MHLW Pharmaceuticals and Medical Devices Safety Information (FY2016)

1. Revisions of Proper Control Procedures for Revlimid/Pomalyst (RevMate)
2. Research on Actual Status in Drugs and Medical Devices Safety Information Reporting System
3. Revision of Precautions (No. 282)
   Hydroxyzine hydrochloride, Hydroxyzine pamoate and the others

4. List of Products Subject to
   Early Post-marketing Phase Vigilance

Terminology of "Acute Kidney Injury"

1. Precautions Concerning Recurrent and Similar Medical Accidents
2. Revision of Precautions (No. 281)
   Iguratimod (and 2 others)
3. List of Products Subject to Early Post-marketing Phase Vigilance

Precautions Regarding Handling of Fire During Long-Term Oxygen Therapy (LOT)

1. Precautions for Driving, etc. under the Treatment with Milnacipran Hydrochloride, Duloxetine Hydrochloride, or Venlafaxine Hydrochloride
2. Suspected Adverse Reactions to Influenza Vaccines in the 2015 Season
3. Safety of Influenza Antiviral Drugs
4. Important Safety Information

(1) Polaprezinc
(2) Allopurinol
(3) Alogliptin benzoate, Linagliptin, Teneligliptin hydrobromide hydrate

5. Revision of Precautions (No. 280)

Formalin (and 4 others)

6. List of Products Subject to
   Early Post-marketing Phase Vigilance

1. Interactions in Co-administration of Miconazole and Warfarin Potassium
2. Safety Measures against Bladder Cancer Associated with Diabetes Medication "Pioglitazone Hydrochloride-Containing Products"
3. Project of the Japan Drug Information Institute in Pregnancy
4. Important Safety Information

(1) Atorvastatin calcium hydrate (and 6 other HMG-CoA reductase inhibitors)
(2) Ustekinumab (genetical recombination)
(3) Nivolumab (genetical recombination)

5. Revision of Precautions (No. 279)

Warfarin potassium (and 4 others)

6. List of Products Subject to
   Early Post-marketing Phase Vigilance

1. Summary of the Relief System for Adverse Drug Reaction and Request of Cooperation for the System
2. Amendment of Procedures for Bar Code Labeling on Prescription Drugs
3. Important Safety Information

(1) Imatinib Mesilate (and 3 other tyrosine-kinases inhibitors)
(2) Afatinib Maleate
(3) Corticorelin (human)

4. Revision of Precautions (No. 278)

Natalizumab (genetical recombination) (and 3 others)

5. List of Products Subject to
   Early Post-marketing Phase Vigilance

1. Precautions Relating to Interstitial Lung Disease During Administration of Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitors
2. Genome Research Relating to Drug-induced Serious Skin Disorders
3. Important Safety Information

(1) Olanzapine
(2) Azosemide

4. Revision of Precautions (No. 277)

Imatinib mesilate (and 4 others)

5. List of Products Subject to
   Early Post-marketing Phase Vigilance

1. Precautions Relating to the Teratogenicity of Mycophenolate Mofetil Preparations
2. Important Safety Information

(1) Nintedanib Ethanesulfonate
(2) Ombitasvir Hydrate/Paritaprevir Hydrate/Ritonavir
(3) Sofosbuvir, Ribavirin
(4) Ledipasvir Acetonate/Sofosbuvir

3. Revision of Precautions (No. 276)

Diclofenac Sodium (and 6 others)

4. List of Products Subject to
   Early Post-marketing Phase Vigilance

1. Risk Management Plans (RMPs) Outline Sheets
2. Surveillance on Access to, Dissemination, and Utilization of Drug Safety Information in Clinics and Pharmacies
3. Important Safety Information

(1) Telaprevir, Simeprevir Sodium, Daclatasvir Hydrochloride, Asunaprevir, Vaniprevir, Sofosbuvir, Ledipasvir Acetone Adduct/Sofosbuvir, Ombitasvir Hydrate/Paritaprevir Hydrate/Ritonavir
(2) Levetiracetam

4. Revision of Precautions (No. 275)

Alendronate sodium hydrate,
Ibandronate Sodium Hydrate,
Etidronate Disodium,
Zoledronic Acid Hydrate,
Pamidronate Disodium Hydrate,
Minodronic Acid Hydrate,
Risedronate Sodium Hydrate

5. List of Products Subject to
   Early Post-marketing Phase Vigilance

1. Use of "PMDA Medi-navi" and "My Drug List for Safety Updates"
2. Precautions Concerning Recurrent and Similar Incidents of Medical Accidents
3. Important Safety Information

(1) Sodium chloride,etc.combination products
(2) Vildagliptin and 2 others
(3) Pseudoephedrine hydrochloride combination product
(4) Peramivir hydrate
(5) Levodopa and 3 others

4. Revision of Precautions (No. 274)

Gabapentin (and 7 others)

5. List of Products Subject to Early Post-marketing Phase Vigilance (as of April 2016)

1. Notification Regarding Fulminant Type 1 Diabetes Mellitus During Use of Nivolumab (Genetical Recombination)
2. Change in Report Forms for "Drugs and Medical Devices Safety Information Reporting System"
3. Important Safety Information

(1) Furosemide

4. Revision of Precautions (No. 273)

Flunitrazepam (Injections) (and 7 others)

5. List of Products Subject to Early Post-marketing Phase Vigilance (as of March 2016)