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Post-marketing Safety Measures

MHLW Pharmaceuticals and Medical Devices Safety Information (FY2023)

FY 2023 (No.400-)

Japanese version issued on No. Table of contents Posted on PDF
March 14,
2024
408
  1. Preparation of Materials for Information Provision in Cooperation With the Patients’ Associations (Activities by the PMDA)
  2. Revision of PRECAUTIONS for Topiramate
  3. Revision of PRECAUTIONS (No.348)
    Adsorbed diphtheria-purified pertussis-tetanus-inactivated polio-Haemophilus type b conjugate combined vaccine (and 5 others)
  4. List of Products Subject to
    Early Post-marketing Phase Vigilance
March 14, 2024 (Full text)
February 7,
2024
407
  1. Suspected Adverse Reactions to Influenza Vaccines in the 2022 Season
  2. The Manuals for Management of Individual Serious Adverse Drug Reactions
  3. Important Safety Information
    1. [1] Acetazolamide, [2] Acetazolamide sodium
    2. •Dexamethasone preparations ([1] Dexamethasone (oral dosage form) and 2 others)
      •Prednisolone preparations ([1] Prednisolone (oral dosage form) and 2 others)
      •Methylprednisolone preparations ([1]
      Methylprednisolone and 2 others)
      •Cortisone/Hydrocortisone preparations ([1] Cortisone acetate and 4 others)
    3. Atezolizumab (genetical recombination)
    4. [1] Encorafenib, [2] Binimetinib
    5. Pembrolizumab (genetical recombination)
  4. Revision of PRECAUTIONS (No.347)
    Sertraline hydrochloride (and 11 others)
  5. List of Products Subject toEarly Post-marketing Phase Vigilance
February 7, 2024 (Full text)
December 19, 2023 406
  1. Revisions of PRECAUTIONS for Oral Anticoagulants (Acute Kidney Injury)​
  2. Proper Use of GLP-1 Receptor Agonists and GIP/GLP-1 Receptor Agonists
  3. Important Safety Information
    1. Metyrapone
    2. [1] Apixaban, [2] Edoxaban tosilate hydrate, [3] Dabigatran etexilate methanesulfonate, [4] Rivaroxaban, [5] Warfarin potassium
    3. Technetium (99mTc) galactosyl human serum albumin diethylenetriamine pentaacetic acid
  4. Revision of PRECAUTIONS  (No. 346)
    Metyrapone (and 4 others)
  5. List of Products Subject to Early Post-marketing Phase Vigilance
December 19, 2023 (Full text)
November 9,
2023
405
  1. Summary of the Relief System for Adverse Drug Reactions and Request for Cooperation With the System
  2. Revisions of PRECAUTIONS for Preparations Containing Acetaminophen (Prescription Drugs)
  3. Important Safety Information
    1. Apalutamide
    2. Technetium (99mTc) tetrofosmin
  4. Revision of PRECAUTIONS  (No. 345)
    Filgrastim (genetical recombination) (and 14 others)
  5. List of Products Subject to Early Post-marketing Phase Vigilance
Nov 9, 2023 (Full text)
September 27,
2023
404
  1. Fire Accidents During Home Oxygen Therapy
  2. Amendment of the Guidance for Provision of Dear Healthcare Professional Letters of Emergent/Rapid Safety Communications
  3. Important Safety Information
    1. Dabigatran etexilate methanesulfonate
    2. Rivastigmine
    3. Peficitinib hydrobromide
  4. Revision of PRECAUTIONS  (No. 344)
    Rivastigmine (and 5 others)
  5. List of Products Subject to Early Post-marketing Phase Vigilance
Sep 27, 2023 (Full text)
August 23,
2023
403
  1. Safety Measures Against the Risks of Contamination with Nitrosamines in Drugs
  2. Important Safety Information
    1. [1] Atorvastatin calcium hydrate, [2] Simvastatin, [3] Pitavastatin calcium hydrate, [4] Pravastatin sodium, [5] Fluvastatin sodium, [6] Rosuvastatin calcium, [7] Amlodipine besilate/
      atorvastatin calcium hydrate, [8] Ezetimibe/atorvastatin calcium hydrate, [9] Ezetimibe/rosuvastatin calcium, [10] Pitavastatin calcium hydrate/ezetimibe
  3. Revision of PRECAUTIONS  (No. 343)
    [1] Atorvastatin calcium hydrate (and 9 others), and 3 others
  4. List of Products Subject to Early Post-marketing Phase Vigilance
Aug 23, 2023 (Full text)
July 11,
2023
402
  1. The Manuals for Management of Individual Serious Adverse Drug Reactions
  2. Reports from Healthcare Professionals on Adverse Drug Reactions/Infections/ Malfunctions and Post-vaccination Suspected Adverse Reactions Are to Be Sent to the PMDA Online [Report Reception Site]
  3. Important Safety Information
    1. [1] Nivolumab (genetical recombination)
      [2] Ipilimumab (genetical recombination)
  4. Revision of PRECAUTIONS (No. 342)
    Haemophilus influenzae type b conjugate vaccine (tetanus toxoid conjugate) (and 2 others) 
  5. List of Products Subject to Early Post-marketing Phase Vigilance
Jul 11, 2023 (Full text)
May 18,
2023
401
  1. Revision of Precautions for Drugs Inhibiting the Renin-angiotensin System
  2. The Survey Results on the Status of Acquisition, Communication, and Use of Drug Safety Information at Hospitals and Pharmacies and Desirable Directions
  3. Important Safety Information
    1. ・Angiotensin-converting enzyme inhibitors ([1] Alacepril and 9 others)
      ・Preparations containing angiotensin II receptor blocker([1] Azilsartan and 19 others)
      ・Direct renin inhibitor ([1] Aliskiren fumarate)
    2. ・Angiotensin receptor-neprilysin inhibitor
      ([1] Sacubitril valsartan sodium hydrate)
    3. Mesalazine
    4. Zinc acetate hydrate
  4. Revision of Precautions  (No. 341)
    [1] Azilsartan (and 30 others) and 7 others
  5. List of Products Subject to Early Post-marketing Phase Vigilance
May 30, 2023 (Full text)
April 20,
2023
400
  1. Revision of Drugs That May Cause Abuse, Etc.
  2. Revision of Precautions for Antitubercular Agents
  3. Important Safety Information
    1. Borofalan (10B)
  4. Revision of Precautions  (No. 340)
    Borofalan (10B) (and 6 others)
  5. List of Products Subject to Early Post-marketing Phase Vigilance

(Reference)
Terminology of “Phaeochromocytoma” in the Precautions of Drugs (Excluding in vitro Diagnostics)

Apr 20, 2023 (Full text)