Irreversible Atorvastatin‐Associated Hearing Loss

Abstract

Drug-associated ototoxicity is a potentially irreversible adverse event. Among the several 3-hydroxy-3-methylglutaryl coenzyme A reductase inhibitors (statins) available in the United States, only atorvastatin is associated with tinnitus, but none are associated with any forms of hearing loss. A search of the published literature (1950-August 2011) revealed no published case reports of ototoxicity associated with statins. To our knowledge, we describe the first case of progressive, irreversible hearing loss in a 32-year-old man 18 months after starting atorvastatin therapy. He began taking atorvastatin 20 mg every evening for treatment of hypercholesterolemia. Six months later, he complained of occasional episodes of tinnitus, which resolved spontaneously. An audiogram was obtained and was normal. By 18 months, the tinnitus became continuous. Another audiogram revealed bilateral "cookie-bite" middle-frequency hearing loss. Atorvastatin was immediately discontinued, and the patient was fitted with hearing aids. Four years after drug discontinuation, his hearing loss had neither progressed nor regressed. Use of the Naranjo adverse drug reaction probability scale indicated a possible (score of 2) temporal and causal relationship between the patient's hearing loss and atorvastatin. Causes of "cookie-bite" hearing loss include chronic exposure to loud noises, presbycusis, genetic predisposition, and drugs. The manufacturer of atorvastatin has received three unpublished cases of deafness, but claims that causal relationships were not established. Despite these claims by the manufacturer, based on this case report, we recommend that clinicians and patients be aware of the risk of atorvastatin-associated tinnitus and permanent hearing loss. Further research is needed to better understand the mechanism and frequency of this adverse event.

<p>Association of atorvastatin with the risk of hepatotoxicity: a pilot prescription sequence symmetry analysis</p>

“…Common adverse drug events (ADEs) or adverse drug reactions (ADRs) for patients taking ATO include arthralgia, dyspepsia, diarrhea, nausea, nasopharyngitis, insomnia, urinary tract infection and pain in the extremities 13. Additionally, ATO-associated myalgia,11 hearing loss,14 and hepatotoxicity15,16 are often reported. Idiosyncratic liver injury associated with statins is rare but can be associated with severe outcomes,17 and the research on this topic is incomplete but extremely necessary 18…”

Drug‐induced hearing loss: a case/non‐case study in the French pharmacovigilance database

“…The occurrence of hearing loss was mentioned as common or uncommon, according to the SmPC. It is rare but well described for phosphodiesterase inhibitors , quinine and hydroxychloroquine , atorvastatin , macrolides , and antifungal drugs such as amphotericin B . Cases of hearing loss were observed with fluoroquinolones, imipenem, and isotretinoin according to their SmPC.…”

Effect of statins on hearing function and subjective tinnitus in hyperlipidemic patients

“…They detected a statistically significant relationship between SSNHL and previous statin use, regardless of whether statin is used regularly. Liu M. et al [22] reported a progressive and irreversible hearing loss in a 32-year-old male patient after atorvastatin treatment at 18 months. The patient described recurrent and spontaneously recovering hearing loss six months after the start of treatment.…”