PMDA Risk Communications

Drug Risk Information of Ongoing Evaluation

This webpage was developed to provide drug risk information which has come under review by the PMDA/MHLW. Information provided here is as follows:

1. Risk Information was suggested by a certain amount of accumulated information on Adverse Drug Reactions (ADR) reports or Early Postmarketing Phase Vigilance (EPPV). Certain safety measures such as revision of Precautions section in the labeling 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 results of evaluation in the “Revisions of Precaution” web page.
2. Risk Information which has attracted attention in foreign drug regulatory agencies or academic societies and PMDA/MHLW has started its evaluation. Information provided here is still under review. If you are taking the following medicines, you should NOT stop taking them or reduce the dosage only on your own judgment. Consult your healthcare professional if you have any questions or concerns about these medications.

2. Risk Information which has attracted attention in foreign drug regulatory agencies or academic societies and PMDA/MHLW has started its evaluation.

Posted Date	Nonproprietary Name	Risk Information Ongoing Evaluation	Related Information	Investigation Results
November 30, 2011	Bevacizumab (genetical recombination)	Japan's view on Avastin (bevacizumab) for breast cancer indication	Press Announcement from the FDA Review report of AVASTIN 100mg/4mL Intravenous Infusion and AVASTIN 400mg/16mL Intravenous Infusion on July 14, 2011 (Japanese text only)	-
July 29, 2011 Updated version, dated 6 January 2012 (Additions are noted by underline)	Somatropin (genetical recombination)	Update on Ongoing PMDA/MHLW Review of the Safety of Somatoropin-containing Medicines	"Regarding the Press release 'European Medicines Agency to review the safety of somatoropin containing medicines' " (Japanese text only) EMA: Update on somatropin-containing medicines FDA: FDA Drug Safety Communication: Ongoing safety review of Recombinant Human Growth Hormone (somatropin) and possible increased risk of death