Exploring the potential relationship between antineoplastic agents and their association with stomatitis and oral candidiasis in cancer patients

Background Antineoplastic agents can cause oral toxicity, including “antineoplastic agents-associated stomatitis” (AAS) and “antineoplastic agents-associated oral Candidiasis” (AAOC), in children, adults, and older cancer patients. Objective To identify the risk of AAS and AAOC associated with using antineoplastic agents. Methods The FDA FAERS database for spontaneously reported adverse effects of “antineoplastic agents” was searched and analysed for the occurrence of the MedDRA preferred term “stomatitis” and “oral Candidiasis” using “quantitative safety signal analysis”, which contains spontaneous safety reports collected from 1976 to the end of 2021. Results The results of stomatitis in 27477 and oral candidiasis in 3136 case reports from the FDA database, which received antineoplastic agents during the treatment process. Among all three age groups studied, 4 and 7 antineoplastic agents were strongly associated with the occurrence of AAOC and AAS, respectively (reported odds ratio [ROR] > 100), and the lowest association with AAOC and AAS was reported in 19 and 33 antineoplastic agents, respectively (ROR < 1). Conclusion There are several limitations to providing information on the side effects of new antineoplastic agents in drug databases. Signal detection in pharmacovigilance is a process in which safety issues, including possible drug-related side effects, are investigated. Our study highlights the gap in the database regarding the potential risk of AAOC and AAS, as reported by the FDA for new drugs.