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Post-marketing Safety Measures

MHLW Pharmaceuticals and Medical Devices Safety Information (FY2007)

FY 2007 (No.235-245)

Japanese
version
issued
on
No. Table of contents Posted
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PDF
March 27, 2008 245
  1. Treatment of hepatitis viral with interferon products
  2. Sudden onset of sleep, etc. associated with non-ergoline dopamine agonists (patients must be advised to refrain from driving, etc.)
  3. Important Safety Information

    (1)Cyclophosphamide (oral dosage form), Cyclophosphamide(injectable dosage form)

  4. Revision of PRECAUTIONS (No. 195)
    Nicorandil (oral dosage form) and 1 other
  5. List of products subject to Early Post-marketing Phase Vigilance
  (Full text)
February 28, 2008 244
  1. Revision of PRECAUTIONS (No. 194)
    GEM-Premier 3000 PAK and 10 others
  2. List of products subject to Early Post-marketing Phase Vigilance
  (Full text)
January 29, 2008 243
  1. Revision of PRECAUTIONS (No. 193)
    Flurbiprofen (oral dosage form) and 6 others
  2. List of products subject to Early Post-marketing Phase Vigilance
<Reference>
  1. About oseltamivir phosphate (Tamiflu)
    <The brief summary of the review results by the Subcommittee on Drug Safety (held on December 25, 2007)>
  (Full text)
December 26, 2007 242
  1. Important Safety Information

    (1)Atorvastatin Calcium Hydrate

    (2)Tizanidine Hydrochloride

    (3)Thiamazole

  2. Revision of PRECAUTIONS (No. 192)
    Amitriptyline Hydrochloride and 11 others
  3. List of products subject to Early Post-marketing Phase Vigilance
  (Full text)
November 29, 2007 241
  1. "PMDA medical safety information" is new posted on the Pharmaceuticals and Medical Devices Information Website
  2. Important Safety Information

    (1)Amiodarone Hydrochloride (oral dosage form), Amiodarone Hydrochloride (injectable dosage form)

  3. Revision of PRECAUTIONS (No. 191)

    (1)Drugs: Pralidoxime Iodide and 13 others

    (2)Medical Devices: Glucose meters for self-monitoring and 5 others

  4. List of products subject to Early Post-marketing Phase Vigilance
  (Full text)
September 27, 2007 240
  1. Reports etc. on adverse reactions associated with influenza vaccines in FY 2006
  2. Revision of PRECAUTIONS (No. 190)

    (1)Telithromycin and (7 others)

    (2)Internal fluid pathway type needleless connectors and (1 other)

  3. List of products subject to Early Post-marketing Phase Vigilance
  (Full text)
August 30, 2007 239
  1. Important Safety Information

    (1)Alteplase (Genetical recombination)

    (2)Oxycodone Hydrochloride Hydrate

    (3)Meropenem Trihydrate

  2. Revision of PRECAUTIONS (No. 189)

    (1)Amobarbital and (7 others)

  3. List of products subject to Early Post-marketing Phase Vigilance
  (Full text)
July 31, 2007 238
  1. Important Safety Information

    (1)Zolpidem Tartrate

    (2)Zopiclone

  2. Revision of PRECAUTIONS (No. 188)

    (1)Triazolam and (2 others)

    (2)Enteral feeding tubes and gastric tubes (only those with stylet or guide wire as kits) and (2 others)

  3. List of products subject to Early Post-marketing Phase Vigilance
  (Full text)
June 27, 2007 237
  1. The effect from RFID devices in UHF band and mobile phone terminals with a new system on implantable medical devices such as cardiac pacemakers etc.
  2. Important Safety Information

    (1)Gadodiamide Hydrate

    (2)Cabergoline

    (3)Pergolide Mesilate

    (4)Risperidone

  3. Revision of PRECAUTIONS (No. 187)

    (1)Ampiroxicam (and 7 others)

    (2)Medical devices such as artificial lungs, blood pumps, and blood circuits etc. that consist of extra-corporeal circuit

  4. List of products subject to Early Post-marketing Phase Vigilance
<Reference>
  1. Manuals for Management of Individual Serious Adverse Drug Reaction
  2. Guidelines for Standard Methods of Extra-corporeal Circuit and Its Safety Training
  (Full text)
May 31, 2007 236
  1. Post-marketing safety measures for ticlopidine hydrochloride products and TAXUS Express2 Stent
  2. Important Safety Information

    (1)Edaravone

    (2)Amiodarone Hydrochloride (oral dosage form)

    (3)Cibenzoline Succinate (oral dosage form)

  3. Revision of PRECAUTIONS (No. 186)
    Oseltamivir Phosphate (and 11 others)
  4. List of products subject to Early Post-marketing Phase Vigilance
  (Full text)
April 26, 2007 235
  1. Standardization of the number of drops for infusion sets and blood transfusion sets
  2. Project of Japan Drug Information Institute in Pregnancy
  3. Safety Information on the "Pharmaceuticals and Medical Devices Information Website" of the Pharmaceuticals and Medical Devices Agency
  4. List of products subject to Early Post-marketing Phase Vigilance
<Reference>
  1. Oseltamivir Phosphate
  2. Overview of Pharmacogenomics
    (Warfarin therapy and genetic polymorphism)
  (Full text)