Interstitial Lung Disease as an Adverse Drug Reaction in Japan: Exploration of Regulatory Actions as a Basis for High Reporting.

ABSTRACT:

Introduction

Increased post-marketing reports of interstitial lung disease in Japan have been recognized. An understanding of its regional groundings can be important for the global pharmacovigilance community.

Objective

The objective of this study was to explore the correlation between high rates of interstitial lung disease reporting and regulatory actions in Japan.

Methods

Post-marketing interstitial lung disease-related label changes and interstitial lung disease reports were classified by the anatomical therapeutic chemical classification groups of the suspected drugs. Regulatory actions for the top interstitial lung disease-reporting drugs were compared. The interstitial lung disease reporting patterns of protein kinase inhibitors were compared to those of metho

SUBMITTER: Iwasa E 

PROVIDER: S-EPMC7575479 | biostudies-literature | 2020 Nov

REPOSITORIES: biostudies-literature