Health Canada...p.5....p.6 Australian Adverse Drug Reactions Bulletin Vol.24 No.4 TGA [ ]
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1 I NSAID MHRA...p.1 MHRA...p.2 NSAID EU EMEA...p.5 Health Canada...p.5 Paroxetine pimozide QT Health Canada...p.6 Australian Adverse Drug Reactions Bulletin Vol.24 No.4 TGA SSRI...p.7 Ezetimibe...p.9 Cabergoline...p.10 [ ] I 2005/08/03 Vol No.15 08/11 R8 MHRA News Review of the cardiovascular safety of non-steroidal anti-inflammatory drugs NSAIDs NSAID 2005/08/02 NSAID Committee on 1
2 Safety of Medicines CSM Vol No.15 08/11 R1 MHRA 1. Cardiovascular Safety of Non-Steroidal Anti-inflammatory Drugs: Overview of key data 2005/08/ EU NSAID NSAID ibuprofen diclofenac naproxen, meloxicam ketoprofen nimesulide etodolac nabumetone indometacin NSAID COX-2 TXA2 COX-2 NSAID COX-2/COX-1 3 NSAID COX-2/COX-1 diclofenac COX-2 ibuprofen naproxen COX-1 95% COX-1 naproxen COX-1 COX-2coxib ibuprofen aspirin Naproxen diclofenac COX-2 NSAID COX-2 COX-1 2
3 NSAID Naproxen diclofenac ibuprofen COX-2 1 naproxen COX-2 naproxen ADAPT naproxen 200mg1 2 naproxen COX-2 diclofenac ibuprofen 1 COX-2 coxib NSAID ibuprofen aspirin NSAID diclofenac ibuprofen naproxen NSAID COX-2 ibuprofen 2,400mg/ coxib 2 NSAID coxib 1 NSAID NSAID OTC 3
4 NSAID Naproxen Ibuprofen Diclofenac Aspirin ibuprofen ADR ADR coxib NSAID NSAID coxib NSAID naproxen ibuprofen diclofenac naproxen COX-2 COX-2 ibuprofen diclofenac naproxen NSAID NSAID NSAID NSAID aspirin ibuprofen Naproxen aspirin NSAID COX-2 4
5 NSAID NSAID 12 Letter to healthcare professionals and question and answers Vol No.15 08/11 R7 EU EMEA 1. EMEA Press Release on the cardiovascular safety of non-selective NSAIDs NSAID 2005/08/02 EMEA 6 CHMP NSAID 9 FDA Vol No.15 08/11 R2 Health Canada 1. Health Canada advises about vision problems possibly associated with [ Viagra ], [ Cialis ] and [ Levitra ] 2005/07/26 [ Viagra ] sildenafil [ Cialis ] tadalafil [ Levitra ] vardenafil NAION FDA Vol.3 No
6 sildenafil PDE5 cgmp-specific type 5 phosphodiesterase tadalafil PDE5 cgmp-specific type 5 phosphodiesterase 2005/07/27 vardenafil PDE5 cgmp-specific type 5 phosphodiesterase Vol No.15 08/11 R3 Health Canada Health Canada Endorsed Important Safety Information on Concomitant Use of [ Paxil ] or [ Paxil CR ] and [ Orap ] pimozide Paroxetine pimozide QT 2005/07/22 GlaxoSmithKline GSK Health Canada [ Paxil ] paroxetine hydrochloride [ Paxil CR ] paroxetine hydrochloride I paroxetine 60mg1 1 pimozide [ Paxil ][ Paxil CR ] Paroxetine pimozide [ Paxil ] pimozide Pimozide QT [ Paxil ] 1 60mg pimozide 2mg pimozide pimozide AUC 151% Cmax 62% Pimozide QT pimozide [ Paxil ] GSK [ Paxil ] [ Paxil CR ] Health Canada paroxetine SSRI 6
7 pimozide Vol No.15 08/11 R4 TGA 1. Australian Adverse Drug Reactions Bulletin Vol.24 No.4 Suicidality with SSRIs: adults and children SSRI 2005/08/ ADRAC SSRI SSRI 1 SSRI 18 ADRAC SSRI ADRAC SSRI SSRI 2,3 SSRI SSRI SSRI Jick SSRI fluoxetine paroxetine dothiepin 4 Jick SSRI Jick 5 SSRI
8 SSRI SSRI TGA SSRI SSRI citalopram escitalopram fluoxetine fluvoxamine paroxetine sertraline venlafaxine 1 ADRAC. Use of SSRI antidepressants in children and adolescents. Aust Adv Drug Reactions Bull 2004;23:22. 2 Healy D, Whitaker C. Antidepressants and suicide: risk-benefit conundrums. J Psychiatry Neurosci 2003;28: Breggin PR. Suicidality, violence and mania caused by selective serotonin reuptake inhibitors SSRIs : a review and analysis. Intern J Risk & Safety in Medicine 2003/2004;16: Jick H, Kaye JA, Jick SS. Antidepressants and the risk of suicidal behaviors. J Amer Med Assoc 2004;292: Fergusson D, Doucette S, Cranley Glass K, Shapiro S, Healy D et al. Association between suicide attempts and selective serotonin reuptake inhibitors: systematic review of randomised controlled trials. BMJ 2005;330: Hall WD, Mant A, Mitchell PB, Rendle VA, Hickie IB, McManus P. Association between antidepressant prescribing and suicide in Australia, : trend analysis. BMJ 2003;326:
9 Vol No.15 08/11 R5 TGA 1. Australian Adverse Drug Reactions Bulletin Vol.24 No.4 Ezetimibe and muscle disorders Ezetimibe 2005/08/03 [ Ezetrol ] ezetimibe ezetimibe ezetimibe 2% 2.4% ezetimibe 3.2% 1 atorvastatin fluvastatin pravastatin simvastatin 2 Ezetimibe ezetimibe 3 ADRAC ezetimibe ezetimibe ezetimibe 3 4 ezetimibe 1 ezetimibe atorvastatin 80 mg/ ADRAC ezetimibe 1 Ezetrol, Australian Product Information, Merck Sharp & Dohme Aust. Pty Ltd. 2 Jun ADRAC. Risk factors for myopathy and rhabdomyolysis with the statins. Aust Adv Drug Reactions Bull 2004;23:2. 3 Association of Ezetrol ezetimibe with myalgia, rhabdomyolysis, hepatitis, pancreatitis, and 9
10 thrombocytopenia. Public Advisory Health Canada and Merck Frosst/Schering Pharmaceuticals, 1 Feb Internet: accessed 23 Jun Fux R, Morike K, Gundel U-F, Hartmann R, Gleiter CH. Ezetimibe and statin-associated myopathy. Ann Intern Med 2004;140: ezetimibe 2005/06/29 Vol No.15 08/11 R6 TGA 1. Australian Adverse Drug Reactions Bulletin Vol.24 No.4 Pathological gambling with cabergoline Cabergoline 2005/08/03 ADRAC 2 [ Cabaser ] cabergoline 4 ADRAC 4 4 levodopa cabergoline 4 3 cabergoline 1 levodopa pergolide pramipexole levodopa levodopa 1 Driver-Dunckley E, Samanta J, Stacy M. Pathological gambling associated with dopamine agonist therapy in Parkinson's disease. Neurology 2003; 61: 42,, 10
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