MHLW Pharmaceuticals and Medical Devices Safety Information (FY2012)

1. Implementation of the "Risk Management Plan"
2. Revision of Precautions (No. 244)
   Estradiol (ESTRANA, Julina, DIVIGEL, FEMIEST) (and 4 others)
3. List of Products Subject to Early Post-marketing Phase Vigilance (as of March 2013)

1. Utilization of the PMDA Medical Safety Information
2. Important Safety Information

   (1)Zanamivir Hydrate

   (2)Josamycin, Josamycin Propionate

   (3)Sunitinib Malate

   (4)Ryutanshakanto (for Ethical Use)

3. Revision of Precautions (No. 243)
   Glimepiride, Pioglitazone Hydrochloride / Glimepiride (and 4 others)
4. List of Products Subject to Early Post-marketing Phase Vigilance (as of February 2013)

Adverse Drug Reaction Term "Anaphylaxis"

1. Partial Amendment of the "Guidance for Bar Code Labeling on Prescription Drugs" for the Prevention of Medical Accidents
2. Important Safety Information

   (1)Temozolomide

   (2)Telaprevir

   (3)Pramipexole Hydrochloride Hydrate

   (4)Mogamulizumab

3. Revision of Precautions (No. 242)
   Digoxin, Deslanoside, and Methyldigoxin (and 5 others)
4. List of Products Subject to Early Post-marketing Phase Vigilance (as of January 2013)

1. Surveillance on Dissemination and Utilization of Safety Information in Medical Institutions
2. Precautions for Using Gastrointestinal Stents
3. List of Products Subject to Early Post-
   marketing Phase Vigilance (as of December 2012)

1. Summary of Payment / Non-payment of Adverse Drug Reaction Relief Benefits and Drugs with Many Cases of Improper Use
2. Important Safety Information

   (1)Imatinib Mesilate

   (2)Ceftriaxone Sodium Hydrate

   (3)Mexiletine Hydrochloride

3. Revision of Precautions (No. 241)
   Inactivated Poliomyelitis Vaccine (and 4 others)
4. List of Products Subject to Early Post-marketing Phase Vigilance (as of November 2012)

1. Serious Hypocalcaemia Associated with Denosumab (Genetical Recombination)
2. Important Safety Information

   (1)Denosumab (Genetical Recombination)

   (2)Tetracosactide Acetate (0.5 mg preparation)

   (3)Levocabastine Hydrochloride

3. Revision of Precautions (No. 240)
   Diclofenac Sodium (ophthalmic solution) (and 9 others)
4. List of Products Subject to Early Post-marketing Phase Vigilance (as of October 2012)

1. Proper Use of Contact Lenses and Prevention of Eye Disorders
2. Summary of Report on Adverse Reactions to the Influenza Vaccine in the 2011 Season
3. Important Safety Information

   (1)Oxaliplatin

4. Revision of Precautions (No. 239)
   Suxamethonium Chloride Hydrate (and 6 others)
5. List of Products Subject to Early Post-marketing Phase Vigilance (as of September 2012)

1. Serious Adverse Reactions Associated with Over-the-counter Drugs
2. Important Safety Information

   (1)Pregabalin

   (2)Methotrexate (Tablet 2 mg, Capsule)

   (3)Influenza HA Vaccine

3. Revision of Precautions (No. 238)
   Metformin Hydrochloride (and 9 others)
4. List of Products Subject to Early Post-marketing Phase Vigilance (as of Aug 2012)

1. Launch of a pilot program of "Direct Patient Reporting System for Adverse Drug Reactions"
2. Important Safety Information

   (1)Ivermectin

   (2)Telaprevir

   (3)Garenoxacin Mesilate Hydrate

3. Revision of Precautions (No. 237)
   Escitalopram Oxalate (and 6 others)
4. List of Products Subject to Early Post-marketing Phase Vigilance (as of July 2012)

1. Safety Measures for Cervical Cancer Prevention Vaccines
2. Important Safety Information

   (1)Alogliptin Benzoate, Alogliptin Benzoate / Pioglitazone Hydrochloride, Sitagliptin Phosphate Hydrate, Vildagliptin, Linagliptin

   (2)Exenatide, Liraglutide (Genetical Recombination)

   (3)Mosapride Citrate Hydrate

   (4)Iodine

3. Revision of Precautions (No. 236)
   Ibuprofen (oral dosage form) (and 29 others)
4. List of Products Subject to Early Post-marketing Phase Vigilance (as of June 2012)

1. Lookback Study on Blood Products for Transfusion
2. Drug-induced Serious Skin Disorders
3. Important Safety Information

   (1)Products Containing Acetaminophen

   (2)Cibenzoline Succinate

   (3)Triclofos Sodium, Chloral Hydrate

   (4)Metformin Hydrochloride (products with "Dosage and Administration" of maximum daily dosage of 2250 mg)

4. Revision of Precautions (No. 235)
   Pioglitazone Hydrochloride / Metformin Hydrochloride (and 14 others)
5. List of Products Subject to Early Post-marketing Phase Vigilance (as of April 2012)

Increase of the Number of Cooperating Hospitals in the Project for "Japan Drug Information Institute in Pregnancy"