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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:
- 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. - 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.
| Posted Date | Nonproprietary Name | Risk Information Ongoing Evaluation | Related Information | Investigation Results |
|---|---|---|---|---|
| March 6, 2020 | Baloxavir marboxil | Colitis ischaemic | - | - |
| Amenamevir | Toxic epidermal necrolysis Oculomucocutaneous syndrome Erythema multiforme |
- | ||
| Aciclovir (oral and injectable dosage forms) Valaciclovir hydrochloride |
Tubulointerstitial nephritis | - | ||
| Pembrolizumab (genetical recombination) | Toxic epidermal necrolysis | - | ||
| January 31, 2020 | Pegfilgrastim (genetical recombination) Filgrastim (genetical recombination) Filgrastim (genetical recombination, follow-on biologic 1) Filgrastim (genetical recombination, follow-on biologic 2) Filgrastim (genetical recombination, follow-on biologic 3) Lenograstim (genetical recombination) Nartograstim (genetical recombination) |
Thrombocytopenia | - | - |
| December 13, 2019 | Spiperone Sultopride hydrochloride Sulpiride Timiperone Nemonapride Haloperidol Haloperidol decanoate Pipamperone hydrochloride Pimozide Fluphenazine decanoate Blonanserin Bromperidol Perospirone hydrochloride hydrate Mosapramine hydrochloride Aclatonium napadisilate |
Precautions for patients with dementia with Lewy bodies | - | - |
| 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 |