Tepezza marks a milestone as the first FDA-approved prescription drug for treating thyroid eye disease, also known as Grave’s eye disease. This condition involves inflammation of the eyes and the surrounding muscles and glands.
However, recent findings have linked teprotumumab, the active ingredient in Tepezza, to potential side effects such as permanent loss of hearing. This startling revelation has resulted in a significant increase in lawsuits against the drug’s manufacturer.
Let’s delve into the role Tepezza plays in causing permanent hearing loss and examine the impact it has had on the medical community.
What is the Tepezza Drug?
Tepezza, a prescription injection developed by Horizon Therapeutics, is used for treating thyroid eye disease (TED) associated with hyperthyroidism and Grave’s disease—an autoimmune condition leading to symptoms like swollen eyes, eye inflammation, and sometimes, bulging eyes.
Given the absence of alternative treatments for these conditions, Tepezza received expedited FDA approval in January 2020, bypassing extensive research from large clinical trial groups to assess the full range of potential side effects and their severity across diverse populations.
Since its release, individuals have reported experiencing hearing issues following Tepezza infusions, encompassing symptoms like ringing in the ears, autophony (a perception of plugged ears), or even complete hearing loss.
As mounting evidence suggests that the drug manufacturers were aware of the risks associated with continuous and regular infusions of Tepezza, individuals are now pursuing settlements through the Tepezza lawsuit. This class-action lawsuit asserts that adequate warnings could have averted permanent hearing damage, benefiting users, regulators, and the medical community had they been provided.
Can Tepezza Cause Permanent Hearing Loss?
Tepezza functions by targeting and obstructing the Insulin-like Growth Factor-1 Receptor (IGF-1R), aiming to alleviate inflammation and swelling associated with TED. However, while suppressing this protein, the drug affects sensory cells crucial for hearing, potentially leading to permanent hearing damage.
A March 2021 study by the Endocrine Society revealed that 65% of regular Tepezza users might encounter hearing issues due to the medication’s adverse effects on the immune system. Additionally, a striking 85% of patients could face permanent hearing loss, ranging from mild to severe.
Researchers attribute these conditions to the adverse effects of teprotumumab, the active ingredient in Tepezza. A report published in the Ophthalmic Plastic and Reconstructive Surgery Journal cautioned that teprotumumab might induce various irreversible hearing loss symptoms that can vary in terms of severity.
Despite this, the Tepezza warning label clarifies that no formal studies assessing the drug’s molecular, biochemical, and physiologic effects have been conducted.
Although Horizon Therapeutics contends that Tepezza side effects generally get resolved within 3 months of stopping the treatment, a 2022 study in the American Journal of Ophthalmology discovered that 55% of Tepezza patients continued to experience hearing loss eight months after stopping infusions.
Due to the limited clinical data from the manufacturer, the number of individuals left with permanent hearing issues because of Tepezza remains largely unknown.
FDA Puts Updated Warning Label on Tepezza
In the case of Tepezza, Horizon Pharmaceuticals didn’t provide adequate warning about the risk of hearing loss and other associated side effects. According to TorHoerman Law, numerous individuals have reported a broad spectrum of hearing loss side effects following Tepezza infusions, encompassing sensorineural hearing loss, heightened sensitivity to sound, a sensation of ear plugging, tinnitus, and more.
While the drug manufacturer acknowledged the possibility of hearing loss during product use, it was inaccurately suggested that any hearing impairment or tinnitus would cease with the conclusion of treatments—a significant misrepresentation of the actual risk.
Initially, before the drug’s market launch, a 10% likelihood of developing otological symptoms was mentioned. However, just after a year of the production of the drug, this percentage surged to over six times the initial likelihood, increasing to 65%.
In July 2023, the FDA approved an updated warning label for Tepezza, now including crucial information in the “Warnings and Precautions” section, emphasizing that Tepezza may cause serious and irreversible hearing loss.
Regrettably, this updated warning has come too late for many previous Tepezza users who now grapple with permanent hearing loss, a consequence of the manufacturer’s failure to disclose the risks of auditory damage.
The link between Tepezza infusions and hearing loss or tinnitus raises substantial concerns for numerous patients. With an increasing number of Tepezza users encountering hearing loss, it is expected that numerous lawsuits related to Tepezza-induced hearing loss will emerge in the future.
Anticipating a rise in plaintiffs and given the severity of the situation, a group of federal judges has opted for Tepezza hearing loss claims to move forward as a multidistrict litigation, despite objections from Horizon Therapeutics.