MHLW Pharmaceuticals and Medical Devices Safety Information (FY2011)

FY 2011 (No.279-289)

Japanese version issued on	No.	Table of contents	Posted on	PDF
March 28, 2012	289	Reactivation of Hepatitis B Virus Associated with Antineoplastic Agent Everolimus Use of the "PMDA medi-navi" and "My Drug List for Safety Update" Important Safety Information (1)Montelukast Sodium (2)Monobasic Sodium Phosphate Monohydrate / Dibasic Sodium Phosphate Anhydrous Revision of Precautions (No. 234) (1)Leflunomide (and 5 others) (2)Radiation Therapy Equipment List of Products Subject to Early Post-marketing Phase Vigilance (as of March 2012)	Apr 3, 2012	(Summary)
March 28, 2012	289		Apr 27, 2012	(Full text)
February 29, 2012	288	Systemic Allergy Associated with the Use of Quasi-drugs / Cosmetics Important Safety Information (1)Daikenchuto Revision of Precautions (No. 233) Galsulfase (Genetical Recombination) (and 13 others) List of Products Subject to Early Post-marketing Phase Vigilance (as of February 2012)	Mar 1, 2012	(Summary)
February 29, 2012	288		Mar 27, 2012	(Full text)
January 25, 2012	287	Lamotrigine-induced Severe Drug Eruption and Compliance with Dosage and Administration Fatal Accidents Involving Patients during Use of Long-term Oxygen Therapy List of Products Subject to Early Post-marketing Phase Vigilance (as of January 2012)	Jan 27, 2012	(Summary)
January 25, 2012	287		Feb 21, 2012	(Full text)
December 27, 2011	286	Cases of Non-payment under the Relief System for Sufferers from Adverse Drug Reactions and Proper Use of Drugs Important Safety Information (1)Epoprostenol Sodium Revision of Precautions (No. 232) Solifenacin Succinate (and 7 others) List of Products Subject to Early Post-marketing Phase Vigilance (as of December 2011)	Jan 6, 2012	(Summary)
December 27, 2011	286		Jan 25, 2012	(Full text)
November 30, 2011	285	Safety Measures against Nephrogenic Systemic Fibrosis associated with Gadolinium Contrast Media Carbamazepine-induced Serious Drug Eruption and Genetic Polymorphism Important Safety Information (1)Anastrozole (2)Temozolomide (3)Ritodrine hydrochloride (injectable dosage form) Revision of Precautions (No. 231) Atomoxetine Hydrochloride (and 6 others) List of Products Subject to Early Post-marketing Phase Vigilance	Dec 2, 2011	(Summary)
November 30, 2011	285		Dec 27, 2011	(Full text)
October 26, 2011	284	Safety Measures against Disturbed Consciousness Associated with the Use of Smoking Cessation Aid CHAMPIX Tablets The Guidelines for Provision of Dear Healthcare Professional Letters of Emergent / Rapid Safety Communications Summary of the Report on Adverse Reactions to the Influenza A (H1N1) Vaccine in the 2010 Season Important Safety Information (1)Voriconazole Revision of Precautions (No. 230) Gadoxetate Sodium (and 11 others) List of Products Subject to Early Post-marketing Phase Vigilance	Nov 1, 2011	(Summary)
October 26, 2011	284		Nov 29, 2011	(Full text)
September 28, 2011	283	Safety Measures against Bladder Cancer Associated with Diabetes Medication "Pioglitazone Hydrochloride-Containing Products" Important Safety Information (1)Influenza HA Vaccine (2)Thalidomide (3)Doxorubicin Hydrochloride (non-liposome preparation) (4)Dabigatran Etexilate Methanesulfonate Revision of Precautions (No. 229) Modafinil (and 16 others) List of Products Subject to Early Post-marketing Phase Vigilance	Oct 3, 2011	(Summary)
September 28, 2011	283		Oct 27, 2011	(Full text)
August 30, 2011	282	Revision of Contraindications for the Use of Coronary Stent Revision of Contraindications for the Use of Intraocular Lens Important Safety Information (1)Oxaliplatin (2)Recombinant Adsorbed Hepatitis B Vaccine (yeast-derived) (Bimmugen)) (3)Sunitinib Malate (4)Pneumococcal Polysaccharide Conjugate Vaccine (adsorbed) (5)Varenicline Tartrate (6)Lenalidomide Hydrate Revision of Precautions (No. 228) Pioglitazone Hydrochloride (and 8 others) List of Products Subject to Early Post-marketing Phase Vigilance	Sept 1, 2011	(Summary)
August 30, 2011	282		Sept 29, 2011	(Full text)
July 27, 2011	281	Revision of Package Inserts of Subcutaneous Port and Catheter Important Safety Information (1)Freeze-dried Live Attenuated Measles Vaccine; Freeze-dried Live Attenuated Measles, Rubella Combined Vaccine (2)Cisplatin (intra-arterial injection) (3)Sitagliptin Phosphate Hydrate (4)Sorafenib Tosilate (5)Metformin Hydrochloride (products with "Dosage and Administration" of maximum daily dosage of 2250mg) Revision of Precautions (No. 227) Cortisone Acetate (and 9 others) List of Products Subject to Early Post-marketing Phase Vigilance	August 4, 2011	(Summary)
July 27, 2011	281		August 30, 2011	(Full text)
June 29, 2011	280	Safety Measures for Pediatric Pneumococcal Conjugate Vaccine and Haemophilius Influenzae Type b (Hib) Vaccine Manuals for Management of Individual Serious Adverse Drug Reactions Important Safety Information (1)Olopatadine Hydrochloride (oral dosage form) (2)Fludarabine Phosphate (3)Miriplatin hydrate, iodine addition products of the ethylesters of the fatty acids obtained from poppyseed oil (MIRIPLA suspension vehicle) Revision of Precautions (No. 226) Ketotifen Fumarate (oral dosage form) (and 12 others) List of Products Subject to Early Post-marketing Phase Vigilance	July 1, 2011	(Summary)
June 29, 2011	280		July 28, 2011	(Full text)
May 25, 2011	279	Project of Japan Drug Information Institute in Pregnancy Safety Measures Related to Lenalidomide Hydrate Important Safety Information (1)Aripiprazole (2)Freeze-dried Live Attenuated Mumps Vaccine (3)Anti-human Thymocyte Immunoglobulin, Rabbit (4)Tacrolimus Hydrate (oral and injectable dosage form) (5)Tolvaptan (6)Pioglitazone Hydrochloride, Pioglitazone Hydrochloride / Glimepiride, Pioglitazone Hydrochloride / Metformin Hydrochloride Revision of Precautions (No. 225) Sanilvudine (and 32 others) List of Products Subject to Early Post-marketing Phase Vigilance	June 3, 2011	(Summary)
May 25, 2011	279		June 29, 2011	(Full text)