Analysis of the Possibility of Drug-Induced Aspiration Pneumonia Due to Anxiolytics by Using the Japanese Adverse Drug Event Report Database

Abstract

With societal aging, the number of patients with aspiration pneumonia is increasing. However, because the relationship between drug use and the development of aspiration pneumonia is not fully understood, improvements in information on the possibility of drug-induced aspiration pneumonia are urgently needed. Hence, in this study, we investigated the relationship between the use of anxiolytics and the development of aspiration pneumonia by using data from the Japan Adverse Drug Event Report (JADER) database. We found that anxiolytics had a signal for the development of aspiration pneumonia with a reporting odds ratio (ROR) of 3.2 (95% confidence interval: 2.5–4.1), and seven of eight anxiolytics for which the development of aspiration pneumonia was reported in the JADER database had a signal as well. Of note, the possibility of the development of aspiration pneumonia was mentioned only in the package inserts of clobazam among the package inserts or risk management plans (RMPs) of these anxiolytics. These results suggest the need for including information on the possibility of aspiration pneumonia development in drug package inserts and RMPs so as to prevent anxiolytic-associated aspiration pneumonia or facilitate its early detection.