Drug Risk Information of Ongoing Evaluation Updated

Drug Risk Information of Ongoing Evaluation Updated

(PDF Download this page for PDF version (PDF))

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 (Japanese text only))
Risk Information Ongoing Evaluation Related Information Evaluation Result
(Japanese Text Only)
Updated
September 25, 2012

August 31, 2012

Cibenzoline Succinate Hepatic dysfunction, Jaundice,
Anaphylactoid symptoms
Updated
Package insert revision
PDF (PDF)
Lithium Carbonate Brugada syndrome, Acute renal failure, Interstitial nephritis, Nephrotic syndrome, Hipothyroidism, Thyroiditis, Hyperparathyroidism Updated
Package insert revision
PDF (PDF)
Telaprevir Agranulocytosis Updated
Package insert revision
PDF (PDF)
Levocabastine Hydrochloride Shock, Anaphylactoid symptoms Updated
Package insert revision
PDF (PDF) / PDF (PDF)
Diclofenac Sodium
(For external use except suppository and rectal ointment)
(For ethical use)
Shock, Anaphylactoid symptoms Updated
Package insert revision
PDF (PDF) / PDF (PDF)
Diclofenac Sodium-containing products
(For OTC)
Shock (Anaphylaxis) Updated
Package insert revision
PDF (PDF)
Tocilizumab (Genetical Recombination) Reactivation of Hepatitis B virus Updated
Package insert revision
PDF (PDF)
Tetracosactide Acetate
(Intramuscular injection)
Infections Updated
Package insert revision
PDF (PDF)
Propylthiouracil Anaphylactoid symptoms Updated
Package insert revision
PDF (PDF)
Tegafur/ Gimeracil/ Oteracil Potassium Lacrimal duct obstruction, Nephrotic syndrome Updated
Package insert revision
PDF (PDF)
Aliskiren Fumarate Anaphylactoid symptoms Updated
Package insert revision
PDF (PDF)

 

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
(Click on each drug name for more information on Package inserts (Japanese text only))
Risk Information Ongoing Evaluation Related Information Evaluation Result
December 28, 2011 Aliskiren Fumarate  PDFMHLW/PMDA starts review of Rasilez (Aliskiren Fumarate)
Communication on combination therapy of Rasilez with an ACE inhibitor or ARB to hypertension patients with complication of diabetes (PDF)
 PDF EMA: European Medicines Agency starts review of aliskiren-containing medicines following termination of ALTITUDE study (PDF) Package insert revision
PDF (PDF)
November 30, 2011 Avastin (bevacizumab)  PDFJapan’s view on Avastin (bevacizumab) for breast cancer indication (PDF) Press Announcement from the FDA

PDFReview report of AVASTIN® 100mg/4mL Intravenous Infusion and AVASTIN® 400mg/16mL Intravenous Infusion on July 14, 2011 (Japanese text only) (PDF)

July 29, 2011

Updated version, dated 6 January 2012 (Additions are noted by underline)

Somatropin (genetical recombination)  PDF Update on Ongoing PMDA/MHLW Review the Safety of Somatoropin-containing Medicines (PDF) PDF For patients treated (are treating) with the recombinant growth hormone “regarding the Press release ‘European Medicines Agency to review the safety of somatoropin containing medicines’ ” (Japanese text only) (PDF)

PDF EMA: Update on somatropin-containing medicines (PDF)

FDA: FDA Drug Safety Communication: Ongoing safety review of Recombinant Human Growth Hormone (somatropin) and possible increased risk of death

July 25, 2011 Pioglitazone Hydrochloride PDFUpdated information about pioglitazone and increased risk of bladder cancer (PDF) PDFEMA: European Medicines Agency recommends new contra-indications and warnings for pioglitazone to reduce small increased risk of bladder cancer (PDF)

PDF Update on ongoing European review of pioglitazone-containing medicines (PDF)

FDA: FDA Drug Safety Communication: Update to ongoing safety review of Actos (pioglitazone) and increased risk of bladder cancer

Report of the investigation result (Japanese version only)
PDF http://www.info.pmda.go.jp/ riscommu/ PDF/ riscommu110803frep.pdf (PDF)

Please refer to the Japanese page of “Drug Risk Information of Ongoing Evaluation”

Drug Risk Information of Ongoing Evaluation Updated

(PDF Download this page for PDF version (PDF))

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 (Japanese text only))
Risk Information Ongoing Evaluation Related Information Evaluation Result
(Japanese Text Only)
Updated
September 25, 2012

August 31, 2012

Cibenzoline Succinate Hepatic dysfunction, Jaundice,
Anaphylactoid symptoms
Updated
Package insert revision
PDF (PDF)
Lithium Carbonate Brugada syndrome, Acute renal failure, Interstitial nephritis, Nephrotic syndrome, Hipothyroidism, Thyroiditis, Hyperparathyroidism Updated
Package insert revision
PDF (PDF)
Telaprevir Agranulocytosis Updated
Package insert revision
PDF (PDF)
Levocabastine Hydrochloride Shock, Anaphylactoid symptoms Updated
Package insert revision
PDF (PDF) / PDF (PDF)
Diclofenac Sodium
(For external use except suppository and rectal ointment)
(For ethical use)
Shock, Anaphylactoid symptoms Updated
Package insert revision
PDF (PDF) / PDF (PDF)
Diclofenac Sodium-containing products
(For OTC)
Shock (Anaphylaxis) Updated
Package insert revision
PDF (PDF)
Tocilizumab (Genetical Recombination) Reactivation of Hepatitis B virus Updated
Package insert revision
PDF (PDF)
Tetracosactide Acetate
(Intramuscular injection)
Infections Updated
Package insert revision
PDF (PDF)
Propylthiouracil Anaphylactoid symptoms Updated
Package insert revision
PDF (PDF)
Tegafur/ Gimeracil/ Oteracil Potassium Lacrimal duct obstruction, Nephrotic syndrome Updated
Package insert revision
PDF (PDF)
Aliskiren Fumarate Anaphylactoid symptoms Updated
Package insert revision
PDF (PDF)

 

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
(Click on each drug name for more information on Package inserts (Japanese text only))
Risk Information Ongoing Evaluation Related Information Evaluation Result
December 28, 2011 Aliskiren Fumarate  PDFMHLW/PMDA starts review of Rasilez (Aliskiren Fumarate)
Communication on combination therapy of Rasilez with an ACE inhibitor or ARB to hypertension patients with complication of diabetes (PDF)
 PDF EMA: European Medicines Agency starts review of aliskiren-containing medicines following termination of ALTITUDE study (PDF) Package insert revision
PDF (PDF)
November 30, 2011 Avastin (bevacizumab)  PDFJapan’s view on Avastin (bevacizumab) for breast cancer indication (PDF) Press Announcement from the FDA

PDFReview report of AVASTIN® 100mg/4mL Intravenous Infusion and AVASTIN® 400mg/16mL Intravenous Infusion on July 14, 2011 (Japanese text only) (PDF)

July 29, 2011

Updated version, dated 6 January 2012 (Additions are noted by underline)

Somatropin (genetical recombination)  PDF Update on Ongoing PMDA/MHLW Review the Safety of Somatoropin-containing Medicines (PDF) PDF For patients treated (are treating) with the recombinant growth hormone “regarding the Press release ‘European Medicines Agency to review the safety of somatoropin containing medicines’ ” (Japanese text only) (PDF)

PDF EMA: Update on somatropin-containing medicines (PDF)

FDA: FDA Drug Safety Communication: Ongoing safety review of Recombinant Human Growth Hormone (somatropin) and possible increased risk of death

July 25, 2011 Pioglitazone Hydrochloride PDFUpdated information about pioglitazone and increased risk of bladder cancer (PDF) PDFEMA: European Medicines Agency recommends new contra-indications and warnings for pioglitazone to reduce small increased risk of bladder cancer (PDF)

PDF Update on ongoing European review of pioglitazone-containing medicines (PDF)

FDA: FDA Drug Safety Communication: Update to ongoing safety review of Actos (pioglitazone) and increased risk of bladder cancer

Report of the investigation result (Japanese version only)
PDF http://www.info.pmda.go.jp/ riscommu/ PDF/ riscommu110803frep.pdf (PDF)

Please refer to the Japanese page of “Drug Risk Information of Ongoing Evaluation”

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