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Chinese Journal of Clinical Pharmacology and Therapeutics ›› 2023, Vol. 28 ›› Issue (10): 1109-1120.doi: 10.12092/j.issn.1009-2501.2023.10.004

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Drug-induced dysphagia risk in elder people——A pharmacovigilance study of FDA Adverse Event Reporting System (FAERS) database

JIA Boying1, ZHOU Shuang2, WAN Liyan1, ZHOU Ying2, CUI Yimin2    

  1. 1 Department of Pharmacy ,The First Hospital of Tsinghua University, Beijing 100016, China; 2 Department of Pharmacy, Peking University First Hospital, Beijing 100034, China 
  • Received:2023-05-15 Revised:2023-07-11 Online:2023-10-26 Published:2023-10-26

Abstract:

AIM: To evaluate the risk of drug-related dysphagia in elder people based on the FDA Adverse Event Reporting System (FAERS). METHODS: We collected the reports of dysphagia in elder people (Age≥65) from 2004 quarter 1 through 2022 quarter 2 of FAERS by Open Vigil 2.1 database. The reported odds ratio (ROR) and the proportional reported ratio (PRR) were calculated to detect the adverse reaction signal of drug-induced dysphagia in elder people. Signal generation standard of ROR: number of reports≥3 with the lower limit of 95% confidence interval (CI) of the ROR value>1, PRR≥2 and c2≥4, which indicates positive signal. RESULTS: A total of 51, 590 reports (including 13,197 dysphagia events and 1,395 drug) were considered, and 350 positive signal drugs were detected. The Median age of the included patients was 75 years,and there were more females than males. Positive signal drugs are mainly concentrated on nervous system [n=99, ROR 2.17(1.97-2.39)] , alimentary tract and metabolism [n=47, ROR 1.44(1.25-1.66)], cardiovascular system [n=42, ROR 1.30(1.22-1.39)], anti-infectives for systemic use [n=27, ROR 1.44(1.29-1.61)]. CONCLUSION: Drug-induced dysphagia risk are widespread according to the FAERS. It is recommended that multidisciplinary teams should assess the swallowing status of potients when selecting drugs. For elderly patients with high risk of swallowing, priority should be given to drugs with negative signals of dysphgia. When the preferred  drugs fail to meet the clinical need, it is recommended to select drug with lowe risk.Simultaneous clinical need to supervise the application of drugs in the process to prevent the occurrence of dysphagia events.

Key words: elder patients, drug-induced dysphagia, FARES, pharmacovigilance, drug safety

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