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Post-marketing Safety Measures

PMDA Risk Communications (drug risk information of ongoing evaluation)

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This webpage provides drug risk information which has come under review by the PMDA and the Ministry of Health, Labour and Welfare (MHLW). Information provided here is as follows:

  1. Risk information suggested by a certain amount of accumulated information of adverse drug reactions (ADR) reports or Early Post-marketing Phase Vigilance (EPPV)
    Safety measures such as revision of PRECAUTIONS in the package insert of the product might be taken after the ongoing review.
    When evaluations are completed, the information in the table below will be deleted. You will find the results of evaluation on the “Revisions of PRECAUTIONS” webpage.
  2. Risk information which has attracted the attention of foreign regulatory agencies or academic societies based on studies published in scientific journals, etc., for which the PMDA and MHLW have started their evaluation since the risk information is related to drugs marketed in Japan
    Information provided here is still under review. If you are taking the following drugs, you should NOT stop taking them or reduce the dosage without consulting a physician. Consult your healthcare professionals if you have any questions or concerns about these drugs.

 

  1. Risk informationnote) for which some safety measures might be taken

​Note) This English version of risk information is intended to be a reference material to provide convenience for users. In the event of inconsistency between the Japanese original and this English translation, the former shall prevail. The PMDA shall not be responsible for any consequences resulting from the use of this English version.
Posted Date Nonproprietary Name Risk Information of Ongoing Evaluation Related Information Investigation Results
January
6, 2025		 Edoxaban tosilate hydrate Thrombocytopenia － －
Diclofenac etalhyaluronate sodium Safety measures regarding anaphylaxis － －
Pembrolizumab (genetical recombination) Pancreatic exocrine insufficiency － －
October 18, 2024 Following injectable preparations containing arginine:
  Ethical combination drugs containing arginine
  L-lysine hydrochloride/
L-arginine hydrochloride
  L-arginine L-glutamate hydrate
  L-arginine hydrochloride		 Anaphylaxis － －
Dulaglutide (genetical recombination) Hepatic impairment － －
December 26,
2013		 Recombinant absorbed bivalent human papillomavirus-like particle vaccine

Recombinant adsorbed quadrivalent human papillomavirus virus-like particle vaccine		 Symptoms related to pain － Summary of
the Report on the Surveillance Results of HPV Vaccines [40.4 KB]

 

  1. Risk information which has attracted the attention of foreign regulatory agencies or academic societies, for which the PMDA and MHLW have started their evaluation
Posted Date Nonproprietary Name Risk Information of Ongoing Evaluation Related Information Investigation Results
November 30,
2011		 Bevacizumab (genetical recombination) Japan's view on Avastin (bevacizumab) for breast cancer indication [54.3 KB] Press Announcement from the FDA

Review report of AVASTIN 100mg/4mL Intravenous Infusion and AVASTIN 400mg/16mL Intravenous Infusion on July 14, 2011 (only in Japanese) [1,708 KB]		 －