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http://www.adis.com/files/newsletters/INP/Icov1429.pdf
20 Antipsychotics (atypical, long- acting): guidelines on use 3 Statins: intensive dosage regimen preferable 15 Escitalopram continuation prevents depression relapse 15 New British guidelines simplify hypertension treatment 4 Modafinil improved energy levels in chronic fatigue syndrome 16 Olanzapine/ risperidone not for use in elderly with dementia 21 ENDOCRINOLOGY Paroxetine: UK CSM...
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Preventable Adverse Drug Reactions: A focus on drug interactions
Food and Drug Administration • Center for Drug Evaluation and Research Drug Information Search Preventable Adverse Drug Reactions:-- A Focus on Drug Interactions This learning module was developed based on a needs survey sent to all third year medicine clerkship directors and all medicine residency program directors in the United States.- This module was developed by the Center...
author: OPDRA
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CDER Report to the Nation: 2002; Drug Safety and Quality
Food and Drug Administration • Center for Drug Evaluation and Research About CDER - Report Search CDER Report to the Nation: 2002 Table of Contents Adobe Acrobat version of this document Drug Safety and Quality Index Mission Highlights Types of Risks from Medicines Drug Safety MedWatch Outreach and Reporting Medication Guides Drug Shortages Drug Recalls and Withdrawals Recalls...
author: OLIVERN
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CDER Report to the Nation: 2000; Drug Safety and Quality
Food and Drug Administration • Center for Drug Evaluation and Research About CDER - Report Search CDER Report to the Nation: 2000 Table of Contents Drug Safety and Quality The practical size of premarketing clinical trials means that we cannot learn everything about the safety of a drug before we approve it
benefits 543 NMEs approved 14 withdrawn 2.6 percent withdrawn Recent...
author: OLIVERN
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Tuesday
Food and Drug Administration • Center for Drug Evaluation and Research Liver Toxicity Search Drug-Induced Liver Injury: A National and Global Problem 12-13 February 2001, Westfields Conference Center, Chantilly VA Final Program Tuesday, February 13, 2001 Invited Presentations Current Topics in Hepatology How are these problems being addressed in Europe
An estimated 3,000...
author: John Senior
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Drug Induced Liver Toxicity
Food and Drug Administration • Center for Drug Evaluation and Research Liver Toxicity Search Drug-Induced Liver Injury: A National and Global Problem 12-13 February 2001, Westfields Conference Center, Chantilly VA Final Program Monday, February 12, 2001 Invited Presentations Opening talks - Overview Welcome, Program Structure, Goals of the Conference and Workshop -- John Senior,...
author: John Senior
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CDER Report to the Nation: 2001
Food and Drug Administration • Center for Drug Evaluation and Research About CDER - Report Search CDER Report to the Nation: 2001 Table of Contents Drug Safety and Quality Index Mission Highlights Types of Risks from Medicines Drug Safety MedWatch Outreach and Reporting Drug Shortages Cyber Letters for Foreign Ciprofloxacin Drug-induced liver injury Drug Promotion Review Drug...
author: OLIVERN
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From Test Tube to Patient: Improving Health Through Human Drugs page 55
author: CDER/OTCOM
subject: Drug Information for the Consumer
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http://www.fda.gov/cder/otcmonographs/Internal_Analgesic/int_analgesic_TFM_amendment_20020821.htm
[Federal Register: August 21, 2002 (Volume 67, Number 162)] [Proposed Rules] [Page 54139-54159] From the Federal Register Online via GPO Access [wais.access.gpo.gov] [DOCID:fr21au02-21] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Parts 201 and 343 [Docket No
\2\ A = aspirin; AP ...
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Document page 19
author: U.S. Government Printing Office
subject: Extracted Pages
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Document page 11
author: U.S. Government Printing Office
subject: Extracted Pages
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Microsoft PowerPoint - Risk I - Tony Fox
Phenylpropanolamine Cisapride Terfenadine Astemizole Fenfluramine Bromfenac Mibefradil Troglitazone Alosetron Trovafloxacin Rotavirus vaccine Calendar Year Mean and range of product longevit y ( y ) 1998 1999 2000 2 4 6 8 1997 N = 3 N = 3 N = 3 N = 3 (Excludes PPA: no clear introduction date [ < 1970] ) OBSERVATIONS # 1: All required large patient exposures to become evident ...
author: Pamela Putz
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Microsoft PowerPoint - Risk I - Tony Fox page 12
author: Pamela Putz
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Microsoft PowerPoint - Risk I - Tony Fox page 6
author: Pamela Putz
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21 CFR 211 page 21
author: CBER / FDA
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Characterization of New Drug’s Safety Profile Before Marketing
Characterization of New Drug’s Safety Profile Before Marketing Friedman MA et al
JAMA 1999; 281(18):1728–1734 Most drugs approved by FDA with average of 1500 patient exposures Some drugs have rare toxicity profiles (bromfenac hepatotoxicity 1 in 20,000 patients) For drugs with rare toxicity, more than 100,000 patients must be exposed to generate a signal i.e
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Direct-to-consumer advertising of prescription medicines: a review of international policy and evidence
Direct- to- consumer advertising of prescription medicines: a review of international policy and evidence Supplement to a report for the Royal Pharmaceutical Society of Great Britain by Colin Meek November 2001 Recent Developments in DTCA November 2001 © Royal Pharmaceutical Society of Great Britain 2001 1.0 The issue of the safety of new medicines is discussed this month in the...
author: Authorised User
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Direct-to-consumer advertising of prescription medicines: a review of international policy and evidence page 1
author: Authorised User
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PPT Slide
PPT Slide Comparison of ALF Drug-Induced Cases 98-00 (n=28) Bromfenac Troglitazone INH Other (n = 4) (n = 4) (n = 4) (n = 16) Female (%) 100 50 50 75 Age 45 58 25 43 Spont surv’l 0 0 1 4 Transpl’t 3 3 2 8 Over’l surv’l 3 2 3 10 Other drugs (one each): DDI, disulfiram, halothane, isoflurane, itraconazole, methyldopa, nitrofurantoin, phenytoin,.pravastatin,...
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Explore and Develop Active/Sentinel Surveillance Strategies for Drug-Induced Liver Injury
Explore and Develop Active/Sentinel Surveillance Strategies for Drug-Induced Liver Injury Objectives: Earlier detection, better quantification, incidence/rate assessment, subject material for determination of mechanism(s) of drug-induced liver injury Strategies Start with retrospective evaluation of existing systems to detect/quantify true + events (bromfenac, troglitazone, etc...
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IDENTIFICATION OF IDIOSYNCRATIC HEPATOTOXICITY IN CLINICAL TRIALS
IDENTIFICATION OF IDIOSYNCRATIC HEPATOTOXICITY IN CLINICAL TRIALS Sample size and duration of exposure - no overt disease in 3000 indicates incidence ə:1000 Monitoring and stopping rules in clinical trials Selected study population – e.g
exclusion of liver disease Historical data Dangerous drugs – troglitazone, bromfenac, INH, etc
False alarms –...
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CLINICO-PATHOLOGICAL SIGNATURE OF DRUG-INDUCED LIVER DISEASES
CLINICO-PATHOLOGICAL SIGNATURE OF DRUG-INDUCED LIVER DISEASES Acute hepatitis - Acetaminophen, isoniazid, troglitazone, bromfenac Chronic hepatitis - Nitrofurantoin, methyldopa, diclofenac, minocycline, dantrolene Acute cholestasis - Amoxicillin/clavulanic acid, erythromycins, sulindac, chlorpromazine, ACE inhibitors Mixed pattern or atypical hepatitis - Phenytoin, sulfonamides...
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Hy’s Law and Current Practice: A hypothesis in use
Hy’s Law and Current Practice: A hypothesis in use If elevated TA to, say, 2-3% or greater, look at rate of bilirubin elevation to, say > 1.5 X ULN Assume rate of this combination is about 0.1 X rate of serious injury (Ballpark for bromfenac, troglitizone, isoniazid, etc) Previous slide Next slide Back to first slide View graphic version Hy’s Law and Current...
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Why TA plus Bilirubin
Why TA plus Bilirubin 1
Theory: hepatocellular injury sufficient to impair bilirubin excretion must be extensive 2
Observation: “Hy’s Law” About 10% of patients with elevated TA and jaundice will have serious/fatal hepatic necrosis 3
Cases: a
Liver injury: isonazid, iproniazid, dantrolene, ticrynafen, troglitizone, bromfenac, dilevalol b
No liver...
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PPT Slide
PPT Slide Hepatotoxicity has been the most common single adverse effect causing major drug problems (withdrawal after marketing or non-approval) Iproniazid (MARSILID?) - 1956 Ibufenac (in Europe only) - 1975 Ticrynafen (SELACRYN?) - 1979 Benoxaprofen (ORAFLEX?) - 1982 Perihexilene (in France) - 1985 Dilevalol (in Portugal, Ireland) - 1990 Bromfenac (DURACT?) - 1998 Troglitazone...
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