Drug-induced hearing loss: a real-world pharmacovigilance study using the FDA adverse event reporting system database

Abstract

Drug-induced hearing loss (DIHL) is highly prevalent, but a comprehensive picture of ototoxicity associated with drugs are still lacking. In order to comprehensively summarize the hearing safety information of current drugs, we used the real-world data from 2004 to 2023 in the FDA Adverse Event Reporting System (FAERS) database to integrate the reported ototoxicity information of drugs and applied disproportionality analysis to evaluate the hearing impairment risk induced by drugs. A total of 108,435 adverse event (AE) reports of hearing impairment were extracted from the FAERS database, involving 1300 reported culprit-drugs. On the whole, acetylsalicylic acid was the most frequently reported potential ototoxic drug, followed by levothyroxine sodium, adalimumab, omeprazole, and ergocalciferol. Immunosuppressants was the most frequently reported drug class, followed by analgesics, psychoanaleptics, agents acting on the renin-angiotensin system, and antineoplastic agents. In risk signal detection, 432 of 1300 drugs exhibited potential ototoxic risk, in which tafenoquine showed the strongest statistical correlation with hearing impairment, followed by teprotumumab, amyl nitrite, potassium iodide, and paromomycin. Among main drug classes, antibacterials for systemic use was the drug class contained the maximum number of drugs with positive ototoxic risk signals, followed by psychoanaleptics, agents acting on the renin-angiotensin system, antineoplastic agents, and analgesics. In conclusion, our study summarized a comprehensive drug list containing 1300 reported potential ototoxic drugs in the FAERS database and profiled their ototoxicity risk characteristic from the aspect of reporting frequency and risk signal strength, which can provide reference for clinical medical staff to strengthen monitoring and management of DIHL.