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Post-marketing Safety Measures

MHLW Pharmaceuticals and Medical Devices Safety Information FY2013

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FY 2013 (No.301-311)
Japanese
version
issued
on		 No. Table of contents PDF
March 26, 2014 311
  1. Revised Adverse Reaction Reporting System for Quasi-drugs and Cosmetics
  2. Important Safety Information
    (1)Salazosulfapyridine
    (2)Sulfamethoxazole/Trimethoprim
    (3)Felbinac (for ethical use)
    (4)Regorafenib Hydrate
  3. Revision of Precautions (No. 254)
    (1)Mianserin Hydrochloride (and 5 others)
  4. List of Products Subject to Early Post-marketing Phase Vigilance (as of March 2014)
 Full text [291 KB]
February 27, 2014 310
  1. Thrombosis with YAZ Combination Tablets for Dysmenorrhea
  2. Rivaroxaban and Interstitial Pneumonia
  3. Direct Patient Reporting System for Adverse Drug Reactions
  4. Important Safety Information
    (1)Atazanavir Sulfate
    (2)Crizotinib
    (3)Clopidogrel Sulfate-containing Products
    (4)Sodium Valproate
    (5)Drospirenone/Ethinylestradiol Betadex
    (6)Rivaroxaban
  5. Revision of Precautions (No. 253)
    (1)Rufinamide (and 8 others)
  6. List of Products Subject to Early Post-marketing Phase Vigilance (as of February 2014)
 Full text [647 KB]
January 29, 2014 309
  1. Precautions for Use of Puncture Site Closure Devices
  2. List of Products Subject to Early Post-marketing Phase Vigilance (as of January 2014)
(Reference)
Drugs and Medical Devices Safety Information Reporting System		 Full text [322 KB]
December 26, 2013 308
  1. Review of Driving Precautions in Package Inserts of Ethical Drugs
  2. Important Safety Information
    (1)Bosentan Hydrate
  3. Revision of Precautions (No. 252)
    (1)Donepezil Hydrochloride (and 5 others)
  4. List of Products Subject to Early Post-marketing Phase Vigilance (as of December 2013)
(Reference)
Handling of Fire during Long-term Oxygen Therapy		 Full text [355 KB]
November 28, 2013 307
  1. 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
  2. Important Safety Information
    (1)Axitinib
    (2)Bevacizumab (Genetical Recombination)
  3. Revision of Precautions (No. 251)
    (1)Clobazam (and 9 others)
  4. List of Products Subject to Early Post-marketing Phase Vigilance (as of November 2013)
 Full text [606 KB]
October 30, 2013 306
  1. Adverse Reactions to Influenza Vaccine in the 2012 Season
  2. Important Safety Information
    (1)Propylthiouracil
    (2)Bortezomib
    (3)Minocycline Hydrochloride (oral dosage form, injectable dosage form)
    (4)Losartan Potassium
  3. Revision of Precautions (No. 250)
    (1)Celecoxib (and 4 others)
    (2)Tracheostomy Masks
  4. List of Products Subject to Early Post-marketing Phase Vigilance (as of October 2013)
 Full text [407 KB]
September 25, 2013 305
  1. Hydroxyethyl Starch-containing Solutions and Renal Impairment
  2. Project of Japan Drug Information Institute in Pregnancy
  3. Important Safety Information
    (1)Alogliptin Benzoate-containing products
    (2)Valsartan-containing products
    (3)Vildagliptin
    (4)Orengedokuto, Kamishoyosan and Shin' iseihaito
  4. Revision of Precautions (No. 249)
    Isoflurane (and 13 others)
  5. List of Products Subject to Early Post-marketing Phase Vigilance (as of September 2013)
 Full text [662 KB]
August 28, 2013 304
  1. Surveillance on Availability, Dissemination, and Utilization of Drug Safety Information in Medical Institutions and Pharmacies
  2. Important Safety Information
    (1)Golimumab (Genetical Recombination)
  3. Revision of Precautions (No. 248)
    Paliperidone (and 5 others)
  4. List of Products Subject to Early Post-marketing Phase Vigilance (as of August 2013)
 Full text [687 KB]
July 31, 2013 303
  1. Tolvaptan and Hepatic Dysfunction
  2. Revision of Precautions for Magnetic Resonance Imaging System
  3. Important Safety Information
    (1)Interferon beta (Products for administration in combination with ribavirin) and Ribavirin (Capsules)
    (2)Carboplatin
    (3)Tegafur / Gimeracil / Oteracil Potassium
    (4)Tolvaptan
    (5)Paroxetine Hydrochloride Hydrate
    (6)Levetiracetam
  4. Revision of Precautions (No. 247)
    Loxoprophen sodium hydrate (oral dosage form) (and 4 others)
  5. List of Products Subject to Early Post-marketing Phase Vigilance (as of July 2013)
 Full text [505 KB]
June 26, 2013 302
  1. Severe Haemorrhages Associated with Suspected Interaction between Antirheumatic Iguratimod and Warfarin
  2. Revision of Precautions for the Effect of Battery Chargers for Electric Cars on Implantable Cardiac Pacemakers
  3. Important Safety Information
    (1)Ambrisentan
    (2)Tranexamic Acid
    (3)Iguratimod
  4. Revision of Precautions (No. 246)
    (1)Tolvaptan (and 12 others)
    (2)Magnetic Resonance Imaging
  5. List of Products Subject to Early Post-marketing Phase Vigilance (as of June 2013)
 Full text [475 KB]
May 28, 2013 301
  1. Precautions in Handling of Reusable Resuscitator
  2. Important Safety Information
    (1)Recombinant Absorbed Bivalent Human Papillomavirus-like Particle Vaccine (derived from Trichoplusia ni cells)
    (2)Telaprevir
  3. Revision of Precautions (No. 245)
    (1)Gabapentin (and 19 others)
    (2)Implantable Cardiac Pacemaker, Biventricular Pacing Pulse Generator without Defibrillator Function
  4. List of Products Subject to Early Post-marketing Phase Vigilance (as of May 2013)
 Full text [744 KB]