Japan: Pharmaceuticals and Medical Devices Agency (PMDA)

Visit agency website

Summary of Disproportionality Analysis Using VigiBase – Aug 29, 2023. PDF

The results of the disproportionality analysis using VigiBase suggested a relationship between finasteride and suicide-related events.

Summary of Investigation Results: Finasteride – Aug 29, 2023. PDF

Summary of revisions

1. Precautions concerning suicide-related events should be added to the IMPORTANT
PRECAUTIONS section.

2. “Patients with depression, depressed state, or a history of those diseases or patients
with a history of suicidal ideation or a suicide attempt” should be added to the
PRECAUTIONS CONCERNING PATIENTS WITH SPECIFIC BACKGROUNDS section
(new instructions) or the Careful Administration section (old instructions).

Review reports: Drugs. Zagallo – Sep 2015. Index (see Zagallo) • PDF in English • PDF in Japanese