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Pharmaceuticals and Medical Devices Agency (Japan) pmda.go.jp

[ANZEN]PMDA Risk Communications: Ibuprofen L-Lysine,etc. posted

Imported from official source

Announcement

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:

  • 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.
  • 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.
  • 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.​

    • This is an extract. The publication continues at the source.

    Read the original at the source: https://www.pmda.go.jp/english/safety/info-services/drugs/risk-communications/0001.html

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    Provenance

    Organization
    Pharmaceuticals and Medical Devices Agency (Japan) — imported from official source
    Official source
    https://www.pmda.go.jp/rss_008.xml RSS
    Imported
    October 03, 2026 20:39
    Versions
    1 recorded
    Identity
    https://www.pmda.go.jp/english/safety/info-services/drugs/risk-communications/0001.html

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