医薬品安全性情報 Vol.6 No.26 2008/12/25 - nihs.go.jp

1 1 MHRA Medicines and Healthcare products Regulatory Agency Etoricoxib Arcoxia . 2 FDA U. S. Food and Drug Administration 2007 10 1 .. 3 Epoetin alfa Procrit / Epogen darbepoetin alfa Aranesp Medication Guide Q&A .. 5 Health Canada Alemtuzumab MabCampath B 6 .. 7 EU EMEA European Medicines Agency Rimonabant Acomplia EMEA .. 9 1 2 MedDRA-J 2008/12/25 2008/12/25 2 2008 12/25 R01 MHRA Etoricoxib Arcoxia Direct healthcare professional communication on in patients treated with Arcoxia etoricoxib Information sent to healthcare professionals in October 2008 about the safety of medicines 2008/10/02 Web 2008/10/31 Merck Sharp & Dohme Etoricoxib etoricoxib *1 EMEA etoricoxib Arcoxia 90mg *2 General Practice Research Database

2 150 mmHg / 90 mmHg etoricoxib Etoricoxib 140/90 mmHg Etoricoxib 2 SPC *3 1 2008 6 26 EMEA URL 2008/12/25 3 2 Etoricoxib Arcoxia SPC 3 SPC 2008 10 23 Etoricoxib COX-2 2008 12/25 R02 FDA 2007 10 1 Update of safety review follow-up to the October 1, 2007 early communication about the ongoing safety review of bisphosphonates.

3 Alendronate Fosamax , Fosamax Plus D , etidronate Didronel , ibandronate Boniva , pamidronate Aredia , risedronate Actonel , Actonel W/Calcium , tiludronate Skelid , and zoledronic acid Reclast , Zometa Early Communication 2008/11/12 #bisphosphonates2 FDA 2007 10 1 *1 New England Journal of Medicine 2007 5 3 correspondence letter to the editor zoledronic acid Reclast alendronate Fosamax 65 89 2 FDA Reclast Reclast FDA 2008/12/25 4 FDA 2007 10 1 alendronate ibandronate risedronate zoledronic

4 Acid 4 19,687 18,358 6 3 2 1,000 0 3 Zoledronic acid 1 / FDA FDA FDA FDA alendronate Fosamax Fosamax Plus D etidronate Didronel ibandronate Boniva pamidronate Aredia risedronate Actonel Actonel W/Calcium tiludronate Skelid zoledronic acid Reclast Zometa 7

5 1 2007/10/18 FDA Alendronic acid Alendronate Sodium Hydrate JAN Alendronate Sodium USAN Etidronic Acid Etidronate Disodium JAN USAN Ibandronic Acid Ibandronic Sodium USAN Phase II/III PhaseII 2008/10/21 Pamidronic Acid Pamidronate Disodium JAN USAN Risedronic Acid Sodium Risedronate Hydrate JAN Risedronate Sodium 2008/12/25 5 USAN Tiludronic Acid Tiludronate Disodium USAN Zoledronic Acid 2008 12/25 R03 FDA Epoetin alfa Procrit / Epogen darbepoetin alfa Aranesp Medication Guide Q&A Questions and answers on medication guides for erythropoiesis-stimulating agents ESAs epoetin alfa Procrit / Epogen and darbepoetin alfa Aranesp FDA MedWatch Questions and Answers 2008/12/02 #ESA2 FDA MedWatch FDA epoetin alfa Procrit / Epogen darbepoetin alfa Aranesp Medication Guide *1 Q&A Medication Guide ESA Erythropoiesis-Stimulating Agent Medication Guide ESA ESA Questions and Answers ESA ESA

6 ESA HIV zidovudine ESA ESA ESA 2008/12/25 6 FDA ESA ESA ESA ESA quality of life ESA ESA ESA >12g/dL ESA ESA ESA vascular access Medication Guide ESA Medication Guide 1 Medication Guide Procrit Epogen Aranesp FDA 2008/10/02 2008/12/25 7 Epoetin Alfa Darbepoetin Alfa 2008 12/25 R04

7 Health Canada Alemtuzumab MabCampath B 6 Infection-related deaths reported with the use of MabCampath alemtuzumab as consolidation therapy following chemoimmunotherapy in B-cell chronic lymphocytic leukemia Notice to Hospitals 2008/11/18 Web 2008/11/21 Bayer HealthCare Genzyme Bayer HealthCare Genzyme Health Canada alemtuzumab MabCampath MabCampath B B-CLL fludarabine MabCampath CALGB10101 A 3 fludarabine + rituximab MabCampath 51 6 1 A CALGB10101 URL 2008/12/25 8 *1 CALGB10101 II B-CLL fludarabine + rituximab FR MabCampath Fludarabine 4 MabCampath 1 3 mg 3 10 mg 5 30 mg 6 6 1 30 mg 3 6 CMV PCP EBV 1 Bayer HealthCare Genzyme

8 TAGVHD Bayer HealthCare Genzyme CLL MabCampath CALGB10101 MabCampath Fludarabine rituximab MabCampath MabCampath CALGB10101 Bayer HealthCare Genzyme B-CLL MabCampath MabCampath MabCampath 1 Lin et al.

9 , Consolidation Therapy with Subcutaneous SC Alemtuzumab Results in Severe Infections Toxicity in Previously Untreated CLL Patients Who Achieve a Complete Response CR after Fludarabine and Rituximab FR Induction Therapy: Interim Safety Analysis of the CALGB Study 10101. Blood ASH Annual Meeting Abstracts 2007 110: Abstract 755. CALGB10101 2008/12/25 9 1 CALGB10101 MHRA 2008/04/17 Alemtuzumab CD52 TGA 2008 12/26 R05 EU EMEA Rimonabant Acomplia EMEA The European Medicines Agency recommends suspension of the marketing authorisation of rimonabant Acomplia Press Release Questions and Answers 2008/10/23 Press Release EMEA Sanofi-Aventis rimonabant Acomplia EMEA CHMP Acomplia EU Acomplia / 2006 6 EU

10 Product Information Acomplia CHMP Acomplia / 10 20 23 Acomplia / 2 2008/12/25 10 CHMP CHMP CHMP Acomplia Acomplia Acomplia