OBJECTIVES: Through the use of FDA adverse event reporting system (FAERS) dataset, this study analyzes the pattern of time-to-event (TTE) for drugs and adverse events, and suggest ways to identify candidate late-onset events for monitoring.
METHODS: The duration between administration date of the drug and the onset of adverse events was explored with using FAERS data from 2012-2021. The fold change of proportional reporting ratios or reporting odds ratios were calculated to identify enriched events in the later period and to suggest the late-onset events for further monitoring. To compare the findings, we used the claims database of the Korean National Health Insurance Service (NHIS).
RESULTS: A total of 1,426,781 reports were included. The median TTE was 10 days (interquartile range [IQR]: 0-98 days), with 11.5% (n = 164,093) reporting events that occurred at least one year after administration. TTE and fold change analysis captured historical cases of late-onset events, while generating an additional less-explored list of events. The results for tumor necrosis factor (TNF) inhibitors were compared using the NHIS dataset.
CONCLUSION: Our study provides a comprehensive analysis of the FAERS dataset, focusing on TTE data. Periodic summarization of reports would be helpful in monitoring the late-onset events.
|Expert opinion on drug safety
|Kim, Jae Hyun; Song, Yun-Kyoung
|School of Pharmacy and Institute of New Drug Development, Jeonbuk National;University, Jeonju Republic of Korea.;College of Pharmacy, Daegu Catholic University, Gyeongbuk Republic of Korea.