Tepezza Linked to Hypoacusis, Hyperacusis, Autophony, Other Hearing Problems Which May be Irreversible and Permanent
(Posted by Tom Lamb at Drug Injury Watch)
Tepezza is a relatively new treatment for Thyroid Eye Disease, approved by the FDA in 2020. Since then, an increasing number of Tepezza hearing side effects cases have been reported by medical doctors and patients.
From our review of various medical journal articles, those Tepezza hearing side effects case reports have involved various hearing problems, such as:
- Hearing loss, ranging from impairment to deafness -- also known as Hypoacusis, and sometimes Sensorineural Hearing Loss (SNHL)
- Sound or noise sensitivity that makes it hard to deal with everyday sounds -- also known as Hyperacusis
- Ringing in the ears in the absence of an external source-- also known as Tinnitus
- Unusually loud hearing of one’s own voice, breathing, and other bodily sounds -- also known as Autophony
- Sensations of ears being "plugged" or "full" resulting in muffled hearing -- also known as Eustachian Tube Dysfunction
The current Tepezza Full Prescribing Information (Revised: October 2021) document does not include any mention of hearing side effects in the "Warnings and Precautions" section nor in the "Adverse Reactions" section. In the "Clinical Trials Experience" section -- found at part 6.1 of the Tepezza Full Prescribing Information, which is sometimes referred to as the Tepezza drug label -- there is a statistic about what could be described as Tepezza hearing side effects. Specifically, within Table 1, it is reported that 10% of the patients who participated in two clinical studies experienced "Hearing impairment", defined as follows in a note that is part of Table 1:
Hearing impairment (includes deafness, eustachian tube dysfunction, hyperacusis, hypoacusis and autophony)
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Perhaps based on this Tepezza clinical studies statistic, in October 2022 Tepezza drug maker Horizon Therapeutics asked an Illinois federal court judge to dismiss claims made in a Tepezza drug injury lawsuit alleging that Horizon failed to warn that Tepezza can cause permanent hearing loss.
The possibility that Tepezza hearing loss can be irreversible and permanent is a subject that has been examined in several recent medical journal articles about Tepezza (teprotumumab) and continues to be studied. There are case reports, however, where the patient's hearing loss was still present several months after they stopped their Tepezza use, and the level of hearing function was still not back to where it had been before their Tepezza use.
As background, in January 2020 Tepezza received approval from the FDA for the treatment of thyroid eye disease (TED), which is also referred to as Graves' disease, Graves' eye disease (GED), Graves' orbitopathy, and Graves’ ophthalmopathy. Tepezza (teprotumumab) is a fully human IgG1 monoclonal antibody against insulin-like growth factor-1 receptor (IGF-1R).
We are investigating possible Tepezza drug injury cases where the patient, while using Tepezza, started to experience "new" hearing problems, such as:
- Hypoacusis: hearing loss ranging from impairment to deafness
- Sensorineural Hearing Loss (SNHL): type of hearing loss resulting from damaged hair cells in the inner ear
- Hyperacusis: sound or noise sensitivity that makes it hard to deal with everyday sounds
- Tinnitus: ringing in the ears in the absence of an external source
- Autophony: unusually loud hearing of one’s own voice, breathing, and other bodily sounds
- Eustachian Tube Dysfunction: sensations of ears being "plugged" or "full" resulting in muffled hearing
If you or someone you know has a possible Tepezza hearing side effects case, we encourage you to submit a Drug Injury Case Evaluation Form — it is free, confidential, and there is no obligation. Or you can call us toll-free at (800) 426-9535 to speak directly to attorney Tom Lamb about a possible Tepezza drug injury case.
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