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Post-marketing Safety Measures

MHLW Pharmaceuticals and Medical Devices Safety Information (FY2009)

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FY 2009 (No.257-267)

Japanese
version
issued
on		 No. Table of contents Posted
on		 PDF
March 31, 2010 267
  1. Precautions on handling of lancing devices for capillary blood sampling
  2. Important Safety Information

    (1)Bortezomib

    (2)Methotrexate

  3. Revision of PRECAUTIONS (No. 214)
    Warfarin Potassium (and 9 others)
  4. List of products subject to Early Post-marketing Phase Vigilance
 Apr. 27, 2010 (Full text)
February 24, 2010 266
  1. Proper proceudures for soft contact lens care
  2. Important Safety Information

    (1)Bicalutamide

    (2)Fludarabine phosphate

  3. Revision of PRECAUTIONS (No. 213)
    Amoxapine (and 11 others)
  4. List of products subject to Early Post-marketing Phase Vigilance
 Mar. 29, 2010 (Full text)
January 27, 2010 265
  1. Handling of fire during Long-term Oxygen Therapy
  2. Important Safety Information

    (1)Sorafenib tosilate

    (2)Aripiprazole, spiperone, sulpiride, zotepine, nemonapride, pipamperone hydrochloride, pimozide, moperone hydrochloride

    (3)Olanzapine, risperidone (oral dosage form), risperidone (injectable dosage form)

    (4)Quetiapine fumarate

    (5)Tandospirone citrate

  3. Revision of PRECAUTIONS (No. 212)
    Acemetacin (and 14 others)
  4. List of products subject to Early Post-marketing Phase Vigilance
 Mar. 3, 2010 (Full text)
December 25, 2009 264
  1. Safety measures for anaphylaxis and anaphylactoid symptoms associated with injectable antibiotics
  2. Important Safety Information

    (1)Salazosulfapyridine

    (2)Pethidine hydrochloride, pethidine hydrochloride / levallorphan tartrate

  3. Revision of PRECAUTIONS (No. 211)
    Indometacin (oral dosage form) (and 7 others)
  4. List of products subject to Early Post-marketing Phase Vigilance
 Jan. 29, 2010 (Full text)

November 27, 2009		 263
  1. Association between use of human insulin and insulin analogues and risk of cancer
  2. Important Safety Information

    (1)Ivermectin

    (2)Everolimus, gusperimus hydrochloride, cyclosporine (oral dosage form, injectable dosage form), tacrolimus hydrate (oral dosage form, injectable dosage form), basiliximab (genetical recombination), mycophenolate mofetil, muromonab-CD3

    (3)Ciprofloxacin, ciprofloxacin hydrochloride

    (4)Sunitinib malate

    (5)Sorafenib tosilate

    (6)Tegafur / gimeracil / oteracil potassium

    (7)Bevacizumab (genetical recombination)

    (8)Rosuvastatin calcium

  3. Revision of Precautions (No. 210)

    (1)Pancuronium bromide, vecuronium bromide, rocuronium bromide (and 7 others)

    (2)Blood circuits (and 3 others)

  4. List of products subject to Early Post-marketing Phase Vigilance
 Dec 24, 2009 (Full text)
October 28, 2009 262
  1. PMDA Medical Safety Information
  2. The Relief System for Sufferers from Adverse Drug Reactions and Disease Infected from Biological Products
  3. List of products subject to Early Post-marketing Phase Vigilance
 Nov 30, 2009 (Full text)
September 29, 2009 261
  1. Drug-associated serious skin disorders
  2. SSRIs / SNRIs and harmful behavior to others
  3. Important Safety Information

    (1)Varenicline tartrate

  4. Revision of PRECAUTIONS (No. 209)
    Cibenzoline succinate (oral dosage form) (and 7 others)
  5. List of products subject to Early Post-marketing Phase Vigilance
<Reference>
  1. Reports on adverse reactions associated with influenza vaccines in FY 2008
    (Conclusion of the Vaccine Adverse Reaction Review Committee)
 Oct 29, 2009 (Full text)
August 26, 2009 260
  1. Tricyclic and tetracyclic antidepressants, associated with aggression
  2. Important Safety Information

    (1)Telmisartan

    (2)Phenytoin, Phenytoin / Phenobarbital, Phenytoin / Phenobarbital / Caffeine and Sodium Benzoate, Phenytoin Sodium

  3. Revision of PRECAUTIONS (No. 208)
    Lamotrigine (and 9 others)
  4. List of Products Subject to Early Post-marketing Phase Vigilance
 Sep 10, 2009 (Full text)
July 30, 2009 259
  1. Important Safety Information

    (1)Monobasic Sodium Phosphate Monohydrate and Anhydrous Dibasic Sodium Phosphate

  2. Revision of PRECAUTIONS (No. 207)
    Blonanserin (and 4 others)
  3. List of products subject to Early Post-marketing Phase Vigilance
<Reference>
  1. About Oseltamivir Phosphate (Tamiflu)
    <The brief summary of the review results of the investigation by the Subcommittee on Drug Safety (held on June 16, 2009)>
 Sep 7, 2009 (Full text)
June 24, 2009 258
  1. Selective serotonin reuptake inhibitors (SSRIs) and aggression
  2. Important Safety Information

    (1)Isoflurane

  3. Revision of PRECAUTIONS (No. 206)
    Olmesartan medoxomil (and 3 others)
  4. List of products subject to Early Post-marketing Phase Vigilance
<Reference>
  1. Project for promoting safe use of drugs
  2. Manuals for Management of Individual Serious Adverse Drug Reactions
  3. Extension of cooperating hospitals in the project for "Japan Drug Information Institute in Pregnancy"
 July 31, 2009 (Full text)
May 28, 2009 257
  1. Implementation of appropriate management / maintenance of automated external defibrillators (AEDs)
  2. Revision of PRECAUTIONS (No. 205)
    Naproxen (and 7 others)
  3. List of products subject to Early Post-marketing Phase Vigilance
 July 14, 2009 (Full text)