메뉴 건너뛰기




Volumn 21, Issue 10, 2012, Pages 1134-1136

Post-market drug safety evidence sources: An analysis of FDA drug safety communications

Author keywords

[No Author keywords available]

Indexed keywords

DECISION MAKING; DRUG SAFETY; DRUG SURVEILLANCE PROGRAM; FOOD AND DRUG ADMINISTRATION; HEALTH CARE PERSONNEL; LETTER; POSTMARKETING SURVEILLANCE; PRIORITY JOURNAL; PUBLIC HEALTH;

EID: 84867116380     PISSN: 10538569     EISSN: 10991557     Source Type: Journal    
DOI: 10.1002/pds.3317     Document Type: Letter
Times cited : (32)

References (17)
  • 1
    • 79551614337 scopus 로고    scopus 로고
    • Role of postmarketing surveillance in contemporary medicine
    • Woodcock J, Behrman RE, Dal Pan GJ. Role of postmarketing surveillance in contemporary medicine. Annu Rev Med 2011; 62: 1-10.
    • (2011) Annu Rev Med , vol.62 , pp. 1-10
    • Woodcock, J.1    Behrman, R.E.2    Dal Pan, G.J.3
  • 2
    • 31344467254 scopus 로고    scopus 로고
    • The risk associated with aprotinin in cardiac surgery
    • Mangano DT, Tudor IC, Dietzel C. The risk associated with aprotinin in cardiac surgery. N Engl J Med 2006; 354(4): 353-365.
    • (2006) N Engl J Med , vol.354 , Issue.4 , pp. 353-365
    • Mangano, D.T.1    Tudor, I.C.2    Dietzel, C.3
  • 3
    • 39549099909 scopus 로고    scopus 로고
    • The effect of aprotinin on outcome after coronary-artery bypass grafting
    • Shaw AD, Stafford-Smith M, White WD, et al. The effect of aprotinin on outcome after coronary-artery bypass grafting. N Engl J Med 2008; 358(8): 784-793.
    • (2008) N Engl J Med , vol.358 , Issue.8 , pp. 784-793
    • Shaw, A.D.1    Stafford-Smith, M.2    White, W.D.3
  • 4
    • 39549100109 scopus 로고    scopus 로고
    • Aprotinin during coronary-artery bypass grafting and risk of death
    • Schneeweiss S, Seeger JD, Landon J, Walker AM. Aprotinin during coronary-artery bypass grafting and risk of death. N Engl J Med 2008; 358(8): 771-783.
    • (2008) N Engl J Med , vol.358 , Issue.8 , pp. 771-783
    • Schneeweiss, S.1    Seeger, J.D.2    Landon, J.3    Walker, A.M.4
  • 5
    • 0142186283 scopus 로고    scopus 로고
    • Erythropoietin to treat head and neck cancer patients with anaemia undergoing radiotherapy: randomised, double-blind, placebo-controlled trial
    • Henke M, Laszig R, Rube C, et al. Erythropoietin to treat head and neck cancer patients with anaemia undergoing radiotherapy: randomised, double-blind, placebo-controlled trial. Lancet 2003; 362(9392): 1255-1260.
    • (2003) Lancet , vol.362 , Issue.9392 , pp. 1255-1260
    • Henke, M.1    Laszig, R.2    Rube, C.3
  • 6
    • 24944454286 scopus 로고    scopus 로고
    • Maintaining normal hemoglobin levels with epoetin alfa in mainly nonanemic patients with metastatic breast cancer receiving first-line chemotherapy: a survival study
    • Leyland-Jones B, Semiglazov V, Pawlicki M, et al. Maintaining normal hemoglobin levels with epoetin alfa in mainly nonanemic patients with metastatic breast cancer receiving first-line chemotherapy: a survival study. J Clin Oncol 2005; 23(25): 5960-5972.
    • (2005) J Clin Oncol , vol.23 , Issue.25 , pp. 5960-5972
    • Leyland-Jones, B.1    Semiglazov, V.2    Pawlicki, M.3
  • 7
    • 84875004391 scopus 로고    scopus 로고
    • FDA. FDA Drug Safety Communication: Erythropoiesis-Stimulating Agents (ESAs): Procrit, Epogen and Aranesp. FDA,
    • FDA. FDA Drug Safety Communication: Erythropoiesis-Stimulating Agents (ESAs): Procrit, Epogen and Aranesp. FDA, 2010. http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm200297.htm
    • (2010)
  • 8
    • 81455159320 scopus 로고    scopus 로고
    • ADHD drugs and serious cardiovascular events in children and young adults
    • Cooper WO, Habel LA, Sox CM, et al. ADHD drugs and serious cardiovascular events in children and young adults. N Engl J Med 2011; 365(20): 1896-1904.
    • (2011) N Engl J Med , vol.365 , Issue.20 , pp. 1896-1904
    • Cooper, W.O.1    Habel, L.A.2    Sox, C.M.3
  • 9
    • 84867136660 scopus 로고    scopus 로고
    • FDA Drug Safety Communication: Safety Review Update of Medications used to treat Attention-Deficit/Hyperactivity Disorder (ADHD) in children and young adults. FDA, 11-1
    • FDA Drug Safety Communication: Safety Review Update of Medications used to treat Attention-Deficit/Hyperactivity Disorder (ADHD) in children and young adults. FDA, 11-1-2011.
    • (2011)
  • 10
    • 84867123316 scopus 로고    scopus 로고
    • FDA Directs ADHD Drug Manufacturers to Notify Patients about Cardiovascular Adverse Events and Psychiatric Adverse Events. FDA, 2-21
    • FDA Directs ADHD Drug Manufacturers to Notify Patients about Cardiovascular Adverse Events and Psychiatric Adverse Events. FDA, 2-21-2007.
    • (2007)
  • 11
    • 77957952617 scopus 로고    scopus 로고
    • Regulatory action on rosiglitazone by the U.S. Food and Drug Administration
    • Woodcock J, Sharfstein JM, Hamburg M. Regulatory action on rosiglitazone by the U.S. Food and Drug Administration. N Engl J Med 2010; 363(16): 1489-1491.
    • (2010) N Engl J Med , vol.363 , Issue.16 , pp. 1489-1491
    • Woodcock, J.1    Sharfstein, J.M.2    Hamburg, M.3
  • 12
    • 84867136659 scopus 로고    scopus 로고
    • FDA significantly restricts access to the diabetes drug Avandia. FDA, 9-23
    • FDA significantly restricts access to the diabetes drug Avandia. FDA, 9-23-2010.
    • (2010)
  • 13
    • 77954988618 scopus 로고    scopus 로고
    • Risk of acute myocardial infarction, stroke, heart failure, and death in elderly Medicare patients treated with rosiglitazone or pioglitazone
    • Graham DJ, Ouellet-Hellstrom R, MaCurdy TE, et al. Risk of acute myocardial infarction, stroke, heart failure, and death in elderly Medicare patients treated with rosiglitazone or pioglitazone. JAMA 2010; 304(4): 411-418.
    • (2010) JAMA , vol.304 , Issue.4 , pp. 411-418
    • Graham, D.J.1    Ouellet-Hellstrom, R.2    MaCurdy, T.E.3
  • 14
    • 84855596103 scopus 로고    scopus 로고
    • Potential Safety Signals and Their Significance
    • Powers A, Cook GE. Potential Safety Signals and Their Significance. Arch Intern Med 2012; 172: 72-73.
    • (2012) Arch Intern Med , vol.172 , pp. 72-73
    • Powers, A.1    Cook, G.E.2
  • 16
    • 84875005828 scopus 로고    scopus 로고
    • FDA. The Sentinel Initiative National Strategy for Monitoring Medical Product Safety. FDA,
    • FDA. The Sentinel Initiative National Strategy for Monitoring Medical Product Safety. FDA, 2008. http://www.fda.gov/downloads/Safety/FDAsSentinelInitiative/UCM124701.pdf
    • (2008)
  • 17
    • 84875005997 scopus 로고    scopus 로고
    • Drug Safety Information for Healthcare Professionals. FDA,
    • Drug Safety Information for Healthcare Professionals. FDA, 2010. http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/DrugSafetyInformationforHeathcareProfessionals/default.htm
    • (2010)


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.