In recent years, Tepezza, a medication primarily prescribed for the treatment of thyroid eye disease, has garnered significant attention within the medical community. While hailed for its efficacy in managing this challenging condition, the medication has also come under scrutiny due to its link to hearing loss.
This development has prompted a surge in medical research endeavors and the documentation of compelling case studies. All of which seek to understand the intricate relationship between Tepezza and auditory impairment.
In this article, we will delve into the instances where Tepezza treatment has been associated with hearing loss.
How Is Hearing Loss Associated With Tepezza?
Tepezza, also known as teprotumumab, is an FDA-approved biologic drug. It demonstrates effectiveness in reducing eye inflammation, improving eye appearance, and restoring eye function in thyroid eye disease (TED) patients.
Hearing loss is a known side effect of Tepezza. The exact mechanism by which Tepezza causes hearing loss is not fully understood. However, it is believed that the drug may damage the cochlea, the inner ear structure responsible for hearing.
More recently, users have filed a Tepezza hearing loss lawsuit against the drug’s manufacturer, Horizon Therapeutics. These lawsuits allege that Horizon failed to adequately warn patients and doctors about the risk of hearing loss associated with Tepezza.
Furthermore, the lawsuits claim that Horizon was aware of this risk but downplayed it during clinical trials and in marketing materials.
According to TorHoerman Law, the Tepezza lawsuit is still in its early stages, and its ultimate resolution remains uncertain. However, it has shed light on the potential risk of hearing loss associated with this drug.
Medical Research on Hearing Loss from Tepezza
Clinical trials conducted during the development of Tepezza initially reported a relatively low incidence of hearing loss at approximately 10%. However, recent findings have raised concerns.
A single-center study presented at ENDO 2021 revealed a significantly higher rate of otologic symptoms, including hearing loss, among TED patients treated with Tepezza. More than half of the patients who received four infusions of Tepezza reported experiencing hearing loss symptoms, a stark contrast to the trial data.
These symptoms included subjective hearing loss, new tinnitus, ear-plugging sensations, and muffled hearing. Notably, these symptoms typically manifested after an average of 3.6 infusions.
Furthermore, according to Investigative Ophthalmology & Visual Science, there have been recent reports suggesting an astonishing 81% incidence of otologic symptoms. This includes hearing loss among Tepezza-treated patients.
However, a standardized protocol for managing hearing loss in this context has yet to be established. Notably, some reports have suggested successful treatment of Tepezza-related hearing loss with prompt oral prednisone. This underscores the need for further research and clinical guidelines in addressing this concerning side effect.
Case Studies of Hearing Loss from Tepezza
Cases of hearing loss from Tepezza have revealed diverse patient experiences with different types of hearing loss, varying durations, and distinct outcomes.
One notable case involves Daniel Weibel, who filed one of the first lawsuits against Horizon Therapeutics in August 2022. Weibel, a patient seeking treatment for thyroid eye disease, underwent Tepezza therapy only to experience permanent hearing loss. This case set a precedent for subsequent legal actions as more patients have come forward with similar claims.
In another case detailed by BMJ, a woman in her 50s with chronic thyroid eye disease received Tepezza treatment. She developed tinnitus after the third dose and subsequently experienced sensorineural hearing loss after the fifth dose. Audiograms revealed bilateral mild to moderate-severe hearing loss, significantly worse than her baseline audiogram before treatment.
Despite discontinuing Tepezza, her hearing loss remained irreversible, highlighting the importance of ongoing audiometric monitoring during and after Tepezza therapy.
The magnitude of these cases is reflected in the legal landscape. The U.S. Judicial Panel is considering the consolidation of multiple hearing loss lawsuits brought against Horizon Therapeutics.
Currently, there are at least 18 cases filed in various U.S. District Courts related to hearing loss claims associated with Tepezza. However, it is anticipated that this number will substantially increase, considering the prevalence of Graves’ disease and a high incidence of Tepezza-related hearing loss.
Consequently, this litigation has the potential to encompass more than 1,000 lawsuits, underscoring the growing apprehension surrounding Tepezza.
Management of Hearing Loss
Patients who are taking Tepezza should be monitored for hearing loss. This can be done with regular audiograms, which are tests that measure hearing. Audiograms should be performed before starting Tepezza and then regularly throughout treatment.
If a patient experiences hearing loss while taking Tepezza, they should see their doctor right away.
There is no cure for hearing loss, but there are treatments that can help to improve hearing and communication. Treatment options for hearing loss include:
- Hearing aids: Hearing aids are electronic devices that amplify sound. They can be worn in the ear or behind it.
- Cochlear implants: Cochlear implants are devices that are surgically implanted to circumvent the impairment of the inner ear by transmitting signals directly to the brain.
- Assistive listening devices: Assistive listening devices can help to amplify sound in specific situations, such as in noisy environments or when watching television.
The best treatment option for hearing loss will vary depending on the individual patient’s needs and preferences.
The emerging body of evidence and case studies regarding hearing loss associated with Tepezza underscores the urgency of addressing this concerning side effect. While Tepezza has proven effective in treating thyroid eye disease, the potential risk of hearing loss cannot be ignored.
As research, legal proceedings, and medical guidelines evolve, healthcare providers, patients, and pharmaceutical companies must collaborate. Together, they can manage thyroid eye disease effectively while mitigating the risk of hearing loss and ensuring patient safety.
The path forward requires a balanced approach that addresses both the therapeutic benefits of Tepezza and the potential hearing-related challenges it may pose.