메뉴 건너뛰기




Volumn 21, Issue 20, 2003, Pages 3859-3866

Dissemination of information on potentially fatal adverse drug reactions for cancer drugs from 2000 to 2002: First results from the research on adverse drug events and reports project

Author keywords

[No Author keywords available]

Indexed keywords

ANTINEOPLASTIC AGENT;

EID: 0142023879     PISSN: 0732183X     EISSN: None     Source Type: Journal    
DOI: 10.1200/JCO.2003.04.537     Document Type: Article
Times cited : (66)

References (74)
  • 1
    • 34247201404 scopus 로고    scopus 로고
    • United States General Accounting Office: FDA Drug Review: Postapproval risks, 1976-1985. Washington, DC, US General Accounting Office, publication GAO/PEMD-90-15, April 26, 1990.
    • United States General Accounting Office: FDA Drug Review: Postapproval risks, 1976-1985. Washington, DC, US General Accounting Office, publication GAO/PEMD-90-15, April 26, 1990.
  • 2
    • 0037189985 scopus 로고    scopus 로고
    • Postmarketing surveillance and black box warnings
    • Hampson JP, Harvey JN: Postmarketing surveillance and black box warnings. JAMA 288:955-956, 2002
    • (2002) JAMA , vol.288 , pp. 955-956
    • Hampson, J.P.1    Harvey, J.N.2
  • 3
    • 0033518849 scopus 로고    scopus 로고
    • Postmarketing surveillance and adverse drug reactions: Current perspectives and future needs
    • Brewer T, Colditz GA: Postmarketing surveillance and adverse drug reactions: Current perspectives and future needs. JAMA 281:824-829, 1999
    • (1999) JAMA , vol.281 , pp. 824-829
    • Brewer, T.1    Colditz, G.A.2
  • 4
    • 0034619028 scopus 로고    scopus 로고
    • Adverse drug reactions: Definitions, diagnosis, and management
    • Edwards IR, Aronson JK: Adverse drug reactions: Definitions, diagnosis, and management. Lancet 356:1255-1259, 2000
    • (2000) Lancet , vol.356 , pp. 1255-1259
    • Edwards, I.R.1    Aronson, J.K.2
  • 5
    • 0025719244 scopus 로고
    • Computerized surveillance of adverse drug events in hospital patients
    • Classen DC, Pestotnik SL, Evans RS, et al: Computerized surveillance of adverse drug events in hospital patients. JAMA 266:2847-2851, 1991
    • (1991) JAMA , vol.266 , pp. 2847-2851
    • Classen, D.C.1    Pestotnik, S.L.2    Evans, R.S.3
  • 6
  • 7
    • 0036787040 scopus 로고    scopus 로고
    • Pneumonitis associated with nonsteroidal antiandrogens: Presumptive evidence of a class effect
    • Bennett CL, Raisch DW, Sartor O: Pneumonitis associated with nonsteroidal antiandrogens: Presumptive evidence of a class effect. Ann Intern Med 137:625, 2002
    • (2002) Ann Intern Med , vol.137 , pp. 625
    • Bennett, C.L.1    Raisch, D.W.2    Sartor, O.3
  • 8
    • 0037075272 scopus 로고    scopus 로고
    • Pure red-cell aplasia and antierythropoietin antibodies in patients treated with recombinant erythropoietin
    • Casadevall N, Nataf J, Viron B, et al: Pure red-cell aplasia and antierythropoietin antibodies in patients treated with recombinant erythropoietin. N Engl J Med 346:469-475, 2002
    • (2002) N Engl J Med , vol.346 , pp. 469-475
    • Casadevall, N.1    Nataf, J.2    Viron, B.3
  • 9
    • 0035878068 scopus 로고    scopus 로고
    • Mylotarg (gemtuzumab ozogamicin) therapy is associated with hepatic venoocclusive disease in patients who have not received stem cell transplantation
    • Giles FJ, Kantarjian HM, Kornblau SM, et al: Mylotarg (gemtuzumab ozogamicin) therapy is associated with hepatic venoocclusive disease in patients who have not received stem cell transplantation. Cancer 92:406-413, 2001
    • (2001) Cancer , vol.92 , pp. 406-413
    • Giles, F.J.1    Kantarjian, H.M.2    Kornblau, S.M.3
  • 10
    • 34247246115 scopus 로고    scopus 로고
    • Bicalutamide package insert change for interstitial pneumonitis, 2001
    • Bicalutamide package insert change for interstitial pneumonitis, 2001. http://www.fda.gov/medwatch/safety/2001/feb01.htm#casode
  • 11
    • 34247261407 scopus 로고    scopus 로고
    • Cyclophosphamide package insert change for Stevens-Johnson syndrome, 2001
    • Cyclophosphamide package insert change for Stevens-Johnson syndrome, 2001. http://www.fda.gov/medwatch/SAFETY/2001/jan01.htm#cytoxa
  • 12
    • 34247204090 scopus 로고    scopus 로고
    • Fludarabine package insert change for trilineage hypoplasia or aplasia, 2001
    • Fludarabine package insert change for trilineage hypoplasia or aplasia, 2001. http://www.fda.gov/medwatch/safety/2001/dec01.htm#fludar
  • 13
    • 34247280914 scopus 로고    scopus 로고
    • Gemcitabine package insert change for hemolytic uremic syndrome, 2000
    • Gemcitabine package insert change for hemolytic uremic syndrome, 2000. http://www.fda.gov/medwatch/safety/2000/jun00.htm#gemzar
  • 14
    • 34247246635 scopus 로고    scopus 로고
    • Interferon alfa-2a package insert change for severe neuropsychiatric disorders, 2002
    • Interferon alfa-2a package insert change for severe neuropsychiatric disorders, 2002. http://www.fda.gov/medwatch/SAFETY/2002/roferon_A_PI.pdf
  • 15
    • 34247231937 scopus 로고    scopus 로고
    • Interferon alfa-2b package insert change for severe neuropsychiatric disorders, 2001
    • Interferon alfa-2b package insert change for severe neuropsychiatric disorders, 2001. http://www.fda.gov/medwatch/safety/2001/oct01.htm#rebetr
  • 16
    • 34247250120 scopus 로고    scopus 로고
    • Pamidronate package insert change for severe renal toxicity, 2002. Available at
    • Pamidronate package insert change for severe renal toxicity, 2002. Available at: http://www.fda.gov/medwatch/SAFETY/2002/jul02.htm#aredia
  • 17
    • 34247224701 scopus 로고    scopus 로고
    • Rituximab package insert change for severe infusion reactions, 1998
    • Rituximab package insert change for severe infusion reactions, 1998. http://www.fda.gov/medwatch/safety/1998/safety98.htm#rituxa
  • 18
    • 34247206388 scopus 로고    scopus 로고
    • Tamoxifen package insert change for uterine sarcoma and endometrial adenocarcinoma, 2002
    • Tamoxifen package insert change for uterine sarcoma and endometrial adenocarcinoma, 2002. http://www.fda.gov/medwatch/SAFETY/2002/may02.htm#nolvad
  • 19
    • 34247191064 scopus 로고    scopus 로고
    • Trastuzumab package insert change for severe infusion reactions, 2000
    • Trastuzumab package insert change for severe infusion reactions, 2000. http://www.fda.gov/medwatch/safety/2000/herceppi.pdf
  • 20
    • 34247247588 scopus 로고    scopus 로고
    • Vinorelbine package insert change for interstitial pneumonitis, 2000
    • Vinorelbine package insert change for interstitial pneumonitis, 2000. http://www.fda.gov/medwatch/safety/2000/may00.htm#navelb
  • 21
    • 34247222984 scopus 로고    scopus 로고
    • Capecitabine package insert change for warfarin interaction, 2001
    • Capecitabine package insert change for warfarin interaction, 2001. http://www.fda.gov/medwatch/safety/2001/xeloda_changes.PDF
  • 22
    • 34247249225 scopus 로고    scopus 로고
    • Capecitabine package insert change for severe renal insufficiency, 2000
    • Capecitabine package insert change for severe renal insufficiency, 2000. http://www.fda.gov/cder/foi/label/2000/208961bl.pdf
  • 23
    • 34247240916 scopus 로고    scopus 로고
    • Gemtuzumab package insert change for veno-occlusive disease, 2001
    • Gemtuzumab package insert change for veno-occlusive disease, 2001. http://www.fda.gov/medwatch/SAFETY/2001/may01.htm#mylota
  • 24
    • 34247242018 scopus 로고    scopus 로고
    • Gemtuzumab package insert change for severe infusion reactions, 2001
    • Gemtuzumab package insert change for severe infusion reactions, 2001. http://www.fda.gov/medwatch/SAFETY/2001/feb01.htm#mylota
  • 25
    • 34247203003 scopus 로고    scopus 로고
    • Imatinib package insert change for tumor or upper gastrointestinal bleed, 2002
    • Imatinib package insert change for tumor or upper gastrointestinal bleed, 2002. http://www.fda.gov/medwatch/SAFETY/2002/feb02.htm#gleeve
  • 26
    • 34247244526 scopus 로고    scopus 로고
    • Irinotecan package insert change for drug-related fatalities, 2002
    • Irinotecan package insert change for drug-related fatalities, 2002. http://www.fda.gov/medwatch/SAFETY/2002/camptosar_label_highlighted.pdf
  • 27
    • 34247227389 scopus 로고    scopus 로고
    • Pamidronate initial package insert change for severe renal toxicity, 2001
    • Pamidronate initial package insert change for severe renal toxicity, 2001. http://www.fda.gov/medwatch/safety/2001/aug01.htm#aredia
  • 28
    • 0035283137 scopus 로고    scopus 로고
    • Torsades de pointes in 3 patients with leukemia treated with arsenic trioxide
    • Unnikrishnan D, Dutcher JP, Varshneya N, et al: Torsades de pointes in 3 patients with leukemia treated with arsenic trioxide. Blood 97:1514-1516, 2001
    • (2001) Blood , vol.97 , pp. 1514-1516
    • Unnikrishnan, D.1    Dutcher, J.P.2    Varshneya, N.3
  • 29
    • 0035902209 scopus 로고    scopus 로고
    • Serratia liquefaciens bloodstream infections from contamination of epoetin alfa at a hemodialysis center
    • Grohskopf LA, Roth VR, Feikin DR, et al: Serratia liquefaciens bloodstream infections from contamination of epoetin alfa at a hemodialysis center. N Engl J Med 344:1491-1497, 2001
    • (2001) N Engl J Med , vol.344 , pp. 1491-1497
    • Grohskopf, L.A.1    Roth, V.R.2    Feikin, D.R.3
  • 30
    • 0033134916 scopus 로고    scopus 로고
    • A review of hemolytic uremic syndrome in patients treated with gemcitabine therapy
    • Fung MC, Storniolo AM, Nguyen B, et al: A review of hemolytic uremic syndrome in patients treated with gemcitabine therapy. Cancer 85:2023-2032, 1999
    • (1999) Cancer , vol.85 , pp. 2023-2032
    • Fung, M.C.1    Storniolo, A.M.2    Nguyen, B.3
  • 31
    • 0035007762 scopus 로고    scopus 로고
    • Collapsing focal segmental glomerulosclerosis following treatment with high-dose pamidronate
    • Markowitz GS, Appel GB, Fine PL, et al: Collapsing focal segmental glomerulosclerosis following treatment with high-dose pamidronate. J Am Soc Nephrol 12:1164-1172, 2001
    • (2001) J Am Soc Nephrol , vol.12 , pp. 1164-1172
    • Markowitz, G.S.1    Appel, G.B.2    Fine, P.L.3
  • 32
    • 0033214207 scopus 로고    scopus 로고
    • Cytokine-release syndrome in patients with B-cell chronic lymphocytic leukemia and high lymphocyte counts after treatment with an anti-CD20 monoclonal antibody (Rituximab)
    • Winker U, Jensen M, Manzke O, et al: Cytokine-release syndrome in patients with B-cell chronic lymphocytic leukemia and high lymphocyte counts after treatment with an anti-CD20 monoclonal antibody (Rituximab). Blood 94:2217-2224, 1999
    • (1999) Blood , vol.94 , pp. 2217-2224
    • Winker, U.1    Jensen, M.2    Manzke, O.3
  • 33
    • 0034626064 scopus 로고    scopus 로고
    • Risk and prognosis of endometrial cancer after tamoxifen for breast cancer: Comprehensive Cancer ALERT Group-Assessment of liver and endometrial cancer risk following tamoxifen
    • Bergman L, Beelen ML, Gallee MP, et al: Risk and prognosis of endometrial cancer after tamoxifen for breast cancer: Comprehensive Cancer ALERT Group-Assessment of liver and endometrial cancer risk following tamoxifen. Lancet 356:881-887, 2000
    • (2000) Lancet , vol.356 , pp. 881-887
    • Bergman, L.1    Beelen, M.L.2    Gallee, M.P.3
  • 34
    • 0033506258 scopus 로고    scopus 로고
    • Infusion reactions associated with the therapeutic use of monoclonal antibodies in the treatment of malignancy
    • Dillman RO: Infusion reactions associated with the therapeutic use of monoclonal antibodies in the treatment of malignancy. Cancer Metastasis Rev 18:465-471, 1999
    • (1999) Cancer Metastasis Rev , vol.18 , pp. 465-471
    • Dillman, R.O.1
  • 35
    • 0030469484 scopus 로고    scopus 로고
    • Acute pulmonary toxicity associated with high-dose vinorelbine and mitomycin C
    • Raderer M, Kornek G, Hejna M, et al: Acute pulmonary toxicity associated with high-dose vinorelbine and mitomycin C. Ann Oncol 7:973-975, 1996
    • (1996) Ann Oncol , vol.7 , pp. 973-975
    • Raderer, M.1    Kornek, G.2    Hejna, M.3
  • 36
    • 0035397980 scopus 로고    scopus 로고
    • Efficacy and safety of gemtuzumab ozogamicin in patients with CD33-positive acute myeloid leukemia in first relapse
    • Sievers EL, Larson RA, Stadtmauer EA, et al: Efficacy and safety of gemtuzumab ozogamicin in patients with CD33-positive acute myeloid leukemia in first relapse. J Clin Oncol 19:3244-3254, 2001
    • (2001) J Clin Oncol , vol.19 , pp. 3244-3254
    • Sievers, E.L.1    Larson, R.A.2    Stadtmauer, E.A.3
  • 37
    • 0037103424 scopus 로고    scopus 로고
    • Efficacy and safety of imatinib mesylate in advanced gastrointestinal stromal tumors
    • Demetri GD, von Mehren M, Blanke CD, et al: Efficacy and safety of imatinib mesylate in advanced gastrointestinal stromal tumors. N Engl J Med 347:472-480, 2002
    • (2002) N Engl J Med , vol.347 , pp. 472-480
    • Demetri, G.D.1    von Mehren, M.2    Blanke, C.D.3
  • 38
    • 0035849938 scopus 로고    scopus 로고
    • Recommendation for caution with irinotecan, fluorouracil, and leucovorin for colorectal cancer
    • Sargent DJ, Niedzwiecki D, O'Connell MJ, et al: Recommendation for caution with irinotecan, fluorouracil, and leucovorin for colorectal cancer. N Engl J Med 345:144-145, 2001
    • (2001) N Engl J Med , vol.345 , pp. 144-145
    • Sargent, D.J.1    Niedzwiecki, D.2    O'Connell, M.J.3
  • 39
    • 0036853297 scopus 로고    scopus 로고
    • Thalidomide-associated deep vein thrombosis and pulmonary embolism
    • Bennett CL, Schumock GT, Desai AA, et al: Thalidomide-associated deep vein thrombosis and pulmonary embolism. Am J Med 113:603-606, 2002
    • (2002) Am J Med , vol.113 , pp. 603-606
    • Bennett, C.L.1    Schumock, G.T.2    Desai, A.A.3
  • 40
    • 0033982566 scopus 로고    scopus 로고
    • Deep vein thrombosis of the arm after intravenous immunoglobulin infusion: Case report and literature review of intravenous immunoglobulin-related thrombotic complications
    • Go RS, Call TG: Deep vein thrombosis of the arm after intravenous immunoglobulin infusion: Case report and literature review of intravenous immunoglobulin-related thrombotic complications. Mayo Clin Proc 75:83-85, 2000
    • (2000) Mayo Clin Proc , vol.75 , pp. 83-85
    • Go, R.S.1    Call, T.G.2
  • 52
    • 34247261907 scopus 로고    scopus 로고
    • United States General Accounting Office: FDA Drug Review-Postapproval risks, 1976-85. Washington, DC, US General Accounting Office, publication GAO/PEMD-90-15, April 26, 1990
    • United States General Accounting Office: FDA Drug Review-Postapproval risks, 1976-85. Washington, DC, US General Accounting Office, publication GAO/PEMD-90-15, April 26, 1990
  • 53
    • 0032542251 scopus 로고    scopus 로고
    • Making medicines safer: The need for an independent drug safety board
    • Wood AJ, Stein CM, Woosley R: Making medicines safer: The need for an independent drug safety board. N Engl J Med 339:1851-1854, 1998
    • (1998) N Engl J Med , vol.339 , pp. 1851-1854
    • Wood, A.J.1    Stein, C.M.2    Woosley, R.3
  • 54
    • 0032508249 scopus 로고    scopus 로고
    • Underreporting of suspected adverse drug reactions to newly marketed ("black triangle") drugs in general practice
    • Martin RM, Kapoor KV, Wilton LV, et al: Underreporting of suspected adverse drug reactions to newly marketed ("black triangle") drugs in general practice. BMJ 317:119-120, 1998
    • (1998) BMJ , vol.317 , pp. 119-120
    • Martin, R.M.1    Kapoor, K.V.2    Wilton, L.V.3
  • 55
    • 0031696868 scopus 로고    scopus 로고
    • Prescription event monitoring: Recent progress and future horizons
    • Mann RD: Prescription event monitoring: Recent progress and future horizons. Br J Clin Pharm 46:195-201, 1998
    • (1998) Br J Clin Pharm , vol.46 , pp. 195-201
    • Mann, R.D.1
  • 56
    • 0036723793 scopus 로고    scopus 로고
    • Adverse drug reactions: Current issues and strategies for prevention and management
    • Khong TK, Singer DRJ: Adverse drug reactions: Current issues and strategies for prevention and management. Expert Opin Pharmacother 3:1289-1300, 2002
    • (2002) Expert Opin Pharmacother , vol.3 , pp. 1289-1300
    • Khong, T.K.1    Singer, D.R.J.2
  • 57
    • 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 287:2215-2220, 2002
    • (2002) JAMA , vol.287 , pp. 2215-2220
    • Lasser, K.E.1    Allen, P.D.2    Woolhandler, S.J.3
  • 58
    • 0032751138 scopus 로고    scopus 로고
    • Warfarin-5-FU interaction: A consecutive cast series
    • Kolesar JM, Johnson CL, Freeberg BL, et al: Warfarin-5-FU interaction: A consecutive cast series. Pharmacotherapy 19:1445-1449, 1999
    • (1999) Pharmacotherapy , vol.19 , pp. 1445-1449
    • Kolesar, J.M.1    Johnson, C.L.2    Freeberg, B.L.3
  • 59
    • 0036530040 scopus 로고    scopus 로고
    • Development of pancytopenia with neutralizing antibodies after multicycle chemotherapy supported by megakaryocyte growth and development factor
    • Baser RL, O'Flaherty E, Green M, et al: Development of pancytopenia with neutralizing antibodies after multicycle chemotherapy supported by megakaryocyte growth and development factor. Blood 99:2599-2602, 2002
    • (2002) Blood , vol.99 , pp. 2599-2602
    • Baser, R.L.1    O'Flaherty, E.2    Green, M.3
  • 60
    • 0035760892 scopus 로고    scopus 로고
    • Thrombocytopenia caused by the development of antibodies to thrombopoietin
    • Li J, Yang C, Xia Y, et al: Thrombocytopenia caused by the development of antibodies to thrombopoietin. Blood 98:3241-3248, 2001
    • (2001) Blood , vol.98 , pp. 3241-3248
    • Li, J.1    Yang, C.2    Xia, Y.3
  • 61
    • 0036569927 scopus 로고    scopus 로고
    • Safety of newly approved drugs: Implications for prescribing
    • Temple RJ, Himmel MH: Safety of newly approved drugs: Implications for prescribing. JAMA 287:2273-2275, 2002
    • (2002) JAMA , vol.287 , pp. 2273-2275
    • Temple, R.J.1    Himmel, M.H.2
  • 62
    • 0032055447 scopus 로고    scopus 로고
    • Thrombotic thrombocytopenic purpura associated with ticlopidine: A review of 60 cases
    • Bennett CL, Weinberg PD, Rozenberg-Ben-Dror K, et al: Thrombotic thrombocytopenic purpura associated with ticlopidine: A review of 60 cases. Ann Intern Med 128:541-544, 1998
    • (1998) Ann Intern Med , vol.128 , pp. 541-544
    • Bennett, C.L.1    Weinberg, P.D.2    Rozenberg-Ben-Dror, K.3
  • 63
    • 34247227931 scopus 로고    scopus 로고
    • Aransep [darbepeotin alfa; package insert, Thousand Oaks, CA: Amgen Inc, 2001
    • Aransep [darbepeotin alfa; package insert], Thousand Oaks, CA: Amgen Inc, 2001, http://www.fda.gov/cber/label/darbamg071902LB2.pdf
  • 64
    • 34247192388 scopus 로고    scopus 로고
    • personal communication, August 25
    • Nancy Lee, Parm D (personal communication, August 25, 2003)
    • (2003)
    • Nancy Lee, P.D.1
  • 65
    • 0033549087 scopus 로고    scopus 로고
    • The safety of newly approved medicines: Do recent market removals mean there is a problem?
    • Friedman MA, Woodcock J, Lumpkin MM, et al: The safety of newly approved medicines: Do recent market removals mean there is a problem? JAMA 28:1728-1734, 1999
    • (1999) JAMA , vol.28 , pp. 1728-1734
    • Friedman, M.A.1    Woodcock, J.2    Lumpkin, M.M.3
  • 66
    • 34247257697 scopus 로고    scopus 로고
    • Center for Drug Evaluation and Research, Food and Drug Administration, Department of Health and Human Services
    • Fast track, priority, and accelerated approval: Oncology tools. Center for Drug Evaluation and Research, Food and Drug Administration, Department of Health and Human Services, http://www.accessdata.fda.gov/scripts/cder/onctools/ Accel.cfm
    • Fast track, priority, and accelerated approval: Oncology tools
  • 67
    • 34247279071 scopus 로고    scopus 로고
    • Accelerated approval of new drugs for serious or life-threatening illnesses. 21 Subpart H, Code of Federal Regulations, 314.510, 1992
    • Accelerated approval of new drugs for serious or life-threatening illnesses. 21 Subpart H, Code of Federal Regulations, 314.510, 1992
  • 68
    • 34247201923 scopus 로고    scopus 로고
    • Accelerated approval of new drugs for serious or life-threatening illnesses. 21 Subpart H, Code of Federal Regulations, 314.510, 1992
    • Accelerated approval of new drugs for serious or life-threatening illnesses. 21 Subpart H, Code of Federal Regulations, 314.510, 1992
  • 70
    • 34247247587 scopus 로고    scopus 로고
    • Accelerated Approvals in Oncology: A 10-Year Experience
    • March 12
    • Dagher R: Accelerated Approvals in Oncology: A 10-Year Experience. March 12, 2003. Presentation to the Oncologic Drugs Advisory Committee. http://www.fda.gov/ohrms/dockets/ac/03/slides/3936sl.htm
    • (2003) Presentation to the Oncologic Drugs Advisory Committee
    • Dagher, R.1
  • 72
    • 0034694911 scopus 로고    scopus 로고
    • Drug labeling revisions: Guaranteed to fail
    • Woolsey R: Drug labeling revisions: Guaranteed to fail. JAMA 284:3047-3049, 2000
    • (2000) JAMA , vol.284 , pp. 3047-3049
    • Woolsey, R.1
  • 73
    • 0037163460 scopus 로고    scopus 로고
    • Concurrent use of selected agents with moxifloxacin: An examination of labeling compliance within 1 year of marketing
    • Brinker A, Staffa J: Concurrent use of selected agents with moxifloxacin: An examination of labeling compliance within 1 year of marketing. Arch Intern Med 162:2011-2012, 2002
    • (2002) Arch Intern Med , vol.162 , pp. 2011-2012
    • Brinker, A.1    Staffa, J.2


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.