MHLW Pharmaceuticals and Medical Devices Safety Information (FY2023)

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)