메뉴 건너뛰기




Volumn 49, Issue 6, 2011, Pages 443-447

A continuing black hole? the FDA boxed warning: An appeal to improve its clinical utility

Author keywords

Adverse drug reaction; FDA; Recall

Indexed keywords

AMFEBUTAMONE; BROMFENAC; CISAPRIDE; DROPERIDOL; FELBAMATE; FENTANYL; METHADONE; METOCLOPRAMIDE; QUINOLINE DERIVED ANTIINFECTIVE AGENT; WARFARIN; ZOMEPIRAC;

EID: 80051779618     PISSN: 15563650     EISSN: 15569519     Source Type: Journal    
DOI: 10.3109/15563650.2011.564585     Document Type: Review
Times cited : (12)

References (41)
  • 1
    • 84856962994 scopus 로고    scopus 로고
    • Associated Press, FDA ' s drug approvals flat in 2009, safety up, Accessed 23 February 2011
    • Associated Press 2009. FDA ' s drug approvals flat in 2009, safety up, http://www.msnbc.msn.com/id/34708085/ns/health-more-health-news/. Accessed 23 February 2011.
    • (2009)
  • 2
    • 80051750870 scopus 로고    scopus 로고
    • Food and Drug Administration (FDA) 1979. 21 Code of Federal Regulations xx201.56, 201.57
    • Food and Drug Administration (FDA) 1979. 21 Code of Federal Regulations xx201.56, 201.57.
  • 3
    • 80051743521 scopus 로고    scopus 로고
    • Food and Drug Administration (FDA) 1979. 21 Code of Federal Regulations x201.57(e)
    • Food and Drug Administration (FDA) 1979. 21 Code of Federal Regulations x201.57(e).
  • 4
    • 84856963001 scopus 로고    scopus 로고
    • Guidance for Industry Warnings and Precautions, Contraindications, and Boxed Warning Sections of Labeling for Human Prescription Drug and Biological Products-Content and Format DRAFT GUIDANCE, January, Accessed 23 February 2011
    • Guidance for Industry Warnings and Precautions, Contraindications, and Boxed Warning Sections of Labeling for Human Prescription Drug and Biological Products-Content and Format DRAFT GUIDANCE, January 2006. http://www.fda.gov/ downloads/ Drugs/ GuidanceComplianceRegulatoryInformation/Guidances/ ucm075096. pdf. Accessed 23 February 2011.
    • (2006)
  • 5
    • 0036972176 scopus 로고    scopus 로고
    • FDA use of the black box warning: Time for reevaluation as a safety tool
    • DOI 10.1016/S0952-8180(02)00444-0
    • Liang BA. FDA use of the black box warning: Time for reevaluation as a safety tool. J Clin Anesth 2002; 14:561-563. (Pubitemid 36143655)
    • (2002) Journal of Clinical Anesthesia , vol.14 , Issue.8 , pp. 561-563
    • Liang, B.A.1
  • 6
    • 0034660474 scopus 로고    scopus 로고
    • Thrombotic thrombocytopenic purpura and clopidogrel - A need for new approaches to drug safety
    • DOI 10.1056/NEJM200006153422410
    • Wood AJ. Thrombotic thrombocytopenic purpura and clopidogrel-a need for new approaches to drug safety. N Engl J Med 2000; 342: 1824-1826. (Pubitemid 30390244)
    • (2000) New England Journal of Medicine , vol.342 , Issue.24 , pp. 1824-1826
    • Wood, A.J.J.1
  • 7
    • 84856958239 scopus 로고    scopus 로고
    • Food and Drug Administration (FDA) Dr. Curtis Rosebraugh (Director of Drug Evaluation II in the Center for Drug Evaluation and Research at FDA) from the Transcript for FDA ' s Media Briefi ng on the Serious Mental Health Risks Associated with the Drugs Chantix and Zyban, 1 July 2009. Accessed 23 February 2011
    • Food and Drug Administration (FDA) 2009. Dr. Curtis Rosebraugh (Director of Drug Evaluation II in the Center for Drug Evaluation and Research at FDA) from the Transcript for FDA ' s Media Briefi ng on the Serious Mental Health Risks Associated with the Drugs Chantix and Zyban, 1 July 2009. www.fda.gov/downloads/News Events/Newsroom/Media/transcripts. Accessed 23 February 2011.
    • (2009)
  • 8
    • 70349972263 scopus 로고    scopus 로고
    • Risk management policy and black-box warnings: A qualitative analysis of US FDA proceedings
    • Cook DM, Gurugubelli RK, Bero LA. Risk management policy and black-box warnings: A qualitative analysis of US FDA proceedings. Drug Saf 2009; 32:1057-1066.
    • (2009) Drug Saf , vol.32 , pp. 1057-1066
    • Cook, D.M.1    Gurugubelli, R.K.2    Bero, L.A.3
  • 10
    • 0033596257 scopus 로고    scopus 로고
    • Safety of FDA-approved drugs
    • Lurie P, Sasich LD. Safety of FDA-approved drugs. JAMA 1999; 282:2297-2298.
    • (1999) JAMA , vol.282 , pp. 2297-2298
    • Lurie, P.1    Sasich, L.D.2
  • 11
    • 84856963004 scopus 로고    scopus 로고
    • Safety Alerts for Human Medical Products, FDA, U.S. Department of Health and Human Services. Accessed 23 February 2011
    • -2006 Safety Alerts for Human Medical Products, FDA, U.S. Department of Health and Human Services. www.fda.gov/safety/ Med-Watch/SafetyInformation/ SafetyAlertsforHumanMedicalProducts/. Accessed 23 February 2011.
    • (2006)
  • 12
    • 80051715210 scopus 로고    scopus 로고
    • Droperidol [package insert]. Decatur, IL
    • Droperidol [package insert]. Taylor Pharmaceuticals. Decatur, IL. 2006.
    • (2006) Taylor Pharmaceuticals
  • 13
    • 2442674314 scopus 로고    scopus 로고
    • "Black box" warning on droperidol: A report of the FDA convened expert panel [1]
    • Gan TJ. " Black box' warning on droperidol: Report of the FDA convened expert panel. Anesth Analg 2004; 98:1809. (Pubitemid 38668940)
    • (2004) Anesthesia and Analgesia , vol.98 , Issue.6 , pp. 1809
    • Gan, T.J.1
  • 15
    • 0033760954 scopus 로고    scopus 로고
    • Efficacy dose-response and adverse effects of droperidol for prevention of postoperative nausea and vomiting
    • Henzi I, Sonderegger J, Tramer MR. Efficacy, dose-response, and adverse effects of droperidol for prevention of postoperative nausea and vomiting. Can J Anaesth 2000; 47:537-551.
    • (2000) Can J Anaesth , vol.47 , pp. 537-551
    • Henzi, I.1    Sonderegger, J.2    Tramer, M.R.3
  • 16
    • 0036307482 scopus 로고    scopus 로고
    • The FDA droperidol warning: Is it justified?
    • Bailey P, Norton R, Karan S. The FDA droperidol warning: Is it justified? Anesthesiology 2002; 97:288-289.
    • (2002) Anesthesiology , vol.97 , pp. 288-289
    • Bailey, P.1    Norton, R.2    Karan, S.3
  • 17
    • 0011899739 scopus 로고    scopus 로고
    • FDA "black box" warning regarding use of droperidol for postoperative nausea and vomiting: Is it justified? [11]
    • DOI 10.1097/00000542-200207000-00059
    • Gan TJ, White PF, Scuderi PE, Watcha MF, Kovac A. FDA " black box " warning regarding use of droperidol for postoperative nausea and vomiting: Is it justified? Anesthesiology 2002; 97:287. (Pubitemid 34733963)
    • (2002) Anesthesiology , vol.97 , Issue.1 , pp. 287
    • Gan, T.J.1    White, P.F.2    Scuderi, P.E.3    Watcha, M.F.4    Kovac, A.5
  • 18
    • 0037407990 scopus 로고    scopus 로고
    • Food and drug administration black box warning on the perioperative use of droperidol: A review of the cases
    • Habib AS, Gan TJ. Food and drug administration black box warning on the perioperative use of droperidol: A review of the cases. Anesth Analg 2003; 96:1377-1379. (Pubitemid 36512879)
    • (2003) Anesthesia and Analgesia , vol.96 , Issue.5 , pp. 1377-1379
    • Habib, A.S.1    Gan, T.J.2
  • 20
    • 0037379661 scopus 로고    scopus 로고
    • Droperidol, QT prolongation, and sudden death: What is the evidence?
    • Kao LW, Kirk MA, Evers SJ, Rosenfeld SH. Droperidol, QT prolongation, and sudden death: What is the evidence? Ann Emerg Med 2003; 41:546-558.
    • (2003) Ann Emerg Med , vol.41 , pp. 546-558
    • Kao, L.W.1    Kirk, M.A.2    Evers, S.J.3    Rosenfeld, S.H.4
  • 22
    • 0344375017 scopus 로고    scopus 로고
    • QT lengthening after parenteral droperidol administration
    • Smith SW, Martel M, Biros M. QT lengthening after parenteral droperidol administration. Acad Emerg Med 2002; 9:374-375.
    • (2002) Acad Emerg Med , vol.9 , pp. 374-375
    • Smith, S.W.1    Martel, M.2    Biros, M.3
  • 23
    • 80051731457 scopus 로고    scopus 로고
    • Droperidol and the blackbox
    • (abstract).
    • Mieckowski A, Burns M. Droperidol and the Blackbox. Clin Toxicol (Phila) 2005; 40:669-670 (abstract).
    • (2005) Clin Toxicol (Phila) , vol.40 , pp. 669-670
    • Mieckowski, A.1    Burns, M.2
  • 24
    • 40749154367 scopus 로고    scopus 로고
    • The use of droperidol before and after the Food and Drug Administration black box warning: A survey of the members of the Society of Ambulatory Anesthesia
    • DOI 10.1016/j.jclinane.2007.08.003, PII S095281800700342X
    • Habib AS, Gan TJ. The use of droperidol before and after the Food and Drug Administration black box warning: A survey of the members of the Society of Ambulatory Anesthesia. J Clin Anesth 2008; 20:35-39. (Pubitemid 351381411)
    • (2008) Journal of Clinical Anesthesia , vol.20 , Issue.1 , pp. 35-39
    • Habib, A.S.1    Gan, T.J.2
  • 25
    • 34748849489 scopus 로고    scopus 로고
    • Does low-dose droperidol administration increase the risk of drug-induced QT prolongation and torsade de pointes in the general surgical population?
    • DOI 10.1097/01.anes.0000281893.39781.64, PII 0000054220071000000006
    • Nuttall GA, Eckerman KM, Jacob KA, Pawlaski EM, Wigersma SK, Marienau ME, et al. Does low-dose droperidol administration increase the risk of drug-induced QT prolongation and torsade de pointes in the general surgical population? Anesthesiology 2007; 107:531-536. (Pubitemid 47480557)
    • (2007) Anesthesiology , vol.107 , Issue.4 , pp. 531-536
    • Nuttall, G.A.1    Eckerman, K.M.2    Jacob, K.A.3    Pawlaski, E.M.4    Wigersma, S.K.5    Marienau, M.E.S.6    Oliver, W.C.7    Narr, B.J.8    Ackerman, M.J.9
  • 26
    • 80051718533 scopus 로고    scopus 로고
    • Methadone-associated Deaths and Efforts to Prevent Them. Government Accountability Office Report to Congressional Requesters: GAO-09-341; March, 2009
    • Methadone-associated Deaths and Efforts to Prevent Them. Government Accountability Office Report to Congressional Requesters: GAO-09-341; March, 2009.
  • 27
    • 68249124120 scopus 로고    scopus 로고
    • A comparison of drug overdose deaths involving methadone and other opioid analgesics in West Virginia
    • Paulozzi LJ, Logan JE, Hall AJ, McKinstry E, Kaplan JA, Crosby AE. A comparison of drug overdose deaths involving methadone and other opioid analgesics in West Virginia. Addiction 2009; 104: 1541-1548.
    • (2009) Addiction , vol.104 , pp. 1541-1548
    • Paulozzi, L.J.1    Logan, J.E.2    Hall, A.J.3    McKinstry, E.4    Kaplan, J.A.5    Crosby, A.E.6
  • 28
    • 34547523325 scopus 로고    scopus 로고
    • Surveillance of methadone-related adverse drug events using multiple public health data sources
    • DOI 10.1016/j.jbi.2006.10.004, PII S1532046406001158
    • Sims SA, Snow LA, Porucznik CA. Surveillance of methadonerelated adverse drug events using multiple public health data sources. J Biomed Inform 2007; 40:382-389. (Pubitemid 47187788)
    • (2007) Journal of Biomedical Informatics , vol.40 , Issue.4 , pp. 382-389
    • Sims, S.A.1    Snow, L.A.2    Porucznik, C.A.3
  • 29
    • 34249892158 scopus 로고    scopus 로고
    • Surveillance of prescription drug-related mortality using death certificate data
    • DOI 10.2165/00002018-200730060-00007
    • Wysowski DK. Surveillance of prescription drug-related mortality using death certificate data. Drug Saf 2007; 30:533-540. (Pubitemid 46873078)
    • (2007) Drug Safety , vol.30 , Issue.6 , pp. 533-540
    • Wysowski, D.K.1
  • 32
    • 41549127146 scopus 로고    scopus 로고
    • Actual and potential drug interactions associated with methadone
    • DOI 10.1111/j.1526-4637.2006.00289.x
    • Weschules DJ, Bain KT, Richeimer S. Actual and potential drug interactions associated with methadone. Pain Med 2008; 9: 315-344. (Pubitemid 351467888)
    • (2008) Pain Medicine , vol.9 , Issue.3 , pp. 315-344
    • Weschules, D.J.1    Bain, K.T.2    Richeimer, S.3
  • 34
    • 34248588054 scopus 로고    scopus 로고
    • Methadone-associated long QT syndrome: Improving pharmacotherapy for dependence on illegal opioids and lessons learned for pharmacology
    • DOI 10.1517/14740338.6.3.289
    • Ehret GB, Desmeules JA, Broers B. Methadone-associated long QT syndrome: Improving pharmacotherapy for dependence on illegal opioids and lessons learned for pharmacology. Expert Opin Drug Saf 2007; 6:289-303. (Pubitemid 46767636)
    • (2007) Expert Opinion on Drug Safety , vol.6 , Issue.3 , pp. 289-303
    • Ehret, G.B.1    Desmeules, J.A.2    Broers, B.3
  • 36
    • 28044463813 scopus 로고    scopus 로고
    • QT prolongation and torsades de pointes among methadone users: Reports to the FDA spontaneous reporting system
    • DOI 10.1002/pds.1112
    • Pearson EC, Woosley RL. QT prolongation and torsades de pointes among methadone users: Reports to the FDA spontaneous reporting system. Pharmacoepidemiol Drug Saf 2005; 14:747-753. (Pubitemid 41684467)
    • (2005) Pharmacoepidemiology and Drug Safety , vol.14 , Issue.11 , pp. 747-753
    • Pearson, E.C.1    Woosley, R.L.2
  • 37
    • 80051735401 scopus 로고    scopus 로고
    • Methadone [package insert]. Roxane Laboratories, Inc. Columbus, OH.
    • Methadone [package insert]. Roxane Laboratories, Inc. Columbus, OH.
  • 38
    • 73949122010 scopus 로고    scopus 로고
    • 2008, Annual Report of the American Association of Poison Control Centers ' National Poison Data System (NPDS): 26th Annual Report.
    • Bronstein AC, Spyker DA, Cantilena LR Jr., Green JL, Rumack BH, Giffin SL. 2008. Annual Report of the American Association of Poison Control Centers ' National Poison Data System (NPDS): 26th Annual Report. Clin Toxicol (Phila) 2009; 47:911-1084.
    • (2009) Clin Toxicol (Phila) , vol.47 , pp. 911-1084
    • Bronstein, A.C.1    Spyker, D.A.2    Cantilena Jr., L.R.3    Green, J.L.4    Rumack, B.H.5    Giffin, S.L.6
  • 39
    • 0034858137 scopus 로고    scopus 로고
    • 2000. Annual report of the American Association of Poison Control Centers Toxic Exposure Surveillance System
    • Litovitz TL, Klein-Schwartz W, White S, Cobaugh DJ, Youniss J, Omslaer JC, et al. 2000. Annual report of the American Association of Poison Control Centers Toxic Exposure Surveillance System. Am J Emerg Med 2001; 19:337-395.
    • (2001) Am J Emerg Med , vol.19 , pp. 337-395
    • Litovitz, T.L.1    Klein-Schwartz, W.2    White, S.3    Cobaugh, D.J.4    Youniss, J.5    Omslaer, J.C.6
  • 40
    • 38349081453 scopus 로고    scopus 로고
    • Physician awareness of the cardiac effects of methadone: Results of a national survey
    • Krantz MJ, Rowan SB, Schmittner J, Bucher BB. Physician awareness of the cardiac effects of methadone: Results of a national survey. J Addict Dis 2007; 26:79-85.
    • (2007) J Addict Dis , vol.26 , pp. 79-85
    • Krantz, M.J.1    Rowan, S.B.2    Schmittner, J.3    Bucher, B.B.4
  • 41
    • 0142243310 scopus 로고    scopus 로고
    • There Should Be a Threshold Dose for the FDA Black-Box Warning on Droperidol [2] (multiple letters)
    • Dershwitz, M. There should be a threshold dose for FDA black-box warning on droperidol. Anesth Analg. 2003; 97:1542-1543; author reply 1543. (Pubitemid 37310168)
    • (2003) Anesthesia and Analgesia , vol.97 , Issue.5 , pp. 1542-1543
    • Dershwitz, M.1    Habib, A.S.2    Gan, T.J.3


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.