Pmda - Pharmaceuticals and Medical Devices Agency

Post-marketing Safety Measures

PMDA Alert for Proper Use of Drugs

PMDA Alert for Proper Use of Drugs provides information on the proper use of pharmaceutical products for which patients applied for relief benefits or cases of adverse reactions were reported repeatedly, in spite of the fact that precautions for those drugs had been already issued in package inserts or in other ways. This page is intended to make easy-to-understand explanations using graphic illustrations on such safety matters to which healthcare professionals should pay attention, encouraging them to thoroughly continue the proper use of drugs.

Note) This English version of PMDA Alert for Proper Use of Drugs is intended to be a reference material to provide convenience for users. In the event of inconsistency between the Japanese original and this English translation, the former shall prevail. The PMDA shall not be responsible for any consequences resulting from the use of this English version.

Posted on No. Title
July 2023 15 Appropriate Measures to Be Taken for Pemphigoid Due to Dipeptidyl Peptidase-4 (DPP-4) Inhibitors
October 2022
April 2022
14 Ovarian Hyperstimulation Syndrome Caused by Drugs Used for Treatment of Infertility
October 2020 13 Hypercalcaemia Induced by Eldecalcitol and Adherence to Blood Testing
October 2019 12 Serious Skin Disorders with Lamotrigine and Adherence to Dosage and Administration
May 2024
March 2017
11 Dependence Associated with Benzodiazepine Receptor Agonists
May 2023
September 2014
10 Precautions for Use of the Drugs Inhibiting the Renin-Angiotensin System (ACE Inhibitors, ARB, Etc.) in Women of Child-bearing Potential
June 2012 9 Early Detection of Drug-induced Serious Skin Disorders
May 2012 8 Serious hypocarnitinemia and hypoglycaemia in children treated with antibacterials with a pivoxil group
October 2012
May 2012
7 Compliance with Measurement of Blood Lithium Level during Treatment with Lithium Carbonate
February 2012 6 Compliance with Dosage and Administration and Ensuring Early Detection for Lamictal Tablets (lamotorigine)-induced Serious Skin Disorders
December 2011 5 Periodic blood tests and symptom checks should be performed for prevention and early detection of agranulocytosis associated with the antithyroid drug thiamazole.
November 2011 4 Recommendation of periodic liver function tests and monitoring of signs/symptoms for patients treated with the gout/hyperuricaemia treatment benzbromarone
October 2011 3 Hepatitis B viral growth associated with the use of drugs with immunosupressive effects
October 2011 2 Automobile accidents associated with the use of smoking cessation aid CHAMPIX (varenicline tartrate)
August 2010 1 Compliance with conduct of laboratory tests before and after administration of salazosulfapyridine