Japan PMDA Drug Safety Alerts, 16 Alerts Listed
Summary
PMDA publishes a reference index of 16 drug safety alerts for healthcare professionals, covering drug classes including COVID-19 treatments (Xocova, Lagevrio), DPP-4 inhibitors, benzodiazepine receptor agonists, and drugs such as lamotrigine, thiamazole, and benzbromarone. Alerts range from Alert No. 1 (August 2010) through Alert No. 16 (December 2024), with several marked as revised. The English version is noted as a convenience translation with the Japanese original prevailing in case of inconsistency.
“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.”
About this source
GovPing monitors Japan PMDA Safety (EN) for new healthcare & life sciences regulatory changes. Every update since tracking began is archived, classified, and available as free RSS or email alerts — 3 changes logged to date.
What changed
PMDA published an updated English-language reference index listing 16 drug safety alerts spanning August 2010 through December 2024. Each alert addresses a specific drug safety concern requiring healthcare professional attention, including blood monitoring for thiamazole, skin disorder precautions for lamotrigine, and lithium level compliance. Several alerts carry revision dates extending into 2025.
Healthcare providers and pharmaceutical companies operating in Japan should treat these alerts as key reference material for proper drug use. While the English version is explicitly marked as non-authoritative, it provides a convenient consolidated index for international stakeholders seeking to understand PMDA's drug safety communication priorities.
Archived snapshot
Apr 23, 2026GovPing captured this document from the original source. If the source has since changed or been removed, this is the text as it existed at that time.
日本語ページはこちら 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.
| Date | No. | Title |
|---|---|---|
| December 2024 | 16 | Administration of Treatment Drugs for COVID-19 (Xocova Tablets and Lagevrio Capsules) to Women of Childbearing Potential [453 KB] |
| July 2023 | 15 | Appropriate Measures to Be Taken for Pemphigoid Due to Dipeptidyl Peptidase-4 (DPP-4) Inhibitors |
| [192 KB] | ||
| October 2022 |
(revised)
April 2022 | 14 | Ovarian Hyperstimulation Syndrome Caused by Drugs Used for Treatment of Infertility
[273 KB] |
| October 2020 | 13 | Hypercalcaemia Induced by Eldecalcitol and Adherence to Blood Testing
[491 KB] |
| October 2019 | 12 | Serious Skin Disorders with Lamotrigine and Adherence to Dosage and Administration
[502 KB] |
| May 2024
(revised)
March 2017 | 11 | Dependence Associated with Benzodiazepine Receptor Agonists
[91.3 KB] |
| May 2023
(revised)
September 2014 | 10 | Precautions for Use of the Drugs Inhibiting the Renin-Angiotensin System (ACE Inhibitors, ARB, Etc.) in Women of Child-bearing Potential
[315 KB] |
| June 2012 | 9 | Early Detection of Drug-induced Serious Skin Disorders
[142 KB] |
| May 2012 | 8 | Serious hypocarnitinemia and hypoglycaemia in children treated with antibacterials with a pivoxil group
[214 KB] |
| September 2025
(revised)
September 2012 | 7 | Compliance with Measurement of Blood Lithium Levels during Treatment with Lithium Carbonate
[234 KB] |
| February 2012 | 6 | Compliance with Dosage and Administration and Ensuring Early Detection for Lamictal Tablets (lamotorigine)-induced Serious Skin Disorders
[309 KB] |
| July 2025
(revised)
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.
[290 KB] |
| November 2011 | 4 | Recommendation of periodic liver function tests and monitoring of signs/symptoms for patients treated with the gout/hyperuricaemia treatment benzbromarone
[227 KB] |
| October 2011 | 3 | Hepatitis B viral growth associated with the use of drugs with immunosupressive effects
[179 KB] |
| October 2011 | 2 | Automobile accidents associated with the use of smoking cessation aid CHAMPIX (varenicline tartrate)
[349 KB] |
| August 2010 | 1 | Compliance with conduct of laboratory tests before and after administration of salazosulfapyridine
[151 KB] |
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