医薬品安全情報Vol.3 No.8 (2005/04/28)

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1 Vol.3 No /04/28 [ Bextra ] valdecoxib MHRA.1 FDA COX-2 NSAID FDA.2 FDA NSAID FDA.6 FDA [ Trileptal ] oxcarbazepine FDA.8 FDA/CDER FDA.9 gefitinib NIH.11 Health Canada [ Bextra ] valdecoxib [ Celebrex ] celecoxib Pfizer Health Canada.12 Canadian Adverse Reaction Newsletter Vol.15 No Health Canada Synvisc Hylan G-F 20 : Plavix clopidogrel : Lipitor atorvastatin cyclosporine.18 [ Bextra ] valdecoxib EMEA EU EMEA.19 [ ] 2005/04/20 MHRA 1. Press Release 2005/04/07 European suspension of [ Bextra ] [ Bextra ] valdecoxib EMEA COX-2 [ Bextra ] valdecoxib COX-2 1

2 CSM Committee on Safety of Medicines Gordon Duff [ Bextra ] [ Bextra ] COX-2 MHRA [ Bextra ] [ Bextra ] MHRA Kent Woods EMEA valdecoxib COX-2 Phase II/III 2005/04/ /04/07 FDA 1. FDA Public Health Advisory 2005/04/07 FDA Announces Important Changes and Additional Warnings for COX-2 Selective and Non-Selective Non-Steroidal Anti-Inflammatory Drugs NSAIDs FDA COX-2 NSAID FDA [ Bextra ] valdecoxib Pfizer Pfizer FDA [ Bextra ] FDA COX-2 NSAID Celebrex celecoxib NSAID Medication Guide Medication Guide FDA OTC NSAID Aspirin 2

3 FDA NSAID FDA FDA [ Bextra ] valdecoxib FDA [ Bextra ] Pfizer [ Bextra ] FDA CABG [ Bextra ] [ Bextra ] [ Bextra ] NSAID [ Bextra ] Pfizer [ Bextra ] [ Bextra ] Celebrex celecoxib FDA Celebrex FDA Celebrex Pfizer Celebrex NSAID celecoxib Celebrex Celebrex 3

4 Medication Guide NSAID Celebrex Medication Guide NSAID Naproxen Celebrex FDA Pfizer Celebrex NSAID NSAID OTC NSAID COX-2 NSAID NSAID NSAID NSAID FDA FDA NIH NSAID FDA OTC NSAID NSAID FDA NSAID Medication Guide Medication Guide Medication Guide NSAID 4

5 NSAID OTC NSAID OTC NSAID FDA FDA ibuprofen Motrin Advil IbuTab 200 Medipren Cap-Profen Tab-Profen Profen Ibuprohm naproxen Aleve ketoprofen Orudis Actron OTC OTC NSAID Aspirin NSAID aspirin aspirin FDA FDA FDA MedWatch FDA FDA

6 2. FDA News 2005/04/07 FDA Announces Series of Changes to the Class of Marketed Non-Steroidal Anti-Inflammatory Drugs NSAIDs FDA NSAID FDA COX-2 NSAID OTC FDA CDER Dr. Steven K. Galson FDA FDA Pfizer [ Bextra ] valdecoxib FDA Celebrex celecoxib Pfizer Pfizer FDA [ Bextra ] Pfizer Celebrex FDA FDA NSAID CV GI Celebrex NSAID CV GI Medication Guide FDA OTC NSAID CV GI FDA OTC NSAID NSAID NSAID CV Merck COX-2 NSAID Vioxx rofecoxib FDA Vioxx Merck FDA FDA Agency's Arthritis Drug Safety and Risk Management Advisory Committee FDA Public Health Advisory PHA 6

7 URL COX-2 Main Page Questions and Answers Public Health Advisory FDA Public Health Advisory 2005/04/11 Deaths with Antipsychotics in Elderly Patients with Behavioral Disturbances FDA [ Zyprexa ] olanzapine [ Abilify ] aripiprazole [ Risperdal ] risperidone [ Seroquel ] quetiapine , FDA [ Clozaril ] clozapine [ Geodon ] ziprasidone FDA Olanzapine fluoxetine [ Symbyax ] FDA 7

8 4. FDA MedWatch Web 2005/04/ /04/ Safety Alert [ Trileptal ] oxcarbazepine 2005 [ Trileptal ] oxcarbazepine Novartis Pharmaceuticals [ Trileptal ] oxcarbazepine [ Trileptal ] 4 16 [ Trileptal ] SJS TEN [ Trileptal ] SJS TEN [ Trileptal ] 19 [ Trileptal ] re-challenge [ Trileptal ] TEN SJS [ Trileptal ] [ Trileptal ] [ Trileptal ] [ Trileptal ] [ Trileptal ] 8

9 Carbamazepine Oxcarbazepine Na channel antagonist Phase II 2004/02 6. FDA MedWatch Web 2005/04/15 Summary View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research CDER February 2005 FDA/CDER [ Copegus ] ribavirin USP [ Copegus ] ribavirin [ Pegasys ] peginterferon alfa-2a CHC C Child Pugh 6 B C CHC HIV Child Pugh 6 Child Pugh Child Pugh 5 Child Pugh mg/dl g/dl Child-Pugh A 5 6 B 7 9 C C 9

10 2 [ Duragesic ] fentanyl transdermal system [ Duragesic ] fentanyl transdermal system [ Duragesic ] Schedule II fentanyl Fentanyl hydromorphone methadone morphine oxycodone oxymorphone Schedule II 3 [ Lotronex ] alosetron hydrochloride Alosetron fluvoxamine CYP1A2 fluvoxamine alosetron AUC 6 3 [ Lotronex ] alosetron 4 [ Malarone ] atovaquone proguanil hydrochloride [ Malarone ] atovaquone and proguanil hydrochloride [ Malarone ] atovaquone proguanil hydrochloride Atovaquone/proguanil 5 [ Serostim LQ ] somatropin rdna origin injection [ Serostim LQ ] somatropin 6 [ Celexa ] citalopram hydrobromide [ Cymbalta ] duloxetine hydrochloride [ Effexor ] venlafaxine hydrochloride [ Effexor XR ] venlafaxine hydrochloride [ Lexapro ] escitalopram oxalate [ Nardil ] phenelzine sulfate, USP [ Prozac ] fluoxetine hydrochloride [ Sarafem ] fluoxetine hydrochloride [ Sinequan ] doxepin HCl [ Symbyax ] olanzapine and fluoxetine HCl [ Zoloft ] sertraline hydrochloride FDA Public Health Advisory 10/15/04 - Suicidality in Children and Adolescents Being Treated With Antidepressant Medications 10

11 7 [ Viramune ] nevirapine [ Viramune ] nevirapine 18 6 [ Viramune ] mg NIH 1. NIH News 2005/04/18 Clinical Trial of Gefitinib for Advanced Lung Cancer Closes Early gefitinib NSCLC [ Iressa ] gefitinib gefitinib Maryland Bethesda National Institutes of Health National Cancer Institute NCI Michigan Ann Arbor Southwest Oncology Group SWOG Gefitinib Delaware Wilmington AstraZeneca Pharmaceuticals LP gefitinib NCI [ Iressa ] [ Iressa ] III S ASCO gefitinib gefitinib III NSCLC cisplatin etoposide docetaxel gefitinib gefitinib SWOG Ann Arbor Michigan Laurence Baker SWOG 11

12 2 gefitinib NCI Scott Saxman , ,510 29% 1 S0023 A Phase III Trial of Cisplatin/Etoposide/Radiotherapy with Consolidation Docetaxel Followed by Maintenance Therapy with ZD 1839 or Placebo in Patients with Inoperable Locally Advanced Stage III Non-Small Cell Lung Cancer. 2 Gandara DR, Chansky K, Albain KS, Leigh BR, Gaspar LE, Lara PN Jr, Burris H, Gumerlock P, Kuebler JP, Bearden JD, Crowley J, Livingston R. Consolidation docetaxel after concurrent chemoradiotherapy in stage IIIB non-small-cell lung cancer: phase II Southwest Oncology Group study S9504. J Clin Oncol : , gefitinib EGFR Health Canada 1. Advisory 2005/04/07 Health Canada has asked Pfizer to suspend sales of its drug [ Bextra ] and informs canadians of new restrictions on the use of [ Celebrex ] Health Canada [ Bextra ] valdecoxib [ Celebrex ] celecoxib Pfizer Health Canada Phizer [ Bextra ] valdecoxib [ Celebrex ] celecoxib Health Canada Phizer Canada [ Bextra ] valdecoxib Pfizer Health Canada / Health Canada Health Canada Health Canada

13 [ Bextra ] Health Canada [ Bextra ] [ Bextra ] Health Canada [ Bextra ] COX-2 [ Celebrex ] celecoxib [ Celebrex ] Health Canada COX-2 NSAID [ Celebrex ] [ Bextra ] COX-2 Health Canada 2004 Vioxx rofecoxib [ Celebrex ] COX-2 NSAID [ Celebrex ] 1 [ Celebrex ] Health Canada COX-2 NSAID Health Canada Health Canada [ Celebrex ] 13

14 COX-2 NSAID COX-2 NSAID [ Celebrex ] [ Celebrex ] [ Bextra ] [ Bextra ] COX-2 NSAID COX-2 NSAID Health Canada COX [ Bextra ] etoricoxib lumiracoxib parecoxib COX-2 celecoxib COX /04/11 2. Canadian Adverse Reaction Newsletter Vol.15 No /04/ Synvisc Hylan G-F 20 : reported incidents of joint inflammation and pain Synvisc Hylan G-F 20 : Synvisc Hylan G-F 20 hyaluronan sodium hyaluronate hyran 1 14

15 Health Canada Synvisc hyran Health Canada Hylan G-F 20 Health Canada 1 Synvisc Hylan G-F 20 [prescribing information] Ridgefield NJ : Genzyme Biosurgery. Revised 2004 Nov Goldberg VM, Coutts RD. Pseudoseptic reactions to hylan viscosupplementation: diagnosis and treatment. Clin Orthop 2004; 419 : Bernardeau C, Bucki B, Liote F. Acute arthritis after intra-articular hyaluronate injection: onset of effusions without crystal. Ann Rheum Dis 2001;60 5 : Hylan G-F /04/21 Hylan G-F 20 Hylan polymers (hylan A + hylan B) 16 mg, Sodium chloride 17 mg Disodium hydrogen phosphate 0.32 mg, Sodium dihydrogen phosphate monohydrate 0.08 mg Water for injection ml 2 Adverse reaction reporting Health Canada 10,238 Health Canada 15

16 7, % Food and Drug Act and Regulation % Health Canada 1 : Health Canada AR % , , AR 2, , , , : % , , , , , , / 1, , , ,

17 3 Products derived from bees: serious adverse reactions 1 Health Canada AR ,4 1, Natural Health Products Regulations Natural Product Number NPN 17

18 Drug Identification Number-Homeopathic Medicine DIN-HM 1 Jellin JM, Gregory PJ, Batz F, Hitchens K, et al. Pharmacist's Letter/Prescriber's Letter Natural Medicines Comprehensive Database. 6th ed. Stockton CA : Therapeutic Research Faculty; p , , Chivato T, Juan F, Montoro A, Laguna R. Anaphylaxis induced by the ingestion of a pollen compound. J Investig Allergol Clin Immunol 1996;6 3 : Greenberger P, Flais M. Bee pollen-induced anaphylactic reaction in an unknowingly sensitized subject. Ann Allergy Asthma Immunol 2001;86: Thien FCK, Leung R, Baldo BA, Weiner JA, Plomley R, Czarny D. Asthma and anaphylaxis induced by royal jelly. Clin Exp Allergy 1996;26 2 : Hausen BM, Wollenweber E, Senff H, Post B. Propolis allergy. I. Origin, properties, usage and literature review. Contact Dermatitis 1987;17 3 : Case Presentation Plavix clopidogrel : suspected drug interaction with Lipitor atorvastatin and cyclosporine resulting in rhabdomyolysis Plavix clopidogrel : Lipitor atorvastatin cyclosporine cyclosporine 65 mg 1 2 Lipitor 80 mg 1 1 Imuran prednisone lisinopril Apo-Allopurinol furosemide Plavix 75 mg 1 1 Plavix 3 94, U/L Cyclosporine Lipitor Plavix Apo-Allopurinol Cyclosporine 3 Lipitor 11 HMG-CoA cyclosporine 1,2 cyclosporine 18

19 Lipitor Plavix 2 cyclosporine HMG-CoA clopidogrel 2 1 Lipitor atorvastatin [product monograph]. Kirkland QC : Pfizer Canada Inc; Uber PA, Mehra MR, Park MH, Scott RL. Clopidogrel and rhabdomyolysis after heart transplantation [letter]. J Heart Lung Transplant 2003;22 1 : clopidogrel 2005/04/21 atorvastatin HMG-CoA TGA 2005/04/04 EU EMEA 1. European Medicines Agency statement on the suspension of use of [ Bextra ] 2005/04/07 [ Bextra ] valdecoxib EMEA EMEA Pfizer COX-2 [ Bextra ] valdecoxib Pfizer FDA EMEA COX COX-2 EMEA [ Bextra ] 2 COX-2 CABG CABG [ Bextra ] [ Bextra ] EMEA COX CHMP 1. [ Bextra ] valdecoxib COX-2 1 [ Bextra ] EU Pfizer [ Bextra ] 19

20 EMEA COX EMEA [ Bextra ] 20

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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