We post safety information on pharmaceuticals and medical devices issued by the Ministry of Health, Labor and Welfare.

DSU (Drug Safety Information)

December 2020 DSU (Drug Safety Information) No.313 (link to an external site) has been released.
Details and past information can be found from the link below.

DSU (Drug Safety Information) (link to an external site)

(Incorporated administrative agency Pharmaceuticals and Medical Devices Agency homepage)

Safety information for pharmaceuticals and medical devices

On November 9, 2020, Drugs and Medical Devices Safety Information No. 396 (link to an external site) has been released.

Safety information for pharmaceuticals and medical devices (link to an external site)

(Ministry of Health, Labor and Welfare website)

OTC version of DSU (OTC drug Precautions Revision Information)

November 2022, No. 10 Loxoprofen sodium hydrate-containing preparation (oral dosage form) (link to an external site) has been released.
Details and past information can be found from the link below.

OTC version DSU (OTC drug usage precautions revision information) (link to an external site) (opens in a separate window)

(Incorporated administrative agency Pharmaceuticals and Medical Devices Agency homepage)

Pharmacy Hiyari Hatto Case Collection and Analysis Project

September 30, 2020 The 27th tabulation report of the pharmacy near miss case collection and analysis project (link to an external site) has been released.
September 30, 2020 The 2021 Annual Report of the Pharmacy Hiyari Hatto Case Collection and Analysis Project (opens in a new window) has been released.
Details and past information can be viewed from the link below.

Pharmacy close call example collection, analysis business (we link to the outside site) (open with the other window)

(Japan Council for Quality Health Care website)

Generic drug quality information

September 2020 Generic drug quality information No. 15 (link to an external site) has been released.
You can see the details from the link below.

Generic drug quality information (link to an external site) (opens in a new window)

Emergency Safety Information (Yellow Letter) / Safety Bulletin (Blue Letter)

On June 1, 2021, safety information (blue letter) regarding shock and anaphylaxis due to Joycle Joint Injection 30 mg (link to an external site) was issued.
You can see the details from the link below.

Emergency Safety Information (Yellow Letter) / Safety Bulletin (Blue Letter) (link to external site) (opens in a new window)

(Incorporated administrative agency Pharmaceuticals and Medical Devices Agency homepage)

Information on publicly known application items covered by insurance

• About information about public knowledge application product covered by insurance (link to the outside site)
  (Incorporated administrative agency Pharmaceuticals and Medical Devices Agency website)
• About insurance coverage of off-label drugs for which prior evaluation related to publicly known application has been completed (link to an external site) (opens in a separate window)
  (Ministry of Health, Labor and Welfare website)

Request for proper use of medical devices from PMDA

July 2017 Adverse events due to the use of aortic stent grafts (link to an external site) (opens in a new window) has been published.
Details and past information can be viewed from the link below.

Request for Proper Use of Medical Devices from PMDA (link to external site) (opens in a new window)

(Incorporated administrative agency Pharmaceuticals and Medical Devices Agency homepage)

Related information

• Safety information, recall information, package inserts, etc. (Pharmaceuticals and Medical Devices Agency) (link to an external site) (opens in a new window)
• Collection related information (Ministry of Health, Labor and Welfare homepage) such as pharmaceuticals (link to the outside site) (open with the other window)
• About medical safety measures (Ministry of Health, Labor and Welfare homepage) (link to the outside site) (open with the other window)
• Japan Council for Quality Health Care (link to an external site) (opens in a new window)