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1 Vol.1 o.20 ( ) RT Million Women Study MRA.1 pyrazinamide rifampin FDA.4 FDA/CDER FDA.4 Salmeterol FDA.9 ADEC TGA.10 MRA ormone replacement therapy RTand breast cancer results of the UK Million Women Study Million Women Study LancetRT CSMthe Committee on Safety of Medicines RTEWGexpert working group Estrogenconjugated estrogensestradiol RTestrogen+progestogenmedroxyprogesterone acetatenorethisteronenorgestrel/ levonorgestrelestrogen [ Livial ]tibolonert RT12 RT5RT RT RT RT11 RT Tibolone 1

2 Million Women Study RT 50 CSMRTEWGRTRT RT20027WIWomen s ealth Initiative Million Women StudyLancet RTtiboloneestrogenprogestogenandrogen RTWI JAMA RT5RT RTEstrogen RTRR = 2.00RTestrogen RR = 1.30tiboloneRR = 1.45 estrogenrt RT510Million Women Study WI 651,000 RT50 *1 2 estrogen estrogen-progestogen RT50651, RT50641,0005 3RT 2

3 estrogen RT RT 1Risks and benefits of estrogen plus progestin in healthy postmenopausal women. JAMA 2002; 288: Breast cancer and hormone replacement therapy in the Million Women Study. Lancet 2003;362: Pub Medabstract Abstract C 3 C 3 a 3 S a 3 S a 3 S Conjugated EstrogensConjugated estrogensbp 3 C 3 C Estradiol Medroxyprogesterone Acetate 3 C C 3 C C orethisteroneorgestrel 3

4 C LevonorgestrelTibolone FDA Pyrazinamide plus Rifampin for Treatment of Latent Tuberculosis Infection (LTBI) CDC pyrazinamide rifampin 2 FDA CDC Vol.1 o.19 2 C3 C3 3C C3 C3 C3 3C C3 C3 C3 Pyrazinamide RifampicinJPRifampinUSP 2.Summary View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)April 2003web

5 CCTRAIDICATISBWBXED WARIG WWARIGSPPRECAUTISARADVERSE REACTIS C BW W P AR Epirubicin ydrochloride* Ellence Injection Lepirudin (rda) Refludan for Injection Acitretin Soriatane Capsules Bexarotene Targretin Capsules Flucytosine* Ancobon Capsules Amiodarone ydrochloride* Cordarone Tablets albuphine ydrochloride ubain Injection Sirolimus Rapamune ral Solution and Tablets Metoclopramide* Reglan Tablets 3.3% Sorbitol Irrigation in Plastic Container 3.3% Sorbitol Irrigation in Plastic Container Lisinopril/ydrochlorothiazide* Zestoretic Tablets Simvastatin* Zocor Tablets Alclometasone Dipropionate Aclovate Cream and intment Melphalan ydrochloride Alkeran for Injection Branched Chain Amino Acid 4% BranchAmin Injection in Viaflex Plastic Prednisolone Acetate phthalmic Suspension Econopred and Econopred Plus Sulfadoxine and Pyrimethamine Fansidar Tablets Metronidazole Flagyl 375 Capsules Flagyl ER Extended Release Tablets Flagyl Tablets Dexamethasone phthalmic Suspension Maxidex Meloxicam Mobic Tablets ystatin Lozenges Mycostatin Pastilles Tobramycin Sulfate Injection ebcin Vials and yporets Tobramycin Sulfate for Injection ebcin Vials Malathion vide Lotion xandrolone xandrin Tablets lopatadine ydrochloride phthalmic Solution Patanol Potassium Chloride in 5% Dextrose and Sodium Viaflex Plus container Chloride Injection, USP Amino Acid 20% Pro-Sol-sulfite-free Injection in Viaflex plastic container Amino Acid RenAmin Injection Clobetasol Propionate Emollient Cream Temovate E Emollient Clobetasol Propionate Cream Temovate Cream and intment Clobetasol Propionate Temovate Scalp Application Topiramate Topamax Tablets and Sprinkle Capsules Brand of Iopromide Ultravist Injection Rimexolone phthalmic Suspension Vexol Piperacillin Sodium/Tazobactam Sodium Zosyn Cetirizine Cl 5 mg and Pseudoephedrine Cl Zyrtec-D 12 our Extended Release Tablets 120 mg Candesartan Cilexetil Atacand Tablets Clarithromycin Biaxin XL Filmtab Extended-Release Tablets Kit for the Preparation of Technetium Tc99m CardioTec Teboroxime Metronidazole oritate Cream 5

6 C BW W P AR Milrinone Lactate Primacor Injection Primacor in 5% Dextrose Injection Sparfloxacin Zagam Tablets Epirubicin ydrochloride Flucytosine Amiodarone ydrochloride [ Ellence ] 1,500cells/mm 3 anthracycline epirubicin anthracycline anthracenedione Epirubicin [ Cordarone ] X mg/m 2 25mg/kg 6

7 Metoclopramide Metoclopramide MS MS 2Syndrome malin CKCPK Lisinopril/ ydrochlorothiaz ide/ ACE / ACE C-1 CT ACE Lisinopril 1. ACE Simvastatin MG-CoA 80mg 80mg

8 3 C 2 Cl F 2 Epirubicin ydrochlorideflucytosine I I Cl Amiodarone ydrochloridemetoclopramide 2 C C LisinoprilACE ydrochlorothiazide Cl 2 2 S Cl S 3 C 3 C 3 C SimvastatinMG-CoA 8

9 3. Labeling Changes for Drug Products that Contain Salmeterol FDA CPD salmeterol [Serevent Inhalation Aerosol][Serevent Diskus] [Advair Diskus] salmeterol FDA Salmeterol[Serevent Inhalation Aerosol] SMARTSalmeterol Multi-center Asthma Research Trial FDA [Serevent] [Advair ] GlaxoSmithKline SMART ,000 [Serevent] 13,174 13, [Serevent] SMART [Serevent] [Serevent] FDA CPD salmeterol FDA salmeterol CPD CPD FDA salmeterol 9

10 C 2 Salmeterol Xinafoate 2 ealth Canada TGA ADEC statement on use of hormone replacement therapy ADECRT RT RT WIWomen's ealth Initiative 2 estrogen progestogen RT RT WI Million Women Study estrogen estrogen progestogen [Livial] tibolonert 1 RT RT RT RT estrogen/progestogen RT 5 10

11 progestogen estrogen ADEC 5 10 estrogen RT 1.5 /1,000 5/1,000 estrogen + progestogen RT 6/1,000 19/1, Lancet WI RT 3 4 RT WI RT 12 5 WI WI 1, , RT 1, Scarabin VTE WI VTE estrogen VTE RT RT 1 1 RT RT WI Million Women Study RT 11

12 1Million Women Study Collaborators. Lancet : Writing Group for the Womens ealth Initiative JAMA : Shumaker, S A, Legault, C et al. JAMA : Manson, J E, sia, P J et al. EJM : ays, J, ckene, J K et al. EJM : Scarabin, P-Y, ger, E et al. Lancet : EU EMEA 12

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Microsoft Word doc 医薬品安全性情報 Vol.1 o.19 (2003. 8. 15) 国立医薬品食品衛生研究所安全情報部目次各国規制機関情報 FDA/CDER による安全性に関する表示改訂の概要 (2003 年 3 月 ) 米 FDA p.1 更新: 潜伏結核感染の rifampin,pyrazinamide 併用療法に関する有害事象データおよび米国胸部学会 /CDC の勧告米 CDC p.3 ホルモン補充療法の専門家諮問グループ代表によるアドバイス