safety and efficacy-report of the ISPOR risk-benefit management working group
    • J.J.Guo,, et al., 2010. A review of quantitative risk-benefit methodologies for assessing drug safety and efficacy-report of the ISPOR risk-benefit management working group. Value health, 13, 657–666.
    • (2010) Value health , vol.13 , pp. 657-666
    • Guo, J.J.1
  • 13
    • 84902597896 scopus 로고    scopus 로고
    • The need for randomization in animal trials: an overview of systematic reviews
    • J.A.Hirst,, et al., 2014. The need for randomization in animal trials: an overview of systematic reviews. PLoS one, 9, e98856.
    • (2014) PLoS one , vol.9 , pp. e98856
    • Hirst, J.A.1
  • 14
    • 9944262983 scopus 로고    scopus 로고
    • Risk of cardiovascular events and rofecoxib: cumulative meta-analysis
    • P.Jüni,, et al., 2004. Risk of cardiovascular events and rofecoxib: cumulative meta-analysis. The lancet, 364, 2021–2029.
    • (2004) The lancet , vol.364 , pp. 2021-2029
    • Jüni, P.1
  • 15
    • 84876172734 scopus 로고    scopus 로고
    • Evidence summaries: the evolution of a rapid review approach
    • S.Khangura,, et al., 2012. Evidence summaries: the evolution of a rapid review approach. Systematic reviews, 1, 10.
    • (2012) Systematic reviews , vol.1 , pp. 10
    • Khangura, S.1
  • 16
    • 79960983975 scopus 로고    scopus 로고
    • Thalidomide: the tragedy of birth defects and the effective treatment of disease
    • J.H.Kim, and A.R.Scialli,, 2011. Thalidomide: the tragedy of birth defects and the effective treatment of disease. Toxicological sciences, 122, 1–6.
    • (2011) Toxicological sciences , vol.122 , pp. 1-6
    • Kim, J.H.1    Scialli, A.R.2
  • 17
    • 46749087956 scopus 로고    scopus 로고
    • Systematic reviews of animal experiments demonstrate poor contributions toward human healthcare
    • A.Knight,, 2008. Systematic reviews of animal experiments demonstrate poor contributions toward human healthcare. Reviews on recent clinical trials, 3, 89–96.
    • (2008) Reviews on recent clinical trials , vol.3 , pp. 89-96
    • Knight, A.1
  • 18
    • 0018893436 scopus 로고
    • Malignant mammary tumors in beagle dogs dosed with investigational oral contraceptive steroids
    • R.P.Kwapien,, et al., 1980. Malignant mammary tumors in beagle dogs dosed with investigational oral contraceptive steroids. Journal of the national cancer institute, 65, 137–144.
    • (1980) Journal of the national cancer institute , vol.65 , pp. 137-144
    • Kwapien, R.P.1
  • 19
    • 32844475507 scopus 로고    scopus 로고
    • Case reports of suspected adverse drug reactions-systematic literature survey of follow-up
    • Y.K.Loke,, et al., 2006. Case reports of suspected adverse drug reactions-systematic literature survey of follow-up. British medical journal, 332, 335–339.
    • (2006) British medical journal , vol.332 , pp. 335-339
    • Loke, Y.K.1
  • 20
    • 84919950805 scopus 로고    scopus 로고
    • Dissemination bias in systematic reviews of animal research: a systematic review
    • K.F.Mueller,, et al., 2014. Dissemination bias in systematic reviews of animal research: a systematic review. PLoS one, 9, e116016
    • (2014) PLoS one , vol.9 , pp. e116016
    • Mueller, K.F.1
  • 21
    • 84924082630 scopus 로고    scopus 로고
    • Delays in the post-marketing withdrawal of drugs to which deaths have been attributed: a systematic investigation and analysis
    • I.J.Onakpoya,, et al., 2015. Delays in the post-marketing withdrawal of drugs to which deaths have been attributed: a systematic investigation and analysis. BMC medicine, 13, 26.
    • (2015) BMC medicine , vol.13 , pp. 26
    • Onakpoya, I.J.1
  • 22
    • 84959338530 scopus 로고    scopus 로고
    • Post-marketing withdrawal of 462 medicinal products because of adverse drug reactions: a systematic review of the world literature
    • I.J.Onakpoya,, et al., 2016. Post-marketing withdrawal of 462 medicinal products because of adverse drug reactions: a systematic review of the world literature. BMC medicine, 14(1), 10. doi: 10.1186/s12916-016-0553-2.
    • (2016) BMC medicine , vol.14 , Issue.1 , pp. 10
    • Onakpoya, I.J.1
  • 23
    • 80053277530 scopus 로고    scopus 로고
    • Oxford Centre for Evidence-Based Medicine
    • OCEBM Levels of Evidence Working Group, 2011. The Oxford 2011 levels of evidence. Oxford Centre for Evidence-Based Medicine. Available from: http://www.cebm.net/index.aspx?o=5653 [Accessed 17 July 2015].
    • (2011) The Oxford 2011 levels of evidence
  • 24
    • 11844269320 scopus 로고    scopus 로고
    • Precautionary principles: a jurisdiction-free framework for decision-making under risk
    • P.F.Ricci,, et al., 2004. Precautionary principles: a jurisdiction-free framework for decision-making under risk. Human & experimental toxicology, 23, 579–600.
    • (2004) Human & experimental toxicology , vol.23 , pp. 579-600
    • Ricci, P.F.1
  • 26
    • 24644445725 scopus 로고    scopus 로고
    • The ethical basis of the precautionary principle in health care decision making
    • R.H.ter Meulen,, 2005. The ethical basis of the precautionary principle in health care decision making. Toxicology and applied pharmacology, 207, 663–667.
    • (2005) Toxicology and applied pharmacology , vol.207 , pp. 663-667
    • ter Meulen, R.H.1
  • 27
    • 84924917599 scopus 로고    scopus 로고
    • Whitehouse Station, NJ: Merck Sharp & Dohme Corp, a subsidiary of Merck & Co, Inc
    • The Merck Index, 2013. Encyclopedia of chemicals, drugs, and biologicals. Whitehouse Station, NJ: Merck Sharp & Dohme Corp, a subsidiary of Merck & Co, Inc.
    • (2013) Encyclopedia of chemicals, drugs, and biologicals
  • 28
    • 0034414637 scopus 로고    scopus 로고
    • Conclusions. The precautionary principle: its advantages and risks
    • M.Tubiana,, 2000. Conclusions. The precautionary principle: its advantages and risks. Bulletin de l'Académie nationale de médecine, 184, 969–993.
    • (2000) Bulletin de l'Académie nationale de médecine , vol.184 , pp. 969-993
    • Tubiana, M.1
  • 29
    • 84977488584 scopus 로고    scopus 로고
    • United States Food and Drug Administration (FDA), 2013. Regulatory procedures manual – October 2013. Chapter 7. Recall procedures. Available from: http://www.fda.gov/downloads/ICECI/ComplianceManuals/RegulatoryProceduresManual/UCM074312.pdf [Accessed 15 September 2015].
    • (2013)
  • 30
    • 84977578813 scopus 로고    scopus 로고
    • United States Food and Drug Administration (FDA), 2014a. Inside clinical trials: testing medical products in people. Available from: http://www.fda.gov/Drugs/ResourcesForYou/Consumers/ucm143531.htm [Accessed 15 September 2015].
    • (2014)
  • 31
    • 84977501166 scopus 로고    scopus 로고
    • United States Food and Drug Administration (FDA), 2014b. Accelerated approval program. Available from: http://www.fda.gov/ForPatients/Approvals/Fast/ucm405447.htm [Accessed 17 November 2015].
    • (2014)
  • 32
    • 84921823783 scopus 로고    scopus 로고
    • Systematic reviews of animal studies; missing link in translational research?
    • J.van Luijk,, et al., 2014. Systematic reviews of animal studies; missing link in translational research? PLoS one, 9, e89981.
    • (2014) PLoS one , vol.9 , pp. e89981
    • van Luijk, J.1
  • 34
    • 84977587362 scopus 로고    scopus 로고
    • Wingspread Conference on the Precautionary Principle, 1998. Available from: http://www.sehn.org/wing.html [Accessed 11 November 2015].
    • (1998)
  • 35
    • 84977569604 scopus 로고    scopus 로고
    • World Health Organization Collaborating Centre for Drug Statistics Methodology (WHO), 2008. Complete ATC/DDD Index. Available from: http://www.whocc.no/atcddd [Accessed 21 April 2013].
    • (2008)


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.