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1 Vol.1 o.27 ( ) [ 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 Rofecoxib, celecoxib TGA.7 Mirtazapine TGA.8 TGA.9 TGA.10 MRA Current Problems in Pharmacovigilance Vol.29, September [ Reductil ] sibutramine :hypertension and tachycardia [ Reductil ] sibutramine BMI 30kg/m 2 2 BMI 27kg/m 2 13 sibutramine Yellow Card sibutramine

2 10bpm / 10mmg Cl C3 Cl 2 Sibutramine ydrochloride Phase II 2003/04/09 2 [ Celance ] pergolide and cardiac valvulopathy [ Celance ] pergolide levodopa Pergolide 1989 pergolide Mayo clinic 1 pergolide ergotamine Ergotamine ergotamine serotonin S S 3 Pergolide Mesilate D 1 D 2 2

3 3 Reminder:Gastrointestinal toxicity of SAIDs Ibuprofen CX-2 SAIDs aspirin SAIDs ibuprofen CX-2 CSM SAIDs SAIDs Aspirin SAIDs aspirin SAIDs Ibuprofen SAIDs CX-2 SAIDs SAIDs 4 Dopaminergic drugs and sudden sleep onset [ Mirapexin ] pramipexole 1999 levodopa carbidopa/benserazide dihydroergocryptine piripedil bromocriptine pergolide cabergoline pramipexiole ripinirole apomorphine lisuride quinagolide 3

4 S 2 2Cl 2 Pramipexole ydrochloride D 2 D /09/30 FDA 1. MedWatch 2003 Safety Alerts otice : [ Prandin ] repaglinide tablets Package Insert update [ Prandin ] repaglinide [ Lopid ] gemfibrozil iemi [ Prandin ] gemfibrozil repaglinide Gemfibrozi [ Prandin ] itraconazole [ Prandin ] itraconazole [ Prandin ] gemfibrozil Repaglinide gemfibrozil itraconazole P-450 repaglinide ovo ordisk 2 [ Prandin ] Gemfibrozil itraconazole gemfibrozil 600 mg [ Prandin ] 0.25mg/ 600 mg gemfibrozil repaglinide AUC 8.1 repaglinide Itraconazole [ Prandin ] 0.25mg/ itraconazole 200 mg 100 mg repaglinide AUC 1.4 [ Prandin ] gemfibrozi itraconazole repaglinide AUC 19 repaglinide repaglinide gemfibrozil 28.6 gemfibrozil-itraconazole 70.4 [ Prandin ] gemfibrozil in vivo repaglinide [ Prandin ] gemfibrozil gemfibrozil [ Prandin ] repaglinide [ Prandin ] gemfibrozil 4

5 [ Prandin ] [ Prandin ] gemfibrozil Gemfibrozil itraconazole [ Prandin ] [ Prandin ] gemfibrozil itraconazole Vol.1 o.8 p.2 Vol.1 o C 2 C 2 Repaglinide Gemfibrozil 2003/08/ /12/16 2. FDA Public ealth Advisory Subject: Reports of blue discoloration and Death in patients receiving enteral feedings tinted with the dye, FD&C Blue o. 1 FDA FD & C Blue o / FDA FDA FD&C 1 1 ADI 12.5 mg/kg/ FDA 26 ASPE2002 Jim Maloney, MD 5

6 ealth Canada Important safety information about [ ReFacto ] moroctocog- Antihemophilic Factor Recombinant [BDDrFVIII] VIII [ ReFacto ] [ ReFacto ] [B-domain-deleted recombinant factor VIII BDDrFVIII] 2002 A VIII [ ReFacto ] Wyeth Canada ,800 1,000 [ ReFacto ] VIII [ ReFacto ] VIII VIII [ ReFacto ] [ ReFacto ] Moroctocog- A VIII 6

7 TGA Australian Adverse Drug Reactions Bulletin Vol. 22, o. 5, Rofecoxib, celecoxib and cardiovascular risk rofecoxib VIGR rofecoxib naproxen 0.4% 0.1% 1 aproxen aspirin rofecoxib 2 VIGR 2 rofecoxib 50mg/ mg/ aspirin 2 retrospective analysis aspirin VIGR 4% 1 37% 4% 3 rofecoxib 4 rofecoxib > 25mg/ SAIDs 1.93 CD 95% ; P=0.024 celecoxib SAIDs rofecoxib CD naproxen rofecoxib Celecoxib 2 3 ADRAC Rofecoxib celecoxib celecoxib rofecoxib Rofecoxib 25 mg/ coxib celecoxib rofecoxib aspirin 3 aspirin coxib 1 Bombardier C, Laine L, Reicin A et al. Comparison of upper gastrointestinal toxicity of rofecoxib and naproxen in patients with rheumatoid arthritis. Engl J Med 2000;343: Mukherjee D, issen SE, Topol EJ. Risk of cardiovascular events associated with selective CX-2 inhibitors. JAMA 2001;286:

8 3 owes LG, Krum. Selective cyclo-oxygenase-2 inhibitors and myocardial infarction. ow strong is the link? Drug Safety 2002;25: Ray WA, Stein CM, Daugherty JR et al. CX-2 selective non-steroidal anti-inflammatory drugs and risk of serious coronary heart disease. Lancet 2002;360: S C3 S 2 F F F (Rofecoxib Celecoxib CX-2 CX-2 Phase III 2002/10/ /09/05 2 Convulsions and blood dyscrasias with mirtazapine [ Remeron, Avanza, Mirtazon ] mirtazapine ,000 ADRAC mirtazapine 253 PEM prescription event monitoring / / 1 5.8% 2.8% 1 ADRAC Mirtazapine mirtazapine PEM / 24 / /

9 9 mirtazapine PEM 2 mitazapine 1 Biswas P. Wilton LV, Shakir SAW. The pharmacovigilance of mirtazapine: results of a prescription event monitoring study on patients in England. J Psychopharmacology 2003;17: Mitazapine 2 Phase III 2003/08/06 3 Anti-epileptic drugs, pregnancy and fetal malformations AEDs anti-epileptic drugs 1 ADRAC AEDs FMs fetal malformations AEDs Pregnancy Registers Pregnancy Register 40 2 AEDs % 6.5% AEDs 2.4% 3 valproate 16.0% P<0.01 valproate 1 1,975mg 1,128mg, P< valproate 4.1; 95% CI AEDs 3 carbamazepine 2.5; oxcarbazepine 10.6;

10 5.8; AEDs 3.8% 0.8% P=0.02 AEDs 3 AEDs 1 ADEC. Anticonvulsants/antiepileptics. In Prescribing Medicines in Pregnancy. 4th Edn. 1999: Vajda F, 'Brien T, itchcock, Graham J, Cook M, Lander C, Eadie M. Critical Relationship between sodium valproate dose and human teratogenicity. Abstract presented at the meeting of the Australian Association of eurologists, May Kaaja E, Kaaja R, iilesmaa V. Major malformations in offspring of women with epilepsy. eurology 2003, 50:575-9 C 2 a 2 Sodium Valproate Carbamazepine GABA aminotransferase inhibitor 2 xcarbazepine a channel antagonist Phase II 2002/06/10 4 ormone replacement therapy TGA RT RT WI Women's ealth Initiative Million Women RT 10

11 EU EMEA 11

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untitled Vol.2 o.8 (2004/04/22) 2004 [ Clozaril ] clozapine DA.1 2004 [ Abilify ] aripiprazole DA.3 ealth Canada.4 Canadian Adverse Reaction ewsletter Vol.14 o.2 April 2004 ealth Canada Sterol sterolin.5 2003.6.7.8