MHLW Pharmaceuticals and Medical Devices Safety Information (FY2023)

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

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

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

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

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

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

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

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

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)