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1
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58749086751
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The new Food and Drug Administration drug •• package insert: Implications for patient safety and clinical care
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Review of new drug labeling requirements by the FDA, as well as prescribing information on off-label use of drugs by physicians
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Watson KT, Barash PG. The new Food and Drug Administration drug •• package insert: implications for patient safety and clinical care. Anesth Analg 2009; 108: 211-218.
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(2009)
Anesth. Analg.
, vol.108
, pp. 211-218
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Watson, K.T.1
Barash, P.G.2
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2
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0036972176
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FDA use of the black box warning: Time for reevaluation as a safety •• tool [editorial]
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Excellent background on the legal aspects of the FDA BBW system. Droperidol is used as an example of the process
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Liang BA. FDA use of the black box warning: time for reevaluation as a safety •• tool [editorial]. J Clin Anesth 2002; 14: 561-563. Excellent background on the legal aspects of the FDA BBW system. Droperidol is used as an example of the process.
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(2002)
J. Clin. Anesth.
, vol.14
, pp. 561-563
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Liang, B.A.1
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3
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77952006305
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21 Code of Federal Regulations Sections 201.56, 201.57
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- 21 Code of Federal Regulations Sections 201.56, 201.57.
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4
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77951986994
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21 Code of Federal Regulations Section 201.57 e
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- 21 Code of Federal Regulations Section 201.57 (e).
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5
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77951980309
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Center for Drug Evaluation and Research. Warnings and precautions, contraindications, and boxed warning sections of labeling for human prescription drug and biological products - content and format. Guidance for industry. Rockville, MD: US Department of Health and Human Services; January
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Center for Drug Evaluation and Research. Warnings and precautions, contraindications, and boxed warning sections of labeling for human prescription drug and biological products - content and format. Guidance for industry. Rockville, MD: US Department of Health and Human Services; January 2006.
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(2006)
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6
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0031709689
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Black box warnings in prescription drug labeling: Results of a survey of 206 drugs
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Beach JE, Faich GA, Bormel FG, Sasinowski FJ. Black box warnings in prescription drug labeling: results of a survey of 206 drugs. Food Drug Law J 1998; 53: 403-411.
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(1998)
Food Drug Law J.
, vol.53
, pp. 403-411
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Beach, J.E.1
Faich, G.A.2
Bormel, F.G.3
Sasinowski, F.J.4
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7
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77951991738
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Product insert for droperidol. http://dailymed.nlm.nih.gov/dailymed/ drugInfo. cfm?id=2750 Accessed 17 December 2009
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Product insert for droperidol. http://dailymed.nlm.nih.gov/dailymed/ drugInfo. cfm?id=2750 [Accessed 17 December 2009].
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8
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0036968279
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Droperidol: Should the black box be light gray?
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Dershwitz M. Droperidol: should the black box be light gray? J Clin Anesth 2002; 14: 598-603.
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(2002)
J. Clin. Anesth.
, vol.14
, pp. 598-603
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Dershwitz, M.1
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10
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85046911746
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The FDA droperidol warning: Is it justified? [letter to editor]
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Norton R, Karan S, Baily P. The FDA droperidol warning: is it justified? [letter to editor]. Anesthesiology 2002; 97: 288-289.
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(2002)
Anesthesiology
, vol.97
, pp. 288-289
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Norton, R.1
Karan, S.2
Baily, P.3
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11
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0037407990
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Food and Drug Administration black box warning on the •• perioperative use of droperidol: A review of cases
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This study details the FDA review of the droperidol adverse event database and its implications for clinical practice
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Habib AS, Gan TJ. Food and Drug Administration black box warning on the •• perioperative use of droperidol: a review of cases. Anesth Analg 2003; 96: 1377-1379. This study details the FDA review of the droperidol adverse event database and its implications for clinical practice.
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(2003)
Anesth. Analg.
, vol.96
, pp. 1377-1379
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Habib, A.S.1
Gan, T.J.2
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12
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0037379661
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Droperidol QT prolongation and • sudden death: What is the evidence?
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Discussion of QT interval prolongation and development of TdeP. In addition, the authors review cases in droperidol adverse event database
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Kao LW, Kirk MA, Evers JS, Rosenfeld SH. Droperidol QT prolongation and • sudden death: what is the evidence? Ann Emerg Med 2003; 41: 546-558. Discussion of QT interval prolongation and development of TdeP. In addition, the authors review cases in droperidol adverse event database.
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(2003)
Ann. Emerg. Med.
, vol.41
, pp. 546-558
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Kao, L.W.1
Kirk, M.A.2
Evers, J.S.3
Rosenfeld, S.H.4
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13
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0036788030
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Droperidol: A cost-effective antiemetic for over thirty years [editor-• ial]
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Excellent overview of the cost-benefit risk associated with droperidol and the subsequent issuing of a BBW for the drug
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White PF. Droperidol: a cost-effective antiemetic for over thirty years [editor-• ial]. Anesth Analg 2002; 95: 789-790. Excellent overview of the cost-benefit (risk) associated with droperidol and the subsequent issuing of a BBW for the drug.
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(2002)
Anesth. Analg.
, vol.95
, pp. 789-790
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White, P.F.1
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14
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1442306232
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Drug-induced prolongation of the QT interval
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••, Comprehensive review of drug effect on prolongation of the QT interval
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Roden DM. Drug-induced prolongation of the QT interval. N Engl J Med 2004; •• 350: 1013-1022. Comprehensive review of drug effect on prolongation of the QT interval.
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(2004)
N. Engl. J. Med.
, vol.350
, pp. 1013-1022
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Roden, D.M.1
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15
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0036569927
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Safety of newly approved drugs: Implications for prescribing [editorial]
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Temple RJ, Himmel MH. Safety of newly approved drugs: implications for prescribing [editorial]. JAMA 2002; 287: 2273-2275.
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(2002)
JAMA
, vol.287
, pp. 2273-2275
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Temple, R.J.1
Himmel, M.H.2
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16
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42449099549
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PRO: The Food and Drug Administration black box • warning on droperidol is not justified [editorial]
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Review of recent events and literature for the BBW for droperidol. The authors conclude that the droperidol BBW should be removed due to lack of evidence for clinically significant prolongation of the QT interval
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Habib AS, Gan TJ. PRO: the Food and Drug Administration black box • warning on droperidol is not justified [editorial]. Anesth Analg 2008; 106: 1414-1417. Review of recent events and literature for the BBW for droperidol. The authors conclude that the droperidol BBW should be removed due to lack of evidence for clinically significant prolongation of the QT interval.
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(2008)
Anesth. Analg.
, vol.106
, pp. 1414-1417
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Habib, A.S.1
Gan, T.J.2
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17
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0032993993
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Comparative efficacy and •• safety of ondansetron, droperidol, and metoclopramide for preventing postoperative nausea and vomiting: A meta-analysis
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Clinically relevant and scientifically valid meta-analysis for a large number of series comparing ondansetron, droperidol and metoclopramide
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Domino KB, Anderson EA, Polissar NL, Posner KL. Comparative efficacy and •• safety of ondansetron, droperidol, and metoclopramide for preventing postoperative nausea and vomiting: a meta-analysis. Anesth Analg 1999; 88: 1370-1379. Clinically relevant and scientifically valid meta-analysis for a large number of series comparing ondansetron, droperidol and metoclopramide.
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(1999)
Anesth. Analg.
, vol.88
, pp. 1370-1379
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Domino, K.B.1
Anderson, E.A.2
Polissar, N.L.3
Posner, K.L.4
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18
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34748849489
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Does low-dose droperidol admin-•• istration increase the risk of drug-induced QT prolongation and Torsade de Pointes in the general surgical population?
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Single, large academic medical center experience with QT interval and TdeP before and after the FDA droperidol BBW
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Nuttall GA, Eckleman KM, Jacob KA, et al. Does low-dose droperidol admin-•• istration increase the risk of drug-induced QT prolongation and Torsade de Pointes in the general surgical population? Anesthesiology 2007; 107: 531-536. Single, large academic medical center experience with QT interval and TdeP before and after the FDA droperidol BBW.
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(2007)
Anesthesiology
, vol.107
, pp. 531-536
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Nuttall, G.A.1
Eckleman, K.M.2
Jacob, K.A.3
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19
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40749154367
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The use of droperidol before and after the Food and Drug • Administration black box warning: A survey of members of the Society of Ambulatory Anesthesia
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An important survey documenting practice patterns for PONV before and after the FDA issued the droperidol BBW
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Habib AS, Gan TJ. The use of droperidol before and after the Food and Drug • Administration black box warning: a survey of members of the Society of Ambulatory Anesthesia. J Clin Anesth 2008; 20: 35-39. An important survey documenting practice patterns for PONV before and after the FDA issued the droperidol BBW.
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(2008)
J. Clin. Anesth.
, vol.20
, pp. 35-39
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Habib, A.S.1
Gan, T.J.2
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20
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42449130116
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Con: The Food and Drug Administration black box •• warning on droperidol is not justified (but should be clarified!)
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editorial, An excellent review of the biological and clinical aspects of the clinical use of droperidol and the implication of the FDA droperidol BBW
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Ludwin DB, Shafer SL. Con: the Food and Drug Administration black box •• warning on droperidol is not justified (but should be clarified!) [editorial]. Anesth Analg 2008; 106: 1418-1420. An excellent review of the biological and clinical aspects of the clinical use of droperidol and the implication of the FDA droperidol BBW.
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(2008)
Anesth. Analg.
, vol.106
, pp. 1418-1420
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Ludwin, D.B.1
Shafer, S.L.2
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21
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42449104388
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FDA response to droperidol black box warning editorials [letter to editor]
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Rappaport BA. FDA response to droperidol black box warning editorials [letter to editor]. Anesth Analg 2008; 106: 1585.
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(2008)
Anesth. Analg.
, vol.106
, pp. 1585
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Rappaport, B.A.1
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22
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10744225134
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Consensus guidelines for managing post •• operative nausea and vomiting
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Current recommendations for the management of PONV by an international panel of experts
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Gan TJ, Meyer T, Apfel CC, et al. Consensus guidelines for managing post •• operative nausea and vomiting. Anesth Analg 2003; 97: 62-71. Current recommendations for the management of PONV by an international panel of experts.
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(2003)
Anesth. Analg.
, vol.97
, pp. 62-71
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Gan, T.J.1
Meyer, T.2
Apfel, C.C.3
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23
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77951999594
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President Interim Report American Society of Anesthesiologists March 8, Section 1.1.5
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President Interim Report American Society of Anesthesiologists March 8 2009. Section 1.1.5.
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(2009)
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