Preprint Article Version 1 Preserved in Portico This version is not peer-reviewed

Evaluation of Drug-Induced Dysphagia Profile Using a Japanese Real-World Database: A Pharmacovigilance Study

Version 1 : Received: 12 September 2023 / Approved: 13 September 2023 / Online: 14 September 2023 (04:33:44 CEST)

How to cite: Kose, E.; Kawashima, M.; Yasuno, N. Evaluation of Drug-Induced Dysphagia Profile Using a Japanese Real-World Database: A Pharmacovigilance Study. Preprints 2023, 2023090889. https://doi.org/10.20944/preprints202309.0889.v1 Kose, E.; Kawashima, M.; Yasuno, N. Evaluation of Drug-Induced Dysphagia Profile Using a Japanese Real-World Database: A Pharmacovigilance Study. Preprints 2023, 2023090889. https://doi.org/10.20944/preprints202309.0889.v1

Abstract

Background: no reports have examined the profile of drug-induced dysphagia in detail. The goal of this study was to investigate if there are any differences in the profiles of drug-induced dysphagia. Methods: This study used the Japanese Adverse Drug Event Report (JADER) database. Further, reported odds ratios (RORs) were used to analyze data on adverse drug events from 2004 to 2021. The top ten drugs with the most drug-induced dysphagia occurrences were used as target drugs. The association between RORs and drug-induced dysphagia caused by the target drugs was evaluated, and the age distribution and time of onset of drug-induced dysphagia for each drug were compared. RORs were the primary endpoint. Moreover, age and time of onset of drug-induced dysphagia were secondary outcomes. Results: In total, 756,965 reports were analyzed. All the target drugs were associated with drug-induced dysphagia. Among them, cevimeline was a novel finding, as no dysphagia was observed during the clinical trial. For most drugs, the onset of drug-induced dysphagia was occurring within approximately 25 days of administration. However, even after long-term use, paroxetine and milnacipran were associated with drug-induced dysphagia. Conclusion: The onset profile of drug-induced dysphagia may differ from one drug to the next.

Keywords

adverse drug events; drug-induced dysphagia; Japanese adverse drug event report; reported odds ratios

Subject

Medicine and Pharmacology, Pharmacy

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