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

Eiko Iwasa, Yu Fujiyoshi, Yuki Kubota, Ryota Kimura, Rebecca E. Chandler, Henric Taavola, G. Niklas Norén and Rika Wakao ()
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Eiko Iwasa: Pharmaceuticals and Medical Devices Agency (PMDA)
Yu Fujiyoshi: Pharmaceuticals and Medical Devices Agency (PMDA)
Yuki Kubota: Pharmaceuticals and Medical Devices Agency (PMDA)
Ryota Kimura: Pharmaceuticals and Medical Devices Agency (PMDA)
Rebecca E. Chandler: Uppsala Monitoring Centre
Henric Taavola: Uppsala Monitoring Centre
G. Niklas Norén: Uppsala Monitoring Centre
Rika Wakao: Pharmaceuticals and Medical Devices Agency (PMDA)

Drug Safety, 2020, vol. 43, issue 11, No 5, 1131 pages

Abstract: 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 methotrexate. Results Interstitial lung disease-related label changes predominantly occurred for drugs in the anatomical therapeutic chemical classification groups L, J, C, and herbal medicines. Interstitial lung disease was reported most frequently for L group, especially for the protein kinase inhibitors. The regulatory actions for those drugs with the highest number of interstitial lung disease reports (methotrexate, protease kinase inhibitors, gemcitabine, docetaxel) plus monoclonal antibodies were analyzed. The ratio of interstitial lung disease reports to all reports over time was initially high in the re-examination period, while it was constantly low after the period expired. The increase in interstitial lung disease reporting was observed for the drugs for which interstitial lung disease was designated as a priority item in the use-results survey. Methotrexate had more interstitial lung disease reports with multiple suspected drugs and fewer reports with high completeness than the protease kinase inhibitors. Conclusions The high rates of interstitial lung disease reporting derived from mainly the anatomical therapeutic chemical classification group L drugs. Interstitial lung disease is the targeted adverse drug reaction in the use-results survey mandated in the re-examination of those drugs. This system provides at least one explanation for the high reporting of interstitial lung disease in Japan.

Date: 2020
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DOI: 10.1007/s40264-020-00968-7

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