MHLW Pharmaceuticals and Medical Devices Safety Information (FY2014)

1. Lamotrigine and Serious Skin Disorders
2. Abiraterone Acetate and Hypokalaemia
3. The MIHARI Project
4. Important Safety Information

(1)abiraterone acetate

(2)lamotrigine

(3)apixaban

(4)memantine hydrochloride

5. Revision of Precautions (No. 263)
   Montelukast sodium and telaprevir
6. List of Products Subject to Early Post-marketing Phase Vigilance (as of March 2015)

1. Cabazitaxel Acetonate and Severe Febrile Neutropenia
2. Use of Capsule Endoscopy for Small Intestine Screening in Pediatrics and Geriatrics
3. Important Safety Information

(1)cabazitaxel acetonate

(2)sodium-glucose co-transporter 2 inhibitors

(3)freeze-dried live attenuated mumps virus vaccine

(4)levetiracetam

4. Revision of Precautions (No. 262)
   Linagliptin (and 2 others)
5. List of Products Subject to Early Post-marketing Phase Vigilance (as of January 2015)

1.  Summary of the Relief System for Sufferers from Adverse Drug Reactions and the Cases of Non-payment of Relief Benefits Due to Improper Use of Drugs
2. Revision of Precautions (No. 261)
3. List of Products Subject to Early Post-marketing Phase Vigilance  (as of December 2014)

1. Simeprevir Sodium and Hyperbilirubinaemia
2. Surveillance on Access to, Dissemination, and Utilization of Drug Safety Information in Medical Institutions and Pharmacies
3. Adverse Reactions to Influenza Vaccine in the 2013 Season
4. Important Safety Information

(1)Enzalutamide

(2)Teneligliptin hydrobromide hydrate

(3)Vancomycin hydrochloride (for injection)

(4)Simeprevir sodium

5. Revision of Precautions (No. 260)
   Acetaminophen and vancomycin hydrochloride (oral dosage form)
6. List of Products Subject to Early Post-marketing Phase Vigilance (as of November 2014)

1. Guidelines for Use of Mobile Phones and Other Devices in Hospitals
2. Change in the Submission Place of Reports in the Safety Information Reporting System
3. Important Safety Information

(1)Imatinib mesilate

(2)Pregabalin

4. List of Products Subject to Early Post-marketing Phase Vigilance (as of October 2014)

1. Project of Japan Drug Information Institute in Pregnancy
2. Effects of Angiotensin II Receptor Blockers and Angiotensin Converting Enzyme Inhibitors on Pregnant Women and Foetuses
3. Revision of Precautions (No. 259)
   Paroxetine Hydrochloride Hydrate (and 9 others)
4. List of Products Subject to Early Post-marketing Phase Vigilance (as of September 2014)

1. Safety Measures of New Drugs during the Early Post-marketing Phase
2. Important Safety Information

   (1)Inchinkoto

   (2)Simeprevir Sodium

   (3)Teriparatide (Genetical Recombination)

   (4)Loratadine

3. Revision of Precautions (No. 258)
   Paroxetine Hydrochloride Hydrate (and 3 others)
4. List of Products Subject to Early Post-marketing Phase Vigilance (as of August 2014)

1. Revision of Report Form in Drugs and Medical Devices Safety Information Reporting System
2. Revision of Precautions (No. 257)

   (1)Azilsartan (and 7 others)

3. List of Products Subject to Early Post-marketing Phase Vigilance (as of July 2014)

1. Fatal cases with XEPLION® Aqueous Suspension for IM injection
2. Important Safety Information

   (1)Paliperidone Palmitate

3. Revision of Precautions (No. 256)

   (1)Pentamidine Isetionate

4. List of Products Subject to Early Post-marketing Phase Vigilance (as of May 2014)

1. Use of Topical Ketoprofen during Pregnancy
2. Important Safety Information

   (1)Ketoprofen (tapes)

   (2)Paclitaxel (excluding paclitaxel protein-bound particles for injectable suspension)

   (3)Levetiracetam

3. Revision of Precautions (No. 255)

   (1)Ketoprofen (injectable dosage form, suppository) (and 7 others)

4. List of Products Subject to Early Post-marketing Phase Vigilance (as of April 2014)