Pmda - Pharmaceuticals and Medical Devices Agency

Post-marketing Safety Measures

MHLW Pharmaceuticals and Medical Devices Safety Information (FY2004)

FY 2004 (No.200-211)

No. Table of contents Posted
March 31, 2005 211
  1. Important Safety Information

    (1)Raloxifene Hydrochloride

    (2)Quetiapine Fumarate

    (3)Blood Glucose Self-monitoring Kit (those using the glucose dehydrogenase method and coenzyme pyroloquinoline quinone)

  2. Revision of PRECAUTIONS (No. 164)
    Trandolapril (and 4 others)
  (Full text)
February 24, 2005 210
  1. Leflunomide-related interstitial pneumon
  2. Important Safety Information

    (1)Epirubicin Hydrochloride

    (2)Freeze-dried Sulfonated Human Normal Immunoglobulin, pH4 Treated Acidic Human Normal Immunoglobulin, Polyethylene Glycol Treated Human Normal Immunoglobulin, Freeze-dried Polyethylene Glycol Treated Human Normal Immunoglobulin


    (4)Prednisolone (oral dosage form)


  3. Revision of PRECAUTIONS (No. 163)
    Mefenamic Acid (and 11 others)
  (Full text)
January 27, 2005 209
  1. Important Safety Information


  2. Revision of PRECAUTIONS (No. 162)
    Lisinopril (and 8 others)
  (Full text)
December 21, 2004 208
  1. Important Safety Information

    (1)Interferon Alfa (NAMALWA)


  2. Revision of PRECAUTIONS (No. 161)
    Amitriptyline Hydrochloride (and 13 others)
  (Full text)
November 25, 2004 207
  1. Important Safety Information


    (2)Sodium Rabeprazole

  2. Revision of PRECAUTIONS (No. 160)
    Flurbiprofen (oral dosage form) (and 13 others)
  (Full text)
October 28, 2004 206
  1. Safety measures for shock etc. due to injectable antibiotics etc.
  2. Reports on Iressa Tablets 250 prospective study (special investigation)
  3. Safety measures for blood glucose monitoring kits
  (Full text)
September 30, 2004 205
  1. Reports on adverse reactions associated with influenza vaccines in FY2003
  2. Post-marketing safety measures for ticlopidine hydrochloride products and Cypher Stent
  3. Important Safety Information

    (1)Tacrolimus Hydrate (oral dosage form, injectable dosage form)

  4. Revision of PRECAUTIONS (No. 159)
    Sevoflurane (and 14 others)
  (Full text)
August 26, 2004 204
  1. Important Safety Information


    (2)Mosapride Citrate

    (3)Salicylamide / Acetaminophen / Anhydrous Caffeine / Promethazine Methylenedisalicylate

    (4)Concentrated Glycerin / Fructose

  2. Revision of PRECAUTIONS (No. 158)
    Cabergoline (and 12 others)
  (Full text)
July 29, 2004 203
  1. Serious skin disorders caused by pharmaceuticals
  2. Effects of electromagnetic waves from antitheft devices, etc. on medical devices
  3. Important Safety Information

    (1)Monoethanolamine Oleate


    (3)Tegafur / Gimeracil / Oteracil Potassium

    (4)Melphalan (injectable dosage form)

  4. Revision of PRECAUTIONS (No. 157)
    Milnacipran Hydrochloride (and 6 others)
  (Full text)
June 24, 2004 202
  1. Safety measures relating to pharmaceuticals with high risks resulting from mix-ups
  2. Important Safety Information

    (1)Infliximab (Genetical recombination)

    (2)Imatinib Mesilate

    (3)Oseltamivir Phosphate

  3. Revision of PRECAUTIONS (No. 156)
    Tandospirone Citrate (and 5 others)
  (Full text)
May 27, 2004 201
  1. Important Safety Information

    (1)Clofedanol Hydrochloride

    (2)Flavoxate Hydrochloride

    (3)Vinorelbine Ditartrate


    (5)Fluorouracil (injectable dosage form)

    (6)Doxazosin Mesilate

    (7)Sodium Risedronate Hydrate

  2. Revision of PRECAUTIONS (No. 155)
    Lornoxicam (and 18 others)
  (Full text)
April 22, 2004 200
  1. Prevention of overdose by use of OptiPen Pro-1 (insulin self-injection device)
  2. Crude drugs and drug products with possible adverse reaction when mistakenly imported due to the similarity in names
  3. Change of URL in response to the establishment of the Pharmaceuticals and Medical Devices Agency
  4. Health hazard caused by natural health foods and non-approved drugs
  (Full text)