MHLW Pharmaceuticals and Medical Devices Safety Information FY2013

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)

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)

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

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

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)

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)

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)

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)

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)

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)

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)