Japan PMDA Safety (EN)

Ongoing Drug Safety Evaluations, Risk Information

PMDA and MHLW publish ongoing drug safety evaluations for drugs marketed in Japan, including HPV vaccines (bivalent and quadrivalent) and Bevacizumab (genetical recombination). The page summarises two evaluation categories: risk information supported by accumulated ADR reports or EPPV data, and risk information flagged by foreign regulatory agencies or published studies where PMDA and MHLW have commenced review. Completed evaluations are moved to the Revisions of PRECAUTIONS webpage, and patients are advised not to discontinue treatment without consulting a physician.

Dear Healthcare Professional Letters - Emergent and Rapid Drug Safety Communications

PMDA maintains an index of Dear Healthcare Professional Letters (DHPCs) communicating drug safety information to medical institutions in Japan. The letters are categorized as Yellow Letters (emergent and important safety information requiring immediate communication) and Blue Letters (prompt but non-emergent safety information). The index lists nine DHPCs issued between August 2011 and June 2021, covering drugs including Verzenio (abemaciclib), Lamictal (lamotrigine), Xeplion (paliperidone), and others, each with associated case reports. Marketing authorization holders are required under Article 68-10 of the Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices to take necessary measures including recall, suspension of sales, and information provision when drugs may cause public health hazards.

Japan PMDA Drug Safety Alerts, 16 Alerts Listed

PMDA publishes a reference index of 16 drug safety alerts for healthcare professionals, covering drug classes including COVID-19 treatments (Xocova, Lagevrio), DPP-4 inhibitors, benzodiazepine receptor agonists, and drugs such as lamotrigine, thiamazole, and benzbromarone. Alerts range from Alert No. 1 (August 2010) through Alert No. 16 (December 2024), with several marked as revised. The English version is noted as a convenience translation with the Japanese original prevailing in case of inconsistency.