MHLW Pharmaceuticals and Medical Devices Safety Information (FY2007)

**FY 2007 (No.235-245)**
Japanese version issued on	No.	Table of contents	PDF
March 27, 2008	245	Treatment of hepatitis viral with interferon products Sudden onset of sleep, etc. associated with non-ergoline dopamine agonists (patients must be advised to refrain from driving, etc.) Important Safety Information (1)Cyclophosphamide (oral dosage form), Cyclophosphamide(injectable dosage form) Revision of PRECAUTIONS (No. 195) Nicorandil (oral dosage form) and 1 other List of products subject to Early Post-marketing Phase Vigilance	Full text [608 KB]
February 28, 2008	244	Revision of PRECAUTIONS (No. 194) GEM-Premier 3000 PAK and 10 others List of products subject to Early Post-marketing Phase Vigilance	Full text [330 KB]
January 29, 2008	243	Revision of PRECAUTIONS (No. 193) Flurbiprofen (oral dosage form) and 6 others List of products subject to Early Post-marketing Phase Vigilance <Reference> About oseltamivir phosphate (Tamiflu) <The brief summary of the review results by the Subcommittee on Drug Safety (held on December 25, 2007)>	Full text [337 KB]
December 26, 2007	242	Important Safety Information (1)Atorvastatin Calcium Hydrate (2)Tizanidine Hydrochloride (3)Thiamazole Revision of PRECAUTIONS (No. 192) Amitriptyline Hydrochloride and 11 others List of products subject to Early Post-marketing Phase Vigilance	Full text [454 KB]
November 29, 2007	241	"PMDA medical safety information" is new posted on the Pharmaceuticals and Medical Devices Information Website Important Safety Information (1)Amiodarone Hydrochloride (oral dosage form), Amiodarone Hydrochloride (injectable dosage form) Revision of PRECAUTIONS (No. 191) (1)Drugs: Pralidoxime Iodide and 13 others (2)Medical Devices: Glucose meters for self-monitoring and 5 others List of products subject to Early Post-marketing Phase Vigilance	Full text [446 KB]
September 27, 2007	240	Reports etc. on adverse reactions associated with influenza vaccines in FY 2006 Revision of PRECAUTIONS (No. 190) (1)Telithromycin and (7 others) (2)Internal fluid pathway type needleless connectors and (1 other) List of products subject to Early Post-marketing Phase Vigilance	Full text [571 KB]
August 30, 2007	239	Important Safety Information (1)Alteplase (Genetical recombination) (2)Oxycodone Hydrochloride Hydrate (3)Meropenem Trihydrate Revision of PRECAUTIONS (No. 189) (1)Amobarbital and (7 others) List of products subject to Early Post-marketing Phase Vigilance	Full text [404 KB]
July 31, 2007	238	Important Safety Information (1)Zolpidem Tartrate (2)Zopiclone Revision of PRECAUTIONS (No. 188) (1)Triazolam and (2 others) (2)Enteral feeding tubes and gastric tubes (only those with stylet or guide wire as kits) and (2 others) List of products subject to Early Post-marketing Phase Vigilance	Full text [367 KB]
June 27, 2007	237	The effect from RFID devices in UHF band and mobile phone terminals with a new system on implantable medical devices such as cardiac pacemakers etc. Important Safety Information (1)Gadodiamide Hydrate (2)Cabergoline (3)Pergolide Mesilate (4)Risperidone Revision of PRECAUTIONS (No. 187) (1)Ampiroxicam (and 7 others) (2)Medical devices such as artificial lungs, blood pumps, and blood circuits etc. that consist of extra-corporeal circuit List of products subject to Early Post-marketing Phase Vigilance <Reference> Manuals for Management of Individual Serious Adverse Drug Reaction Guidelines for Standard Methods of Extra-corporeal Circuit and Its Safety Training	Full text [1.3 MB]
May 31, 2007	236	Post-marketing safety measures for ticlopidine hydrochloride products and TAXUS Express2 Stent Important Safety Information (1)Edaravone (2)Amiodarone Hydrochloride (oral dosage form) (3)Cibenzoline Succinate (oral dosage form) Revision of PRECAUTIONS (No. 186) Oseltamivir Phosphate (and 11 others) List of products subject to Early Post-marketing Phase Vigilance	Full text [475 KB]
April 26, 2007	235	Standardization of the number of drops for infusion sets and blood transfusion sets Project of Japan Drug Information Institute in Pregnancy Safety Information on the "Pharmaceuticals and Medical Devices Information Website" of the Pharmaceuticals and Medical Devices Agency List of products subject to Early Post-marketing Phase Vigilance <Reference> Oseltamivir Phosphate Overview of Pharmacogenomics (Warfarin therapy and genetic polymorphism)	Full text [623 KB]