MHLW Pharmaceuticals and Medical Devices Safety Information (FY2017)

1. Medical Information Database MID-NET (Medical Information Database NETwork)
2. Important Safety Information

(1) Gardenia fruit

3. Revision of Precautions (No. 292)

Gardenia fruit (and 6 others)

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

1. An Incident of Distribution of Counterfeit HARVONI Combination Tablets and Government Measures Against Counterfeit Drugs
2. Important Safety Information

(1)[1] Teriparatide (genetical recombination), [2] Teriparatide acetate (subcutaneous injection)
(2) Edoxaban tosilate hydrate
(3) Lenvatinib mesilate

3. Revision of Precautions (No. 291)

(1) Aripiprazole
(2) Aripiprazole hydrate (and 5 others)

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

1. Safety of Influenza Antiviral Drugs
2. Suspected Adverse Reactions to Influenza Vaccines in the 2016 Season
3. Important Safety Information

(1) Clozapine

4. Revision of Precautions (No. 290)

Clozapine (and 2 others)

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

1. Initiative of Revision of the Manuals for Management of Individual Serious Adverse Drug Reactions
2. Prevention of Accidents with Electric Massagers for Household Use
3. Important Safety Information

(1) Levetiracetam
(2) Linagliptin

4. Revision of Precautions (No. 289)

Levetiracetam (and 8 others)

5. 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. Important Safety Information

(1) Dabigatran etexilate methanesulfonate

3. Revision of Precautions (No. 288)

Dabigatran etexilate methanesulfonate
(and 2 others)

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

1. The Expert Committee on Quality of Generic Drug Products
2. Introduction of the “My Drug List for Safety Updates” service

3. Revision of Precautions (No. 287)

Riociguat (and 4 others)

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

1. Summary of Guidance for Adverse Drug Reaction Reporting by Medical and Pharmaceutical Providers
2. Important Safety Information

(1) Loxoprofen sodium hydrate (dermatologic preparation)
(2) Fluconazole, Fosfluconazole
(3) Nivolumab (genetical recombination)

3. Revision of Precautions (No. 286)

Loxoprofen sodium hydrate
(dermatologic preparation)(and 16 others)

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

1. Revision of Instructions for Package Inserts of Prescription Drugs
2. Precautions Concerning Recurrent and Similar Medical Accidents
3. Important Safety Information

(1) Treprostinil
(2) Bosutinib

4. Revision of Precautions (No. 285)

Treprostinil (and 3 others)

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

1. Project of the Japan Drug Information Institute in Pregnancy

2. Revision of Precautions (No. 284)

Denosumab (and 2 others)

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

1. Precautions for Dependence Associated with Hypnotics-Sedatives, Anxiolytics, and Antiepileptics
2. Optimal Clinical Use Guidelines
3. Important Safety Information

(1) Aluminum potassium sulfate hydrate/Tannic acid

4. Revision of Precautions (No. 283)

Lamotrigine (and 37 others)

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