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Volumn 81, Issue 3, 2010, Pages 298-303

FDA boxed warnings: How to prescribe drugs safely

Author keywords

[No Author keywords available]

Indexed keywords

ACETYLSALICYLIC ACID; ALCOHOL; AMIODARONE; ATENOLOL; ATOMOXETINE; BUMETANIDE; CERIVASTATIN; CISAPRIDE; CLOZAPINE; DULOXETINE; ENALAPRIL; ENALAPRIL MALEATE; ESTRADIOL; FENTANYL; FERROUS SULFATE; FLUOXETINE; FUROSEMIDE; GENTAMICIN; HYDROMORPHONE; IBUPROFEN; IRBESARTAN; LISINOPRIL; METOPROLOL; METRONIDAZOLE; NAPROXEN; PEMOLINE; PEMOLINE MAGNESIUM; PERGOLIDE; PERGOLIDE MESILATE; PIMECROLIMUS; PIOGLITAZONE; RALOXIFENE; ROFECOXIB; ROSIGLITAZONE; SALMETEROL XINAFOATE; TACROLIMUS; TEGASEROD; TELITHROMYCIN; TOBRAMYCIN; TROGLITAZONE; UNINDEXED DRUG; VALDECOXIB; VALSARTAN; ANTIINFECTIVE AGENT; BRONCHODILATING AGENT; DRUG DERIVATIVE; PHOSPHATE; PRESCRIPTION DRUG; QUINOLONE DERIVATIVE; SALBUTAMOL; SALMETEROL; SODIUM DIHYDROGEN PHOSPHATE;

EID: 77449115991     PISSN: 0002838X     EISSN: 0002838X     Source Type: Journal    
DOI: None     Document Type: Article
Times cited : (23)

References (29)
  • 1
    • 29544437699 scopus 로고    scopus 로고
    • Black box 101: How the Food and Drug Administration evaluates, communicates, and manages drug benefit/risk
    • Murphy S, Roberts R. "Black box" 101: How the Food and Drug Administration evaluates, communicates, and manages drug benefit/risk. J Allergy Clin Immunol. 2006;117(1):34-39.
    • (2006) J Allergy Clin Immunol , vol.117 , Issue.1 , pp. 34-39
    • Murphy, S.1    Roberts, R.2
  • 3
    • 77950267684 scopus 로고    scopus 로고
    • Accessed November 23, 2009
    • U.S. Food and Drug Administration. Adverse Event Reporting System (AERS) statistics. http://www.fda.gov/drugs/guidancecompliance regulatoryinformation/ surveillance/adversedrugeffects/ucm070093. htm. Accessed November 23, 2009.
    • Adverse Event Reporting System (AERS) statistics
  • 4
    • 85031342369 scopus 로고    scopus 로고
    • Tufts Center for the Study of Drug Development. Drug safety withdrawals in the U.S. not linked to speed of FDA approval. Tufts CSDD Impact Report. 2005;7(5):1-4. http://csdd.tufts.edu/InfoServices/Impact ReportsArchive.asp?subsection=2005 (subscription required). Accessed October 14, 2009.
    • Tufts Center for the Study of Drug Development. Drug safety withdrawals in the U.S. not linked to speed of FDA approval. Tufts CSDD Impact Report. 2005;7(5):1-4. http://csdd.tufts.edu/InfoServices/Impact ReportsArchive.asp?subsection=2005 (subscription required). Accessed October 14, 2009.
  • 5
    • 84996244370 scopus 로고    scopus 로고
    • Accessed October 14, 2009
    • U.S. Food and Drug Administration. Index to drug-specific information. http://www.fda.gov/cder/drug/DrugSafety/DrugIndex.htm. Accessed October 14, 2009.
    • Index to drug-specific information
  • 6
    • 85031340097 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. http://www.fda. gov/downloads/Drugs/ GuidanceComplianceRegulatoryInformation/ Guidances/ucm075096.pdf. Accessed November 24, 2009.
    • Guidance for Industry. Warnings and precautions, contraindications, and boxed warning sections of labeling for human prescription drug and biological products - content and format. http://www.fda. gov/downloads/Drugs/ GuidanceComplianceRegulatoryInformation/ Guidances/ucm075096.pdf. Accessed November 24, 2009.
  • 8
    • 77649217043 scopus 로고    scopus 로고
    • Proliferation of drugs with black-box warnings and required MedGuides, 220331, subscription required, Accessed December 23
    • Proliferation of drugs with black-box warnings and required MedGuides. Pharmacist's Letter/Prescriber's Letter. 2006;22(220331). http://www. prescribersletter.com (subscription required). Accessed December 23, 2009.
    • (2006) Pharmacist's Letter/Prescriber's Letter , pp. 22
  • 9
    • 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, Shuren JE, Hass AE, Thompson LJ. The safety of newly approved medicines: do recent market removals mean there is a problem? JAMA. 1999;281(18):1728-1734.
    • (1999) JAMA , vol.281 , Issue.18 , pp. 1728-1734
    • Friedman, M.A.1    Woodcock, J.2    Lumpkin, M.M.3    Shuren, J.E.4    Hass, A.E.5    Thompson, L.J.6
  • 10
    • 0031709689 scopus 로고    scopus 로고
    • Black box warnings in prescription drug labeling: Results of a survey of 206 drugs
    • 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(3):403-411.
    • (1998) Food Drug Law J , vol.53 , Issue.3 , pp. 403-411
    • Beach, J.E.1    Faich, G.A.2    Bormel, F.G.3    Sasinowski, F.J.4
  • 11
    • 58949102434 scopus 로고    scopus 로고
    • A comparison of sodium phosphosoda purgative to polyethylene glycol bowel preparations prior to colonoscopy
    • Brunelli SM, Feldman HI, Latif SM, Gupta M, Weiner MG, Lewis JD. A comparison of sodium phosphosoda purgative to polyethylene glycol bowel preparations prior to colonoscopy. Fam Med. 2009;41(1):39-45.
    • (2009) Fam Med , vol.41 , Issue.1 , pp. 39-45
    • Brunelli, S.M.1    Feldman, H.I.2    Latif, S.M.3    Gupta, M.4    Weiner, M.G.5    Lewis, J.D.6
  • 12
    • 33644875696 scopus 로고    scopus 로고
    • Acute phosphate nephropathy following oral sodium phosphate bowel purgative: An underrecognized cause of chronic renal failure
    • Markowitz GS, Stokes MB, Radhakrishnan J, D'Agati VD. Acute phosphate nephropathy following oral sodium phosphate bowel purgative: an underrecognized cause of chronic renal failure. J Am Soc Nephrol. 2005;16(11):3389-3396.
    • (2005) J Am Soc Nephrol , vol.16 , Issue.11 , pp. 3389-3396
    • Markowitz, G.S.1    Stokes, M.B.2    Radhakrishnan, J.3    D'Agati, V.D.4
  • 13
    • 41549107621 scopus 로고    scopus 로고
    • The effect of oral sodium phosphate drug products on renal function in adults undergoing bowel endoscopy
    • Khurana A, McLean L, Atkinson S, Foulks CJ. The effect of oral sodium phosphate drug products on renal function in adults undergoing bowel endoscopy. Arch Intern Med. 2008;168(6):593-597.
    • (2008) Arch Intern Med , vol.168 , Issue.6 , pp. 593-597
    • Khurana, A.1    McLean, L.2    Atkinson, S.3    Foulks, C.J.4
  • 14
    • 36749014050 scopus 로고    scopus 로고
    • The renal safety of bowel preparations for colonoscopy: A comparative study of oral sodium phosphate solution and polyethylene glycol
    • Singal AK, Rosman AS, Post JB, Bauman WA, Spungen AM, Korsten MA. The renal safety of bowel preparations for colonoscopy: a comparative study of oral sodium phosphate solution and polyethylene glycol. Aliment Pharmacol Ther. 2008;27(1):41-47.
    • (2008) Aliment Pharmacol Ther , vol.27 , Issue.1 , pp. 41-47
    • Singal, A.K.1    Rosman, A.S.2    Post, J.B.3    Bauman, W.A.4    Spungen, A.M.5    Korsten, M.A.6
  • 15
    • 36549001190 scopus 로고    scopus 로고
    • Risk of impaired renal function after colonoscopy: A cohort study in patients receiving either oral sodium phosphate or polyethylene glycol
    • Russmann S, Lamerato L, Marfatia A, et al. Risk of impaired renal function after colonoscopy: a cohort study in patients receiving either oral sodium phosphate or polyethylene glycol. Am J Gastroenterol. 2007;102(12):2655-2663.
    • (2007) Am J Gastroenterol , vol.102 , Issue.12 , pp. 2655-2663
    • Russmann, S.1    Lamerato, L.2    Marfatia, A.3
  • 16
    • 0034800321 scopus 로고    scopus 로고
    • Tendon disorders attributed to fluoroquinolones: A study on 42 spontaneous reports in the period 1988 to 1998
    • van der Linden PD, van Puijenbroek EP, Feenstra J, et al. Tendon disorders attributed to fluoroquinolones: a study on 42 spontaneous reports in the period 1988 to 1998. Arthritis Rheum. 2001;45(3):235-239.
    • (2001) Arthritis Rheum , vol.45 , Issue.3 , pp. 235-239
    • van der Linden, P.D.1    van Puijenbroek, E.P.2    Feenstra, J.3
  • 17
    • 33749439348 scopus 로고    scopus 로고
    • Evidence of tendinitis provoked by fluoroquinolone treatment: A case-control study
    • Corrao G, Zambon A, Bertù L, et al. Evidence of tendinitis provoked by fluoroquinolone treatment: a case-control study. Drug Saf. 2006;29(10):889-896.
    • (2006) Drug Saf , vol.29 , Issue.10 , pp. 889-896
    • Corrao, G.1    Zambon, A.2    Bertù, L.3
  • 18
    • 0037792114 scopus 로고    scopus 로고
    • Fluoroquinolone-associated tendinopathy: A critical review of the literature
    • Khaliq Y, Zhanel GG. Fluoroquinolone-associated tendinopathy: a critical review of the literature. Clin Infect Dis. 2003;36(11):1404-1410.
    • (2003) Clin Infect Dis , vol.36 , Issue.11 , pp. 1404-1410
    • Khaliq, Y.1    Zhanel, G.G.2
  • 19
    • 33144476873 scopus 로고    scopus 로고
    • Nelson HS, Weiss ST, Bleecker ER, Yancey SW, Dorinsky PM, for the SMART Study Group. The Salmeterol Multicenter Asthma Research Trial: a comparison of usual pharmacotherapy for asthma or usual pharmacotherapy plus salmeterol [published correction appears in Chest. 2006;129(5):1393]. Chest. 2006;129(1):15-26.
    • Nelson HS, Weiss ST, Bleecker ER, Yancey SW, Dorinsky PM, for the SMART Study Group. The Salmeterol Multicenter Asthma Research Trial: a comparison of usual pharmacotherapy for asthma or usual pharmacotherapy plus salmeterol [published correction appears in Chest. 2006;129(5):1393]. Chest. 2006;129(1):15-26.
  • 20
    • 33745306721 scopus 로고    scopus 로고
    • Meta-analysis: Effect of long-acting beta-agonists on severe asthma exacerbations and asthma-related deaths
    • Salpeter SR, Buckley NS, Ormiston TM, Salpeter EE. Meta-analysis: effect of long-acting beta-agonists on severe asthma exacerbations and asthma-related deaths. Ann Intern Med. 2006;144(12):904-912.
    • (2006) Ann Intern Med , vol.144 , Issue.12 , pp. 904-912
    • Salpeter, S.R.1    Buckley, N.S.2    Ormiston, T.M.3    Salpeter, E.E.4
  • 21
    • 57349199462 scopus 로고    scopus 로고
    • The safety of long-acting beta-agonists among patients with asthma using inhaled corticosteroids: Systematic review and metaanalysis
    • Jaeschke R, O'Byrne PM, Mejza F, et al. The safety of long-acting beta-agonists among patients with asthma using inhaled corticosteroids: systematic review and metaanalysis. Am J Respir Crit Care Med. 2008;178(10):1009-1016.
    • (2008) Am J Respir Crit Care Med , vol.178 , Issue.10 , pp. 1009-1016
    • Jaeschke, R.1    O'Byrne, P.M.2    Mejza, F.3
  • 22
    • 21844449700 scopus 로고    scopus 로고
    • Addition of inhaled long-acting beta2-agonists to inhaled steroids as first line therapy for persistent asthma in steroid-naive adults
    • CD005307
    • Ni CM, Greenstone IR, Ducharme FM. Addition of inhaled long-acting beta2-agonists to inhaled steroids as first line therapy for persistent asthma in steroid-naive adults. Cochrane Database Syst Rev. 2005;(2): CD005307.
    • (2005) Cochrane Database Syst Rev , Issue.2
    • Ni, C.M.1    Greenstone, I.R.2    Ducharme, F.M.3
  • 23
    • 33644873375 scopus 로고    scopus 로고
    • Long-acting beta2-agonists versus placebo in addition to inhaled corticosteroids in children and adults with chronic asthma
    • CD005535
    • Ni Chroinin M, Greenstone IR, Danish A, et al. Long-acting beta2-agonists versus placebo in addition to inhaled corticosteroids in children and adults with chronic asthma. Cochrane Database Syst Rev. 2005;(4): CD005535.
    • (2005) Cochrane Database Syst Rev , Issue.4
    • Ni Chroinin, M.1    Greenstone, I.R.2    Danish, A.3
  • 24
    • 18344409833 scopus 로고    scopus 로고
    • Regular treatment with long acting beta agonists versus daily regular treatment with short acting beta agonists in adults and children with stable asthma
    • CD003901
    • Walters EH, Walters JA, Gibson PW. Regular treatment with long acting beta agonists versus daily regular treatment with short acting beta agonists in adults and children with stable asthma. Cochrane Database Syst Rev. 2002;(4):CD003901.
    • (2002) Cochrane Database Syst Rev , Issue.4
    • Walters, E.H.1    Walters, J.A.2    Gibson, P.W.3
  • 25
    • 32644436054 scopus 로고    scopus 로고
    • Adherence to black box warnings for prescription medications in outpatients
    • Lasser KE, Seger DL, Yu DT, et al. Adherence to black box warnings for prescription medications in outpatients. Arch Intern Med. 2006;166(3):338-344.
    • (2006) Arch Intern Med , vol.166 , Issue.3 , pp. 338-344
    • Lasser, K.E.1    Seger, D.L.2    Yu, D.T.3
  • 26
    • 0035908725 scopus 로고    scopus 로고
    • Prescribing new drugs: Qualitative study of influences on consultants and general practitioners
    • Jones MI, Greenfield SM, Bradley CP. Prescribing new drugs: qualitative study of influences on consultants and general practitioners. BMJ. 2001;323(7309):378-381.
    • (2001) BMJ , vol.323 , Issue.7309 , pp. 378-381
    • Jones, M.I.1    Greenfield, S.M.2    Bradley, C.P.3
  • 27
    • 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. 2002;287(17):2273-2275.
    • (2002) JAMA , vol.287 , Issue.17 , pp. 2273-2275
    • Temple, R.J.1    Himmel, M.H.2
  • 28
    • 0347363549 scopus 로고    scopus 로고
    • STEPS drug updates [editorial]
    • Shaughnessy AF. STEPS drug updates [editorial]. Am Fam Physician. 2003;68(12):2213.
    • (2003) Am Fam Physician , vol.68 , Issue.12 , pp. 2213
    • Shaughnessy, A.F.1
  • 29
    • 85031344126 scopus 로고    scopus 로고
    • Drug Effectiveness Review Project DERP, Accessed October 14, 2009
    • Drug Effectiveness Review Project (DERP). http://www.ohsu.edu/ drugeffectiveness. Accessed October 14, 2009.


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.