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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.
  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.
  1. Risk Information which some safety measures might be taken.
Posted Date Nonproprietary Name
(Click on each drug name for more information on Package inserts)
(only available in Japanese language)
Risk Information Ongoing Evaluation Related Information Investigation Results
June 9, 2017 Hydroxocobalamin Acute kidney injury - Coming soon
Fluconazole
Fluconazole
Fluconazole
Fluconazole
Fluconazole
Fosfluconazole
Drug-induced hypersensitivity syndrome (DIHS) -
Patch test products containing gold (I) sodium thiosulfate Precautions against reaction to gold (I) sodium thiosulfate -
Loxoprofen sodium hydrate(Cataplasms/Gel Patches)
Loxoprofen sodium hydrate(Tape)
Loxoprofen sodium hydrate(Gel)
Loxoprofen sodium hydrate(Spray)
Shock, Anaphylaxis -
Loxoprofen sodium hydrate
(dermatologic preparation)
(guidance-mandatory drugs)
Shock, Anaphylaxis -
Nivolumab
(genetical recombination)
Sclerosing cholangitis -
Codeine phosphate hydrate
Codeine phosphate hydrate
Codeine phosphate hydrate
Codeine phosphate hydrate
Codeine phosphate hydrate

Dihydrocodeine phosphate
Dihydrocodeine phosphate
Dihydrocodeine phosphate

Codeine phosphate hydrate/cherry bark extract

Dihydrocodeine phosphate/
dl-methylephedrine hydrochloride/
chlorpheniramine maleate

Dihydrocodeine phosphate/
dl-methylephedrine hydrochloride/
chlorpheniramine maleate

Dihydrocodeine phosphate/
dl-methylephedrine hydrochloride/
chlorpheniramine maleate


Dihydrocodeine phosphate/diprophylline/dl-methylephedrine hydrochloride/diphenhydramine salicylate/acetaminophen/bromovalerylurea

Dihydrocodeine phosphate/platycodon fluidextract/glycyrrhiza extract/plantago extract/peony root extract

Dihydrocodeine phosphate/ephedrine hydrochloride/ammonium chloride

Products containing codeine phosphate hydrate or dihydrocodeine phosphate (OTC)
Precautions against respiratory depression -
Tramadol hydrochloride
Tramadol hydrochloride
Tramadol hydrochloride
Tramadol hydrochloride/acetaminophen
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
 
  1. 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
(Click on each drug name for more information on Package inserts)
(only available in Japanese language)
Risk Information Ongoing Evaluation Related Information Investigation Results
(only available in Japanese language)
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)(1)

Somatropin (genetical recombination)(2)

Somatropin (genetical recombination)(3)

Somatropin (genetical recombination)(4)

Somatropin (genetical recombination)(5)

Somatropin (genetical recombination)(6)

Somatropin (genetical recombination)(7)

Somatropin (genetical recombination)(8)

Somatropin (genetical recombination)(9)

Somatropin (genetical recombination)(10)

Somatropin (genetical recombination)(11)

Somatropin (genetical recombination)(12)
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
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JCN 3010005007409

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