-
1
-
-
84856962994
-
-
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
-
-
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
-
-
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
-
-
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and Boxed Warning Sections of Labeling for Human Prescription Drug and Biological Products-Content and Format DRAFT GUIDANCE, January, Accessed 23 February 2011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and Boxed Warning Sections of Labeling for Human Prescription Drug and Biological Products-Content and Format DRAFT GUIDANCE, January 2006.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
-
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
-
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
-
-
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
-
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
-
9
-
-
0036570099
-
Timing of new black box warnings and withdrawals for prescription medications
-
Lasser KE, Allen PD, Woolhandler SJ, Himmelstein DU, Wolfe SM, Bor DH. Timing of new black box warnings and withdrawals for prescription medications. JAMA 2002; 287:2215-2220. (Pubitemid 34441937)
-
(2002)
Journal of the American Medical Association
, vol.287
, Issue.17
, pp. 2215-2220
-
-
Lasser, K.E.1
Allen, P.D.2
Woolhandler, S.J.3
Himmelstein, D.U.4
Wolfe, S.M.5
Bor, D.H.6
-
10
-
-
0033596257
-
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
-
-
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
-
-
Droperidol [package insert]. Decatur, IL
-
Droperidol [package insert]. Taylor Pharmaceuticals. Decatur, IL. 2006.
-
(2006)
Taylor Pharmaceuticals
-
-
-
13
-
-
2442674314
-
"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
-
14
-
-
7144227313
-
A comparison of the efficacy, safety, and patient satisfaction of ondansetron versus droperidol as antiemetics for outpatient surgical procedures
-
DOI 10.1097/00000539-199804000-00011
-
Fortney JT, Gan TJ, Graczyk S, Wetchler B, Melson T, Khalil S, et al. A comparison of the effi cacy, safety, and patient satisfaction of ondansetron versus droperidol as antiemetics for elective outpatient surgical procedures. S3A-409 and S3A-410 Study Groups. Anesth Analg 1998; 86:731-738. (Pubitemid 28177723)
-
(1998)
Anesthesia and Analgesia
, vol.86
, Issue.4
, pp. 731-738
-
-
Fortney, J.T.1
Gan, T.J.2
Graczyk, S.3
Wetchler, B.4
Melson, T.5
Khalil, S.6
McKenzie, R.7
Parrillo, S.8
Glass, P.S.A.9
Moote, C.10
Wermeling, D.11
Parasuraman, T.V.12
Duncan, B.13
Creed, M.R.14
-
15
-
-
0033760954
-
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
-
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
-
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
-
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
-
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
-
21
-
-
0028104557
-
Droperidol causes a dose-dependent prolongation of the QT interval
-
Lischke V, Behne M, Doelken P, Schledt U, Probst S, Vettermann J. Droperidol causes a dose-dependent prolongation of the QT interval. Anesth Analg 1994; 79:983-986. (Pubitemid 24324682)
-
(1994)
Anesthesia and Analgesia
, vol.79
, Issue.5
, pp. 983-986
-
-
Lischke, V.1
Behne, M.2
Doelken, P.3
Schledt, U.4
Probst, S.5
Vettermann, J.6
-
22
-
-
0344375017
-
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
-
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
-
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
-
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
-
-
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
-
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
-
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
-
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
-
30
-
-
46749083807
-
Clinical pharmacology of methadone for pain
-
DOI 10.1111/j.1399-6576.2008.01597.x
-
Fredheim OM, Moksnes K, Borchgrevink PC, Kaasa S, Dale O. Clinical pharmacology of methadone for pain. Acta Anaesthesiol Scand 2008; 52:879-889. (Pubitemid 351951756)
-
(2008)
Acta Anaesthesiologica Scandinavica
, vol.52
, Issue.7
, pp. 879-889
-
-
Fredheim, O.M.S.1
Moksnes, K.2
Borchgrevink, P.C.3
Kaasa, S.4
Dale, O.5
-
31
-
-
42449123284
-
Interindividual variability of methadone response: Impact of genetic polymorphism
-
Li Y, Kantelip JP, Gerritsen-van SP, Davani S. Interindividual variability of methadone response: Impact of genetic polymorphism. Mol Diagn Ther 2008; 12:109-124. (Pubitemid 351570866)
-
(2008)
Molecular Diagnosis and Therapy
, vol.12
, Issue.2
, pp. 109-124
-
-
Li, Y.1
Kantelip, J.-P.2
Gerritsen-Van Schieveen, P.3
Davani, S.4
-
32
-
-
41549127146
-
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
-
33
-
-
67650491596
-
Methadone-induced mortality in the treatment of chronic pain: Role of QT prolongation
-
Andrews CM, Krantz MJ, Wedam EF, Marcuson MJ, Capacchione JF, Haigney MC. Methadone-induced mortality in the treatment of chronic pain: Role of QT prolongation. Cardiol J 2009; 16:210-217.
-
(2009)
Cardiol J
, vol.16
, pp. 210-217
-
-
Andrews, C.M.1
Krantz, M.J.2
Wedam, E.F.3
Marcuson, M.J.4
Capacchione, J.F.5
Haigney, M.C.6
-
34
-
-
34248588054
-
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
-
35
-
-
11444253334
-
QTc interval prolongation in patients on long-term methadone maintenance therapy
-
DOI 10.1159/000081416
-
Maremmani I, Pacini M, Cesaroni C, Lovrecic M, Perugi G, Tagliamonte A. QTc interval prolongation in patients on long-term methadone maintenance therapy. Eur Addict Res 2005; 11:44-49. (Pubitemid 40082210)
-
(2005)
European Addiction Research
, vol.11
, Issue.1
, pp. 44-49
-
-
Maremmani, I.1
Pacini, M.2
Cesaroni, C.3
Lovrecic, M.4
Perugi, G.5
Tagliamonte, A.6
-
36
-
-
28044463813
-
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
-
-
Methadone [package insert]. Roxane Laboratories, Inc. Columbus, OH.
-
Methadone [package insert]. Roxane Laboratories, Inc. Columbus, OH.
-
-
-
-
38
-
-
73949122010
-
-
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
-
-
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
-
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
-
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
|