MHLW Pharmaceuticals and Medical Devices Safety Information (FY2015)

**FY 2015 (No.322-331)**
Japanese version issued on	No.	Table of contents	PDF
March 15, 2016	331	“Children and Medicines” Data Collecting Network Development Project Important Safety Information (1)Eribulin mesilate Revision of Precautions (No. 272) Methylphenidate hydrochloride (and 2 others) List of Products Subject to Early Post-marketing Phase Vigilance (as of February 2016)	Full text [326 KB]
February 9, 2016	330	Preventative Measures for Accidental Ingestion of Pharmaceuticals by Children Important Safety Information (1)Amlodipine besilate (2)Itraconazole Revision of Precautions (No. 271) Azilsartan(and 12 others) List of Products Subject toEarly Post-marketing Phase Vigilance (as of December 2015)	Full text [318 KB]
January 7, 2016	329	Adverse Reaction to Influenza Vaccine in the 2014 Season Safety of Influenza Antiviral Drugs Important Safety Information (1)Lenvatinib mesilate Revision of Precautions (No. 270) Fomepizole (and 3 others) List of Products Subject to Early Post-marketing Phase Vigilance (as of November 2015) (Reference) Precautions Regarding Handling of Fire during Long-Term Oxygen Therapy (LOT)	Full text [320 KB]
December 1, 2015	328	Hypermagnesaemia caused by magnesium oxide Summary of the Relief System for Sufferers from Adverse Drug Reaction and Cases of Non-payment of Relief Benefits Due to Improper Use of Drugs The Japan Drug Information Institute in Pregnancy Important Safety Information (1)asunaprevir and daclatasvir hydrochloride Revision of Precautions (No. 269) Galantamine hydrobromide (and 4 others) List of Products Subject to Early Post-marketing Phase Vigilance (as of October 2015)	Full text [701 KB]
October 27, 2015	327	Utilization of Blood Glucose Meters, etc. that Use Enzymatic Electrodes Precautions Concerning Recurrent and Similar Incidents of Medical Accidents Important Safety Information (1)asunaprevir and daclatasvir hydrochloride (2)amantadine hydrochloride (3)nivolumab (genetical recombination) (4)sodium-glucose co-transporter 2 (SGLT2) inhibitors Revision of Precautions (No. 268) Fingolimod hydrochloride and azithromycin hydrate List of Products Subject to Early Post-marketing Phase Vigilance (as of September 2015)	Full text [226 KB]
September 15, 2015	326	Epidemiological Survey on Vaccination and Sudden Death of Infants Important Safety Information (1)sterile talc (2)panitumumab (genetical recombination) Revision of Precautions (No. 267) Hydroxyzine hydrochloride and hydroxyzine pamoate (and 4 others) List of Products Subject to Early Post-marketing Phase Vigilance (as of August 2015)	Full text [835 KB]
August 6, 2015	325	Surveillance on Access to, Dissemination, and Utilization of Drug Safety Information in Medical Institutions Important Safety Information (1)asunaprevir and daclatasvir hydrochloride (2)abiraterone acetate (3)indapamide (4)influenza HA vaccine (5)interferon beta-1a (genetical recombination) Revision of Precautions (No. 266) Tramadol hydrochloride (OD tablets, capsules, and injections) and tramadol hydrochloride/acetaminophen (and 2 others) List of Products Subject to Early Post-marketing Phase Vigilance (as of June 2015)	Full text [543 KB]
July 7, 2015	324	Risk Management Plan Important Safety Information (1)crizotinib (2)technetium (^99mTc) hydroxymethylenediphosphonate injection, kit for the preparation of technetium (^99mTc) hydroxymethylenediphosphonate injection List of Products Subject to Early Post-marketing Phase Vigilance (as of May 31, 2015)	Full text [230 KB]
May 26, 2015	323	Utilization of New Bar Code Labeling and Termination of JAN/ITF Code Labeling on Prescription Drugs Important Safety Information (1)asunaprevir and daclatasvir hydrochloride Revision of Precautions (No. 265) Duloxetine hydrochloride (and 4 others) List of Products Subject to Early Post-marketing Phase Vigilance (as of April 30,2015)	Full text [221 KB]
April 28, 2015	322	Adherence to the Cleaning and Disinfection Method to Prevent Transmission of Multidrug-resistant Bacteria by Duodenoscope Important Safety Information (1)cyclophosphamide hydrate (2)sitagliptin phosphate hydrate (3)triamcinolone acetonide (intramuscular, intra-articular, and intradermal) (4)pazopanib hydrochloride (5)panitumumab (genetical recombination) Revision of Precautions (No. 264) Rebamipide (ophthalmic suspension) (and 2 others) List of Products Subject to Early Post-marketing Phase Vigilance (as of April 2015) (Reference) Precautions Concerning Recurrence and Similar Incidents of Medical Accidents	Full text [210 KB]