There is limited pharmacoepidemiologic work that focuses on the effects that medications have on ear disease and ear health, yet there is a lot to learn. Our work is tackling two areas that are well-recognized and prominent areas in otology: medication ototoxicity and risk-benefit of antibiotic use. Other work in drugs & ears has evolved from our collaborations and this ongoing work, all with the goal to optimize the use of medications in otology.

Drug Risk benefit / optimizing drug use
Drugs & Hearing Loss
Several drugs are known to cause hearing loss, but many gaps exist in our understanding of medication ototoxicity, ranging from risk of fetal exposure to risk factors among older adults. We have evaluated several emerging concerns about ototoxicity ranging from phosphodiesterase inhibitors to macrolide antibiotics. To facilitate this work we have developed algorithms to measure sensorineural hearing loss and are planning further validation studies to enhance our ability to draw causal inferences. Other future plans include a more concerted focus on prenatal exposure and hearing loss in infants and big data approaches to understand the contribution of medications and their interplay with other factors contributing to hearing loss in adults.
Key publications
- Alrwisan A, Antonelli PJ, Winterstein AG. Azithromycin and sensorineural hearing loss in adults: a retrospective cohort study. Otol Neurotol. 2018;39(8):957-963.
- Liu W, Antonelli PJ, Dahm P, Gerhard T, Delayne JAC, Segal R, Crystal S, Winterstein AG. Risk of sudden sensorineural hearing loss in adults using phosphodiesterase type 5 inhibitors: a population-based cohort study. Pharmcoepidemiol Drug Safety 2018;27(6):587-595.
- Winterstein AG, Liu W, Xu D, Antonelli PJ. Sensorineural hearing loss associated with neomycin eardrums and non-intact tympanic membranes. Otol Head Neck Surgery 2013;148(2):277-83.
- Winterstein AG, Hincapie-Castillo J, Xu D, Liu W, Antonelli PJ. Ototopical neomycin in children with non-intact tympanic membrane. Laryngoscope 2012;122(11):2529-32.

Drug risk benefit and drug use
Drugs & Otitis
Many cases of acute otitis media (AOM) are self-limiting and may be treated with watchful waiting. While reducing antibiotic use in treating one of the most common pediatric infectious diseases offers a tremendous public health benefit in reducing antibiotic resistance, there is a rare but significant risk for complications when AOM untreated. There are also important patient-level considerations on risk benefit such as with the use of fluoroquinolone and tissue toxicity. Our work characterizes and evaluates treatment approaches with the ultimate goal to optimize antibiotic use.
Key publications
- Smolinski NE, Antonelli PJ, Winterstein AG. Watchful waiting for acute otitis media. Pediatrics 2022;150(1):e2021055613
- Wang X, Winterstein AG, Antonelli PJ. Use of systemic antibiotics for acute otitis external: impact of a clinical practice guidelines. Otol Neurotol 2018;39(9):1088-1094
- Winterstein AG, Antonelli PJ. Triangulation of pharmacoepidemiology and laboratory science to tackle otic quinolone safety. Basic Clin Pharmacol Toxicol. 2022 Jan;130 Suppl 1(Suppl 1):75-80
- Tran PT, Antonelli PJ, Hincapie-Castillo JM, Winterstein AG. Association of US Food and Drug Administration Removal of Indications for Use of Oral Quinolones With Prescribing Trends. JAMA Intern Med. 2021 Jun 1;181(6):808-816
- Tran PT, Winterstein AG, Wang X, Rhew K, Antonelli PJ. Appropriateness of Otic Quinolone Use among Privately Insured US Patients. Otolaryngol Head Neck Surg. 2020 Jan;162(1):102-107
- Wang X, Winterstein AG, Alrwisan A, Antonelli PJ. Risk for Tympanic Membrane Perforation After Quinolone Ear Drops for Acute Otitis Externa. Clin Infect Dis. 2020 Mar 3;70(6):1103-1109
- Alrwisan A, Antonelli PJ, Winterstein AG. Quinolone Ear Drops After Tympanostomy Tubes and the Risk of Eardrum Perforation: A Retrospective Cohort Study. Clin Infect Dis. 2017 Apr 15;64(8):1052-1058