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Post-marketing Safety Measures

MHLW Pharmaceuticals and Medical Devices Safety Information (FY2012)

FY 2012 (No.290-300)

Japanese
version
issued
on
No. Table of contents Posted
on
PDF
Mar 27, 2013 300
  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)
Apr 3,
2013
(Summary)
Apr 24,
2013
(Full text)
Feb 27, 2013 299
  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)
<Reference>

Adverse Drug Reaction Term "Anaphylaxis"

Mar 1,
2013
(Summary)
Mar 26,
2013
(Full text)
Jan 30, 2013 298
  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)
Feb 1,
2013
(Summary)
Feb 27,
2013
(Full text)
Dec 26, 2012 297
  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)
Jan 8,
2013
(Summary)
Jan 30,
2013
(Full text)
Nov 27, 2012 296
  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)
Dec 5,
2012
(Summary)
Dec 27,
2012
(Full text)
Oct 31, 2012 295
  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)
Nov 2,
2012
(Summary)
Nov 27,
2012
(Full text)
Sept 26, 2012 294
  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)
Oct 2,
2012
(Summary)
Oct 26,
2012
(Full text)
Aug 29, 2012 293
  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)
Aug 30,
2012
(Summary)
Sept 25,
2012
(Full text)
July 25, 2012 292
  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)
July 31,
2012
(Summary)
Aug 29,
2012
(Full text)
June 27, 2012 291
  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)
July 4,
2012
(Summary)
July 25,
2012
(Full text)
April 25, 2012 290
  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)
<Reference>

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

May 8,
2012
(Summary)
May 30,
2012
(Full text)