MHLW Pharmaceuticals and Medical Devices Safety Information (FY2014)

**FY 2014 (No.312-321)**
Japanese version issued on	No.	Table of contents	PDF
March 30, 2015	321	Lamotrigine and Serious Skin Disorders Abiraterone Acetate and Hypokalaemia The MIHARI Project Important Safety Information (1)abiraterone acetate (2)lamotrigine (3)apixaban (4)memantine hydrochloride Revision of Precautions (No. 263) Montelukast sodium and telaprevir List of Products Subject to Early Post-marketing Phase Vigilance (as of March 2015) (Reference) 　The Drug and Medical Devices Safety Information Reporting System – Reporting via e-Gov was closed	Full text [364 KB]
January 29, 2015	320	Cabazitaxel Acetonate and Severe Febrile Neutropenia Use of Capsule Endoscopy for Small Intestine Screening in Pediatrics and Geriatrics Important Safety Information (1)cabazitaxel acetonate (2)sodium-glucose co-transporter 2 inhibitors (3)freeze-dried live attenuated mumps virus vaccine (4)levetiracetam Revision of Precautions (No. 262) Linagliptin (and 2 others) List of Products Subject to Early Post-marketing Phase Vigilance (as of January 2015)	Full text [329 KB]
December 24, 2014	319	Summary of the Relief System for Sufferers from Adverse Drug Reactions and the Cases of Non-payment of Relief Benefits Due to Improper Use of Drugs Revision of Precautions (No. 261) List of Products Subject to Early Post-marketing Phase Vigilance (as of December 2014) (Reference) 　Handling of Fire during Long-term Oxygen Therapy	Full text [583 KB]
November 25, 2014	318	Simeprevir Sodium and Hyperbilirubinaemia Surveillance on Access to, Dissemination, and Utilization of Drug Safety Information in Medical Institutions and Pharmacies Adverse Reactions to Influenza Vaccine in the 2013 Season Important Safety Information (1)Enzalutamide (2)Teneligliptin hydrobromide hydrate (3)Vancomycin hydrochloride (for injection) (4)Simeprevir sodium Revision of Precautions (No. 260) Acetaminophen and vancomycin hydrochloride (oral dosage form) List of Products Subject to Early Post-marketing Phase Vigilance (as of November 2014)	Full text [1.2 MB]
October 28, 2014	317	Guidelines for Use of Mobile Phones and Other Devices in Hospitals Change in the Submission Place of Reports in the Safety Information Reporting System Important Safety Information (1)Imatinib mesilate (2)Pregabalin List of Products Subject to Early Post-marketing Phase Vigilance (as of October 2014)	Full text [394 KB]
September 30, 2014	316	Project of Japan Drug Information Institute in Pregnancy Effects of Angiotensin II Receptor Blockers and Angiotensin Converting Enzyme Inhibitors on Pregnant Women and Foetuses Revision of Precautions (No. 259) Paroxetine Hydrochloride Hydrate (and 9 others) List of Products Subject to Early Post-marketing Phase Vigilance (as of September 2014)	Full text [524 KB]
August 26, 2014	315	Safety Measures of New Drugs during the Early Post-marketing Phase Important Safety Information (1)Inchinkoto (2)Simeprevir Sodium (3)Teriparatide (Genetical Recombination) (4)Loratadine Revision of Precautions (No. 258) Paroxetine Hydrochloride Hydrate (and 3 others) List of Products Subject to Early Post-marketing Phase Vigilance (as of August 2014)	Full text [315 KB]
July 29, 2014	314	Revision of Report Form in Drugs and Medical Devices Safety Information Reporting System Revision of Precautions (No. 257) (1)Azilsartan (and 7 others) List of Products Subject to Early Post-marketing Phase Vigilance (as of July 2014)	Full text [199 KB]
May 27, 2014	313	Fatal cases with XEPLION® Aqueous Suspension for IM injection Important Safety Information (1)Paliperidone Palmitate Revision of Precautions (No. 256) (1)Pentamidine Isetionate List of Products Subject to Early Post-marketing Phase Vigilance (as of May 2014)	Full text [186 KB]
April 30, 2014	312	Use of Topical Ketoprofen during Pregnancy Important Safety Information (1)Ketoprofen (tapes) (2)Paclitaxel (excluding paclitaxel protein-bound particles for injectable suspension) (3)Levetiracetam Revision of Precautions (No. 255) (1)Ketoprofen (injectable dosage form, suppository) (and 7 others) List of Products Subject to Early Post-marketing Phase Vigilance (as of April 2014)	Full text [324 KB]