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1 Vol.2 o.8 (2004/04/22) 2004 [ Clozaril ] clozapine DA [ Abilify ] aripiprazole DA.3 ealth Canada.4 Canadian Adverse Reaction ewsletter Vol.14 o.2 April 2004 ealth Canada Sterol sterolin [ Plavix ] clopidogrel.9 Prescriber Update Articles Z MEDSAE.9 CX SSRI.13 MRA DA 1. DA MedWatch Web 2004/04/ /04/ Safety Alert : [ Clozaril ] clozapine ovartis [ Clozaril ] clozapine DA 1
2 DA [ Clozaril ] DA ovartis [ Clozaril ] [ Clozaril ] ovartis [ Clozaril ] Cl C 3 Clozapine MARTA multi acting receptor targeted agents 2004/04/08 2
3 2. DA MedWatch Web 2004/04/ /03/ Safety Alert : [ Abilify ] aripiprazole DA [ Abilify ] aripiprazole [ Abilify ] [ Abilify ] [ Abilify ] [ Abilify ] [ Abilify ] [ Abilify ] [ Abilify ] [ Abilify ] [ Abilify ] 1 1kg MS TD [ Abilify ] aripiprazole [ Abilify ] [ Abilify ] 0.1 [ Abilify ] 3
4 [ Abilify ] 10 [ Abilify ] 32% vs 25% 25% vs 24% 24% vs 19% 14% vs 10% 12% vs 7% 11% vs 8% 11% vs 7% 10% vs 7% 10% vs 8% Cl Cl Aripiprazole 2004/04/08 ealth Canada 1. Public pinion Survey on Key Issues Pertaining to Post-market Surveillance of Marketed ealth Products in Canada Web 2004/04/ /03 ealth Canada Canadian Adverse Reaction ewsletter ealth Canada, Regional Adverse Reaction Centres Dear ealth Professional Letters ealth Canada ealth Canada ealth Canada Decima Research Inc. 2 1, / 4
5 1 ealth Canada 2 ealth Canada ealth Canada Decima ealth Canada 2 1 ADRs 2 ADR ealth Canada ealth Canada ealth Canada ealth Canada, Canadian Adverse Reaction ewsletter Vol.14 o.2 April 2004 Web 2004/04/ Sterol and sterolin-containing products: hematologic adverse reactions Sterol sterolin ealth Canada sterol phytosterol sterol -sitosterol campesterol stigmasterol Sterolin sterol phytosterol sitosterol 5% phytosterol sitosterol sitosterol 63% 5
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7 6, % ood and Drugs Act and Regulations % % , , AR 2, , , , ealth Canada % , , , , * 1, , / 1, , , , easibility study of active surveillance of adverse reactions in children ealth Canada MPD Marketed ealth Products Directorate Children's and Women's ealth Centre of British Columbia Pharmaceutical utcomes Programme
8 CPSP Canadian Paediatric Surveillance Program CPSP 2, ealth Canada CPSP CPSP ealth Canada MPD 4 Public opinion survey on key issues pertaining to post-market surveillance of marketed health products in Canada 2003 ealth Canada Decima Research ealth Canada ealth Canada Dear ealth care Professionals Letters Public Advisories the Canadian Adverse Reaction ewsletter 8
9 5 Case presentation Clopidogrel Plavix : suspected association with hepatitis ealth Canada clopidogrel 2 84 clopidogrel 75mg/ aspirin Clopidogrel 8 clopidogrel 1 11 clopidogrel 76 1 Batwa, Lamoureux E, riedman G. Clopidogrel-induced liver injury. Can J Gastroenterol 2003;17 Suppl A :137. S Cl C 3 2 S 4 Clopidogrel Sulfate 2004/04/19 Z MEDSAE Prescriber Update Articles 1 Diarrhoea with Beta-Blockers - Blast from the Past 2004/04 Carvedilol
10 CARM Centre for Adverse Reactions Monitoring [ Dilatrend ] carvedilol carvedilol 1 Adverse Drug Reactions Unit 11 carvedilol 1 10% C Carvedilol 2 Visual Disturbances with CX-2 Inhibitors 2004/03 celecoxib rofecoxib CX-2 SAIA CX-2 SAIA Dunedin Pharmacovigilance Centre celecoxib rofecoxib celecoxib rofecoxib 2 1 CX CX-2 W 10
11 celecoxib rofecoxib celecoxib 1 4 ibuprofen 2 SAIA Celebrex celecoxib Vioxx rofecoxib 78 rofecoxib 50mg 25mg 2 6/18 Rofecoxib 81 celecoxib 100mg Celecoxib Celecoxib 8 CX-2 SAIA 2 1 indomethacin Celecoxib rofecoxib CX-1 CX-2 CX-2 SAIA CX celecoxib rofecoxib W CX-2 SAIA SAIA 11
12 C 3 S 2 Celecoxib CX /04/19 S C3 Rofecoxib CX-2 Phase III 2004/04/20 3 Inhaled Corticosteroids - Watch for Skin Atrophy 2004/03 400mcg/ n=9 1,600 mcg/ n=10 budesonide mcg/ budesonide 27 1,500 mcg/ fluticasone propionate 750mcg/ beclomethasone budesonide fluticasone CARM 12
13 UVB UVA tretinoin S 3 C C 3 3 C C 3 luticasone Propionate 3 C 3 C * C 3 3 C Cl 3 C C 3 C 3 C 3 Beclomethasone Dipropionate C Budesonide 4 Re: The use of SSRI antidepressants in children and adolescents 2004/03/22 MARC Medicines Adverse Reaction Committee 18 MDD SSRI MARC MDD SSRI SSRI 13
14 MARC 18 MDD SSRI MDD MDD SSRI Medsafe MARC CSM American College of europsychopharmacology DA advisory committees Royal Australian and ew Zealand College of Psychiatrists MDD CSM DA luoxetine citalopram paroxetine sertraline venlafaxine citalopram paroxetine sertraline venlafaxine / CMS fluoxetine SSRI DA MARC MDD SSRI DA MARC ew Zealand prescribing information MARC SSRI 18 MDD MARC SSRI C 3 Cl C C 3 C 3 Br luoxetine ydrochloride SSRI Phase III 2004/04/19 Citalopram ydrobromide SSRI Phase II 1996/ /03/11 14
15 C 3 Cl Paroxetine ydrochloride SSRI Cl Cl Cl Sertraline ydrochloride SSRI 2004/04/19 3 C C 3 C3 Cl Venlafaxine ydrochloride SRI Phase III 2004/04/20 EU EMEA 15
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Vol.2 o.10 (2004/05/27) MRA.1 [ Desyrel ] trazodone hydrochloride FDA.2 [ Zelnorm ] tegaserod hydrogen maleate ealth Canada.3 ealth Canada.5 [ Viread ] tenofovir disoproxil fumarate ealth Canada.5 [ rthoclone
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Vol.1 o.27 (2003. 10. 10) [ Reductil ] sibutramine MRA.1 [ Celance ] pergolide MRA.2 SAIDs MRA.3 MRA.3 [ Prandin ] repaglinide FDA.4 FD&C Blue o.1 FDA.5 [BDDrFVIII] [ ReFacto ] moroctocog- ealth Canada.6
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Vol.2 No.12 (2004/06/24) I [ Crestor ] rosuvastatin 40mg MHRA.2 domperidone FDA FDA.2 [ Crestor ] rosuvastatin FDA FDA.3 2004 6 9 FDA.4 Health Canada SSRI Health Canada.5 SSRI Health Canada.6 Australian
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Vol.3 No.3 2005/02/10 Co-proxamol paracetamol/dextropropoxyphene MHRA.1 2005 1 28 FDA.3 FDA/CDER 2004 11 FDA.3 MCI[ Reminyl ] galantamine Health Canada.5 [ Lariam ] mefloquine Health Canada.5 [ Humira
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Vol.3 No.8 2005/04/28 [ Bextra ] valdecoxib MHRA.1 FDA COX-2 NSAID FDA.2 FDA NSAID FDA.6 FDA.7 2005 [ Trileptal ] oxcarbazepine FDA.8 FDA/CDER 2005 2 FDA.9 gefitinib NIH.11 Health Canada [ Bextra ] valdecoxib
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FDA-MEDWatch Program Visit Department of Clinical Pharmacology, Division of Information Medicine, Medical Research Institute, Tokyo Medical and Dental University 2-3-10 Kanda-surugadai, Chiyoda-ku, Tokyo
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