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Pharmaceuticals and Medical Devices Safety Information No Pharmaceuticals and Medical Devices Safety Information No. 279 May 2011 Table of Contents 1. Project of Japan Drug Information Institute in Pregnancy ............... 6 2. Safety Measures Related to Lenalidomide Hydrate ........................ 11 3. Important Safety Information .................................................................... 17 (1) Aripiprazole ................................................................................................... 17 (2) Freeze-dried Live Attenuated Mumps Vaccine ............................................ 20 (3) Anti-human Thymocyte Immunoglobulin, Rabbit ......................................... 22 (4) Tacrolimus Hydrate (oral and injectable dosage form) ................................ 31 (5) Tolvaptan ...................................................................................................... 34 (6) Pioglitazone Hydrochloride, Pioglitazone Hydrochloride/Glimepiride, Pioglitazone Hydrochloride/Metformin Hydrochloride .................................. 38 4. Revision of Precautions (No. 225) .......................................................... 42 Sanilvudine (and 32 others) ............................................................................... 42 5. List of Products Subject to Early Post-marketing Phase Vigilance .................................................. 57 This Pharmaceuticals and Medical Devices Safety Information (PMDSI) is issued based on safety information collected by the Ministry of Health, Labour and Welfare (MHLW). It is intended to facilitate safer use of pharmaceuticals and medical devices by healthcare providers. The PMDSI is available on the Pharmaceuticals and Medical Devices Agency (PMDA) website (http://www.pmda.go.jp/english/index.html) and on the MHLW website (http://www.mhlw.go.jp/, only available in Japanese language). Published by Translated by Pharmaceutical and Food Safety Bureau, Pharmaceuticals and Medical Devices Agency Ministry of Health, Labour and Welfare Pharmaceutical and Food Safety Bureau, Office of Safety I, Ministry of Health, Labour and Welfare Pharmaceuticals and Medical Devices Agency 1-2-2 Kasumigaseki, Chiyoda-ku, Tokyo 3-3-2 Kasumigaseki, Chiyoda-ku, Tokyo 100-8916 Japan 100-0013 Japan E-mail: [email protected] This English version of PMDSI is intended to be a reference material to provide convenience for users. In the event of inconsistency between the Japanese original and this English translation, the former shall prevail. The PMDA shall not be responsible for any consequence resulting from use of this English version. Pharmaceuticals and Medical Devices Safety Information No. 279 May 2011 Pharmaceutical and Food Safety Bureau, Ministry of Health, Labour and Welfare, Japan [ Outline of Information ] No. Subject Measures Outline of Information Page MHLW established Japan Drug Information Institute in Pregnancy (JDIIP) at the National Center for Child Health and Development Project of Japan Drug (NCCHD) in October 2005 to provide consultation 1 Information Institute in services and perform research activities. Four 6 Pregnancy hospitals that joined the Project in FY2011 to strengthen the system are introduced together with the outline and current status of the project. The details are described in this section. Lenalidomide hydrate was originally approved for concomitant use with dexamethasone for the indication for treatment of patients with relapsed or refractory multiple myeloma in June 2010. In August 2010, the additional indication for treatment of patients with myelodysplastic syndrome associated with a chromosome 5q deletion was approved. During the Early Post-marketing Phase Vigilance Safety Measures (EPPV) in Japan (July 20, 2010 to February 19, P 2 Related to Lenalidomide 2011), a number of adverse drug reaction (ADR) 11 C Hydrate reports concerning infection and hepatic dysfunction were gathered. In January 2011, arterial thromboembolism such as cerebral infarction was added to the European Summaries of Product Characteristics. Based on the above, the safety measures related to infection, hepatic dysfunction and cerebral infarction associated with lenalidomide hydrate were reviewed. The details are described in this section. This section presents the contents of the revisions and case summaries that served as the basis for these Aripiprazole P revisions to important adverse reactions included 3 17 (and 5 others) C under the Precautions section of package inserts of drugs that have been revised in accordance with the Notification dated March 22, 2011. Sanilvudine 4 Revision of Precautions (No. 225) 42 (and 32 others) List of Products Subject Lists products subject to Early Post-marketing 5 to Early Post-marketing 57 Phase Vigilance as of May 1, 2011. Phase Vigilance D: Distribution of Dear Healthcare Professional Letters P: Revision of Precautions C: Case Reports Pharmaceuticals and Medical Devices Safety Information No. 279 - 2 - May2011 PMDA medi-navi (Pharmaceuticals and Medical Devices Information E-mail Alert Service) The PMDA is providing the “PMDA medi-navi” a Pharmaceuticals and Medical Devices Information E-mail Alert Service (only available in Japanese language), when important safety information regarding pharmaceuticals and medical devices including Dear Healthcare Professional Letters or Revision of Precautions is issued. This e-mail service will enable you to obtain safety information faster and more efficiently, free of charge. Please feel free to use this service for your faster information collection. See our website for details of the service. http://www.info.pmda.go.jp/info/idx-push.html Reporting of safety information such as adverse reactions to the Minister of Health, Labour and Welfare is a duty of medical and pharmaceutical providers. If medical and pharmaceutical providers such as physicians, dentists, and pharmacists detect adverse reactions, infections associated with drugs or medical devices, or medical device adverse events, it is mandatory for such providers to report them to the Minister of Health, Labour and Welfare directly or through the marketing authorization holder. As medical and pharmaceutical providers, drugstore and pharmacy personnel are also required to report safety issues related to drugs and medical devices. Pharmaceuticals and Medical Devices Safety Information No. 279 - 3 - May2011 Abbreviations ADEM Acute disseminated encephalomyelitis ADRs Adverse drug reactions Al-P Alkaline phosphatase ALT (GPT) Alanine aminotransferase (Glutamate pyruvate transaminase) Anti-AchR Anti-acetylcholine receptor AST (GOT) Aspartate aminotransferase (Glutamate oxaloacetate transaminase) BiPAP Bilevel positive airway pressure BUN Blood urea nitrogen CD4 Cluster of differentiation 4 CHDF Continuous hemodiafiltration CK (CPK) Creatine kinase (Creatine phosphokinase) Cl Chloride CMV Cytomegalovirus CRP C-reactive protein CT Computed tomography CY Cyclophosphamide ECG Electrocardiogram EPPV Early Post-marketing Phase Vigilance FLAIR Fluid-attenuated inversion recovery FN Febrile neutropenia FY Fiscal year GVHD Graft-versus-host disease HBs Hepatitis B surface HBV Hepatitis B virus HBV-DNA Hepatitis B virus deoxyribonucleic acid HIV Human immunodeficiency virus HIV-1 RNA Human immunodeficiency virus type 1 ribonucleic acid HLA Human leukocyte antigen HLGT High level Group Term HR Heart rate ICU Intensive care unit IgG Immunoglobulin G IgM Immunoglobulin M IPSS International Prognostic Scoring System IU International unit JDIIP Japan Drug Information Institute in Pregnancy K Potassium KIR Killer immunoglobulin-like receptor LDH Lactate dehydrogenase MAH Marketing authorization holder MedDRA Medical Dictionary for Regulatory Activities MG Myasthenia gravis MGFA Myasthenia Gravis Foundation of America MRI Magnetic resonance imaging Pharmaceuticals and Medical Devices Safety Information No. 279 - 4 - May2011 Na Sodium NCCHD National Center for Child Health and Development NCCN National Comprehensive Cancer Network Nel Nelarabine OTC Over-the-counter drug PLT Platelet PML Progressive multifocal leukoencephalopathy PS Performance status PT Preferred Term PT Prothrombin time QOL Quality of life RBC Red blood cell count RIST Reduced-intensity stem cell transplantation SIADH Syndrome of inappropriate secretion of antidiuretic hormone SmPC Summary of Product Characteristics SOC System Organ Class SpO2 Oxygen saturation TEN Toxic epidermal necrolysis VP-16 Etoposide WBC White blood cell count -GTP gamma-glutamyl transpeptidase Pharmaceuticals and Medical Devices Safety Information No. 279 - 5 - May2011 1 Project of Japan Drug Information Institute in Pregnancy 1. Project of Japan Drug Information Institute in Pregnancy When using drugs during pregnancy, sufficient attention should be paid to their influence on the fetus as well as the mother. On the other hand, because of excessive anxiety about drug-related risks, some physicians withhold necessary drug therapies or some patients stop taking medications without physician's advice, although few drugs have been confirmed to have teratogenic effects on humans. Suspension of necessary medication may result in aggravation of the mother’s condition and adversely affect the fetus. Some patients even give up trying to get pregnant because they are on medication for treatment of chronic diseases. To prevent such occurrences, MHLW established Japan Drug Information Institute in Pregnancy (JDIIP) (http://www.ncchd.go.jp/kusuri) in the National Center for Child Health and Development (NCCHD) on October 2005 to collect and evaluate
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