PMDA Risk Communications

Drug risk information of ongoing evaluation

This webpage provides drug risk information which has come under review by the PMDA and 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.