MHLW Pharmaceuticals and Medical Devices Safety Information (FY2010)

1. Revision of Package Insert of Inferior Vena Cava Filter
2. Promotion of Safety Measures Using the PMDA medi-navi
3. Important Safety Information

   (1)Isosorbide

   (2)Unseiin

4. Revision of Precautions (No. 224)
   Gorinsan (and 17 others)
5. List of Products Subject to Early Post-marketing Phase Vigilance

1. Safety Measures for Gemtuzumab Ozogamicin (Genetical Recombination)
2. Important Safety Information

   (1)Imatinib Mesilate, Nilotinib Hydrochloride Hydrate

   (2Sunitinib Malate

   (3)Pilsicainide Hydrochloride Hydrate

3. Revision of Precautions (No. 223)
   Ciclosporin (oral and injectable dosage forms) (and 13 others)
4. List of Products Subject to Early Post-marketing Phase Vigilance

1. Safety Measures Against Photosensitivity Due to Topical Ketoprofen
2. Research on System for Receiving Adverse Reaction Information from Patients
3. Revision of Precautions (No. 222)

   (1)Atomoxetine Hydrochloride (and 10 others)

   (2)Inferior Vena Cava Filter

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

1. Safety Measures for Use of the Antidiabetic Drugs with New Action Mechanisms
   (DPP-4 inhibitors and GLP-1 receptor agonists)
2. Important Safety Information

   (1)Keigairengyoto, Nijutsuto

   (2)Ryutanshakanto

3. Revision of Precautions (No. 221)
   Aliskiren Fumarate (and 8 others)
4. List of Products Subject to Early Post-marketing Phase Vigilance

1. Important Safety Information

   (1)Adalimumab (Genetical Recombination)

   (2)Erlotinib Hydrochloride

   (3)Gefitinib

   (4)Goserelin Acetate

   (5)Solifenacin Succinate

   (6)Bicalutamide, Flutamide

   (7)Pemetrexed Sodium Hydrate

   (8)Leuprorelin Acetate

2. Revision of Precautions (No. 220)
   Alglucosidase Alfa (Genetical Recombination) (and 22 others)
3. List of Products Subject to Early Post-marketing Phase Vigilance

1. The Relief System for Sufferers from Adverse Drug Reactions and Diseases Infected from Biological Products
2. Summary of the Report on Adverse Reactions Associated with the Influenza A (H1N1) Vaccines in the 2009 Season
3. Important Safety Information

   (1)Influenza HA Vaccine, Influenza A (H1N1) HA Vaccine, Influenza A (H1N1) HA Emulsion Vaccine, Cell-culture Derived Influenza A (H1N1) Emulsion HA Vaccine

   (2)Thalidomide

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

Reports on adverse reactions associated with seasonal influenza vaccines in FY 2009 (Conclusion of the Vaccine Adverse Reaction Review Committee)

1. Safety Measures Against Bisphosphonate-related Osteonecrosis and Osteomyelitis of Jaw: Review Process and Implementation
2. Revision of Precautions (No. 219)
   Amitriptyline Hydrochloride (and 16 others)
3. List of Products Subject to Early Post-marketing Phase Vigilance

1. Precautions in Handling of Bipolar Electrode Used along with Electrosurgical Device
2. Important Safety Information

   (1)Olmesartan Medoxomil, Olmesartan Medoxomil / Azelnidipine, Telmisartan, Telmisartan / Hydrochlorothiazide, Valsartan, Valsartan / Amlodipine Besilate, Valsartan / Hydrochlorothiazide

   (2)Yokukansan

3. Revision of Precautions (No. 218)
   Phenytoin (and 5 others)
4. List of Products Subject to Early Post-marketing Phase Vigilance

1. Association between the use of TNF blockers and malignancies
2. Important Safety Information

   (1)Deferasirox

   (2)Furosemide

3. Revision of PRECAUTIONS (No. 217)
   Oxytocin (and 21 others)
4. List of products subject to Early Post-marketing Phase Vigilance

Project to survey provision and availability of information on appropriate use of drugs

1. Project to Collect and Analyze Medical "Near-Miss" Incidents from Pharmacies
2. Important Safety Information

   (1)Clopidogrel Sulfate

   (2)Sitagliptin Phosphate Hydrate, Vildagliptin, Liraglutide (Genetical Recombination), Alogliptin Benzoate

   (3)Tacrolimus Hydrate (oral dosage form, injectable dosage form)

3. Revision of PRECAUTIONS (No. 216)
   Infliximab (Genetical Recombination) (and 15 others)
4. List of Products Subject to Early Post-marketing Phase Vigilance

1. Manuals for Management of Individual Serious Adverse Drug Reactions
2. Project of Japan Drug Information Institute in Pregnancy
3. Important Safety Information

   (1)Atorvastatin Calcium Hydrate, Simbastatin, Pitavastatin Calcium, Pravastatin Sodium, Fluvastatin Sodium, Rosuvastatin Calcium, Amlodipine Besilate / Atorvastatin Calcium Hydrate

   (2)Cetuximab (Genetical Recombination)

4. Revision of PRECAUTIONS (No. 215)
   Aripiprazole (and 6 others)
5. List of products subject to Early Post-marketing Phase Vigilance