Neurotoxicity induced by taxane-derived drugs: analysis of the FAERS database 2017–2021

Abstract

ABSTRACT Objectives Taxane‐related neurotoxicity is a frequent clinical problem but lacks postmarketing data regarding neurological disorders. This study aimed to evaluate the potential association between neurological adverse events and several taxanederived drugs via the Food and Drug Administration Adverse Event Reporting System (FAERS). Methods Disproportionality analysis was applied to data mining of the suspected cases of neurological disorders after using different taxanes based on the FAERS data from January 2017 and December 2021. We also investigated the times to onset, fatality, and hospitalization proportions of taxanerelated neurotoxicity. Results In total, 3,940 cases were screened out, which were more prevalent in elderly patients and females. Peripheral neuropathy was a common adverse event among all taxanes with relatively strong association. Generally, the median time to neurological adverse effect onset was 27 days (interquartile range, 11.0 ~ 78.0 days) following taxane regimens, and the majority of cases were detected within the first 30 days. Among cases of neurological adverse events treated with taxane, the fatality and hospitalization proportions were 6.13% and 28.63%, respectively. Conclusion By analyzing the FAERS data, we provided a detailed profile of neurotoxicity and different taxanes in detail in terms of clinical characteristics, time to onset, and patient outcomes.