Drug Safety Newsletter 2006.June. Vol.14 酶 Taiwan Drug Relief Foundation National Reporting Center of Adverse Drug Reactions in Taiwan
by 1. NovoSeven 2005 12 05 ADR 2005 11 NovoSeven NovoSeven (Disseminated Intravascular Coagulation, DIC) NovoSeven NovoSeven / NovoSeven D-dimer 2. Epogen Procrit epoetin alfa Aranesp darbepoetin alfa 2005 12 12 ADR Ortho Biotech Amgen Epogen Procrit epoetin alfa Aranesp darbepoetin alfa 2005 11 Epogen Procrit Aranesp pure red cell aplasia anti--erythropoietin antibody-associated anemia 2 Drug Safety Newsletter 2006 June. Vol.14
CRF SC IV erythropoietin neutralizing antibodies to erythropoietin http://www.fda.gov/medwatch/safety/2005/safety05.htm#epoetin http://www.fda.gov/medwatch/safety/2005/safety05.htm#aranesp2 3. Paroxetine 2005 12 16 ADR FDA 2005 12 paroxetine paroxetine paroxetine C D paroxetine paroxetine paroxetine paroxetine paroxetine (Swedish national registry data) paroxetine 2 vs. 1 paroxetine 1.5 (1.5% vs. 1%) paroxetine 2 (4% vs. 2%) http://www.fda.gov/medwatch/safety/2005/safety05.htm#paxil3 Drug Safety Newsletter 2006 June. Vol.14 3
4. Avandia (rosiglitazone) 2006 01 09 ADR Avandia (rosiglitazone) Avandia (diabetic macular edema) http://www.fda.gov/medwatch/safety/2006/safety06.htm#avandia 5. WinRho SDF Rho D Immune Globulin Intravenous Human 2006 01 18 ADR Cangene Baxter Healthcare WinRho SDF Rho D Immune Globulin Intravenous Human 1 WinRho SDF ITP WinRho SDF ITP WinRho SDF / 2 WinRho SDF glucose-specific glucose dehydrogenase pyroroloquinolonequinone GDH-PQQ glucose-dye-oxidoreductase WinRho SDF glucose-specific http://www.fda.gov/medwatch/safety/2006/safety06.htm#winrho 4 Drug Safety Newsletter 2006 June. Vol.14
6. Elidel (pimecrolimus) Protopic (tacrolimus) 2006 01 20 ADR FDA Elidel (pimecrolimus) Protopic (tacrolimus) (eczema) (atopic dermatitis) 10-15 http://www.fda.gov/bbs/topics/news/2006/new01299.html 7. 2006 01 24 ADR Annals of Internal Medicine 2006 01 20 Ketek (telithromycin) FDA MedWatch Telithromycin FDA FDA telithromycin telithromycin Drug Safety Newsletter 2006 June. Vol.14 5
telithromycin FDA http://www.fda.gov/medwatch/safety/2006/safety06.htm#ketek 8. Clozaril clozapine 2006 01 26 ADR Novartis Clozaril clozapine 1 Psychopharmacological Drugs Advisory Committee 2003 6 Clozaril clozapine clozapine WBC ANC clozapine 3500/mm 3 ANC 2000/mm 3 WBC ANC 3500/mm 3 ANC 2000/mm 3 clozapine 3000/mm 3 >WBC 2000/mm 3 / 1500/mm 3 >ANC 1000/mm 3 clozapine clozapine 2 Clozaril clozapine dementia-related psychosis aripiprazole olanzapine risperidone quetiapine 17 1.6-1.7 6 Drug Safety Newsletter 2006 June. Vol.14
FDA clozapine 3 Clozaril clozapine paralytic ileus clozapine hypercholesterolemia hypertriglyceridemia 4 citalopram clozapine http://www.fda.gov/medwatch/safety/2006/safety06.htm#clozaril 1. Gambro Prisma 2006 03 13 ADR Prisma fluid overload 5000 1900 CRRT 9 11 2005 8 16 Gambro Prisma FDA Prisma Prisma CRRT FDA Drug Safety Newsletter 2006 June. Vol.14 7
1 access pressure pod 2 i. ii. iii. iv. unload v. vi. 3 ADR http://adr.doh.gov.tw/adr-med/mainnews-1.asp?id=74&title=&table=latestnews&dsn=&sub =2&Continue=Y&query http://www.fda.gov/cdrh/safety/022706-gambro.html 2006 03 29 ADR FDA 691 413 120 158 FDA! FDA " Hospital Bed System Dimensional and Assessment Guidance to Reduce Entrapment ref " 8 Drug Safety Newsletter 2006 June. Vol.14
! http://www.fda.gov/cdrh/beds/ 3. 2006 04 11 ADR FDA 109 30 28 28 26 FDA 3 1 2 3 1 2 3 4 3 6 5 ADR http://www.fda.gov/cdrh/safety/041006-keratitis.html Drug Safety Newsletter 2006 June. Vol.14 9
1. Bard Composix Kugel Mesh X-Large Patch 2006 03 07 ADR Composix Kugel Mesh Patch Composix Kugel Mesh Patch "memory recoil ring" 41XMXXX-M = 2002 41XNXXXX N = 2003 43XMXXXX M = 2002 43XOXXX-N = 2003 43XOXXXX-0=2004 43XOPXXX-P = 2005 ( M N O P ) 1. Composix Kugel Mesh Patch 2. Bard Composix Kugel Mesh Patch (1) 16 8 8 (2) Composix Kugel Mesh Patch http://www.fda.gov/cdrh/recalls/recall-122205.html FDA Total Knee 2006 04 04 ADR Ossur 2006 3 29 Total Knee 1100, 1900, 2000 2100 Total Knee Ossur Total Knee FDA ADR http://www.fda.gov/oc/po/firmrecalls/ossur03_06.html 02-2396-0100 www.adr.doh.gov.tw 10 Drug Safety Newsletter 2006 June. Vol.14
thioridazine 1 HCl 1969 2 2005 6 schizophrenia Novartis QTc QTc prolongation 36 40 cardiac arrhythmias sudden death phenothiazine Novartis Thioridazine Melleril 2005 6 30 1,2 Novartis 2004 12 benefit/risk assessment WHO, Uppsala Center for International Drug Safety Drug Safety Newsletter 2006 June. Vol.14 11
Monitoring Pharmaceutical Newsletter 3 2006 6 30 Pharmaceutical 4 2006 6 Newsletter Novartis thioridazine thioridazine / thioridazine 2005 QTc 1993 87 2004 QTc 1.3~8.9/100,000 1 thioridazine thioridazine 1 30 2005 QTc 6 17 2005 6 QTc 2005 6 2 2 5 12 Drug Safety Newsletter 2006 June. Vol.14
2006 6 FDA 2003 Thioridazine QTc Medicines and Healthcare Products Regulatory Agency, MHRA 2005 thioridazine 2006 5 List 7 A, May 2006 thioridazine MHRA thioridazine Committee on Safety of Medicines, CSM Administration, TGA Adverse Drug Reactions Advisory Committee, 6 ADRAC thioridazine QTc 540 thioridazine thioridazine cases including 6 medicines P.D.R. Physician Desk Reference 2005 1972 11 thioridazine National Drug Code Dictionary thioridazine 2004 2006 Therapeutic Goods 570 1140 Drug Safety Newsletter 2006 June. Vol.14 13
200 35 TGA 600 8 thioridazine thioridazine 2001 Special access 1396 Program thioridazine 373 2005 9 8 2005 9 30 26% 1% 9 New Zealand Pharmacovigilance Center thioridazine thioridazine 11 10 Health Canada thioridazine Novartis 2005 Thioridazine thioridazine QTc thioridazine QTc QTc 500 200 14 Drug Safety Newsletter 2006 June. Vol.14
torsades de pointes QTc Thioridazine P450 2D6 酶 QTc 酶 QTc thioridazine 500 Phenothiazine thioridazine thioridazine thioridazine 12,13,14 200 13 thioridazine thioridazine 31 7 QTc Drug Safety Newsletter 2006 June. Vol.14 15
QTc thioridazine 2 2005 6 97 6 30 Thioridazine thioridazine 02-2396-0100 http://adr.doh.gov.tw 16 Drug Safety Newsletter 2006 June. Vol.14
1. Weiden P. J. et al.. Switching antipsychotic medications. J Clin Psychiatry 1997; 58 (suppl 10): 63-72. 2. Voruganti et al.. Switching from conventional to novel antipsychotic drugs: results of a prospective naturalistic study. Schizophr Res 2002; 57: 201-208 3. THIORIDAZINE withdrawn due to poor benefit/risk profile, WHO Pharmaceutical Newsletter 2005; No. 1. 4. 94 6 17 0940 321413 available from: www.doh.gov.tw/ / 5. 95 7 13 0950328747 available from: www.doh.gov.tw/ / 6. Available from: http://www.mhra.gov.uk/home/idcplg?idc Service=SS_GET_PAGE&nodeId=301 7. Available from: 923s49lbl.pdf 8. Available from:http://www.tga.gov.au/adr 9. 2006: 1277-79. 10. Available from: http://www.medsafe.gov.nz/profs/adverse/ minutes120.htm 11. Available from: http://www.hc-sc.gc.ca/dhp-mps/medeff/a dvisories-avis/prof/2005/thioridazine_hpccps_e.html 12. Sean Hennessy et al.. Cardiac arrest and ventricular arrhythmia in patients taking antipsychotic drugs: cohort study using administrative data. BMJ 2002. 325. 13. Claudia Stöllbergrer et al.. Antipsychotic Drugs and QT prolongation. Acta Psychiatr Scand 2005; 111: 171-176. 14. Justo D. et al.. Torsade De points induced by psychotropic drugs and the prevalence of its risk factors. International clinical Psychopharmacology 2005; 20: 243-251. http://www.fda.gov/cder/foi/label/2001/17 Drug Safety Newsletter 2006 June. Vol.14 17
HMG-CoA 酶 1,2 1 1 2 3 1 2 3 HMG-CoA(3-hydroxy-3-methylgl (retrospective) utaryl coenzyme A) 酶 HMG-CoA 酶 2003 HMG-CoA 酶 (statins) HMG-CoA 酶 ( (rhabdomyolysis) ) (The Food and Drug Administration) Alanine aminotransferase (ALT) HMG-CoA 酶 Aspartate aminotransferase (AST) ALT AST HMG-CoA 酶 (baseline liver function test) HMG-CoA 酶 18 Drug Safety Newsletter 2006 June. Vol.14
(follow-up liver function test) 26.6% 2003 2004 HMG-CoA 酶 ( 3 ) 950 13 538 412 7 58.6±11.9 1 450 177 18.6 47.4% 722 atorvastatin 321 44.4 酶 228 31.58 520 fluvastatin 129 17.86 950 ( 3) HMG-CoA 酶 430 59.56 HMG-CoA 45.3% 2 22 31.8 430 45.3 HMG-CoA 17 3.3 酶 52.6% statin HMG-CoA 酶 statin 45.3% 253 atorvastatin 5 HMG-CoA 酶 Drug Safety Newsletter 2006 June. Vol.14 19
1. Gender N % Male 538 56.6 3.3% statin Female 412 43.4 Age yr 50 198 20.8 50 to 60 306 32.2 60 to 70 271 28.5 70 175 18.5 Average 58.6 11.9 3 45.3 27% statin 9% 1.8 4-5 Baseline liver 4 function test HMG-CoA 酶 Yes 450 47? No 500 53 HMG-CoA 酶 1.0 statins 50% HMG-CoA 酶 statin HMG-CoA 酶 statin HMG-CoA 酶 (24.6%) 950 HMG-CoA 酶 Maria 26.6% 5 clinical diagnostic scale (CDS) 20 Drug Safety Newsletter 2006 June. Vol.14
. Statin Baseline liver function test Yes No Number of follow-up test(s) <3 months (N=43) N (%) 3 to < 6 months (N=111) N (%) 6 to <12 months (N=460) N (%) 12 to 24 months (N=336) N (%) Total (N=950) N (%) 0 12 (27.9) 31 (27.9) 99 (21.5) 35 (10.4) 177 (18.6) 1 2 (4.7) 16 (14.4) 75 (16.3) 36 (10.7) 129 (13.6) 2 1 (2.3) 5 (4.5) 50 (10.9) 29 (8.6) 85 (8.9) 3 0 (0) 4 (3.6) 34 (7.4) 21 (6.3) 59 (6.2) 0 22 (51.2) 36 (32.4) 108 (23.5) 87 (25.9) 253 (26.6) 1 6 (14.0) 15 (13.5) 54 (11.7) 59 (17.6) 134 (14.1) 2 0 (0) 4 (3.6) 25 (5.4) 30 (8.9) 59 (6.2) 3 0 (0) 0 (0) 15 (3.3) 39 (11.6) 54 (5.7). Statin Follow-up test N(%) Baseline Test Abnormal Normal No data Abnormal 2 (0.2) 13 (1.4) 7 (0.7) Yes (N=22) Normal 6 (0.6) 252 (26.5) 170 (17.9) (N=428) No (N=500) 9 (0.9) 238 (25.1) 253 (26.6) Total (N=950) 17 (1.8) 503 (52.9) 430 (45.3) Drug Safety Newsletter 2006 June. Vol.14 21
1. 2003 2.Charles FL, Lora LA, Morton PG, et al. CDS Drug information handbook. Lexi-Comp Inc.13th edtion. 3.Susan EA, James GD, K. Arnold C, et al. Liver function testing in patients on HMG-CoA reductase inhibitorsy Pharmacoepidemiology and drug safety HMG-CoA 酶 2003; 12: 307 313 4.Christopher CS, Lana IB, Roger BD, et al. Screening for statin-realted toxicity. Archive of internal medicine.2003; 163:688-692 5.Maria VA, Victorino RM. Development and Validation of a Clinical Scale for the Diagnosis of Drug-Induced Hepatitis. Hepatology 1997;26:664-669 HMG-CoA 酶 54.7% 520 3.3% 22 Drug Safety Newsletter 2006 June. Vol.14
1 2 3 1 2 3 91 6 94 1 Drug Safety Newsletter 2006 June. Vol.14 23
3 2. 1 1. 1 2 i. 2 ii. iii. 24 Drug Safety Newsletter 2006 June. Vol.14
2. 3 2005 12 (1.) 1. (2.) (3.) / 2. (4.) (5.) SAE (certain) (probable/likely) 1. (possible) (unlikely) (unrelated) Drug Safety Newsletter 2006 June. Vol.14 25
Single Cases of Serious, Unexpected ADRs; SUADRs 93 10 26 0930333419 SAE 1. SAE 2. 3. SAE ICH E2A SUSARs (SAE), 26 Drug Safety Newsletter 2006 June. Vol.14
(1) (2) (3) (4) (5) (6) Drug Safety Newsletter 2006 June. Vol.14 27
SUSARs : 1. 91 6 2. 94 1 3. ICH Harmonized Tripartite Guideline E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting, 1994. 32 2 02 2358-7343 02 2396-0100 02 2358-4100 http://www.tdrf.org.tw http://adr.doh.gov.tw 2281 28 Drug Safety Newsletter 2006 June. Vol.14