Tepezza infusion treatment has a far greater impact on hearing than initially warned by the drug's manufacturer.
Labeled with hearing loss risks for about 10% of the patients using it, as shown in studies conducted after the drug was approved by the FDA, Tepezza has a significantly higher rate of hearing-related health risks, occurring in up to 65% percent of Tepezza users.
Thyroid eye disease, often also mentioned as Grave's eye disease, is a rare autoimmune disorder associated with the hyperactivity of the thyroid gland, characterized by the inflammation and scarring of the eye muscles and fatty tissue behind the eyes. Signs and symptoms of TED include:
Up until January 2020 when Tepezza infusion treatment was approved by the U.S. Food and Drug Administration, there was no approved treatment for TED. Tepezza appeared on the pharmaceutical market as a promising new drug that could offer relief for patients challenged by TED-associated health issues. One round of Tepezza treatment involves eight Tepezza IV infusions, administered once every three weeks.
January 2020: the FDA approves Tepezza manufactured by Horizon Pharmaceuticals (also known as Horizon Therapeutics) for the treatment of thyroid eye disease and gives it an "orphan status" drug. The documentation submitted for approval by the manufacturer contains, among others, data from two clinical trials conducted by the manufacturer. According to these clinical trials, the risk of hearing loss or tinnitus as an adverse effect of treatment with Tepezza infusion is no higher than 10%. Also, these clinical trials find the auditory side effects of the drug to be mild and reversible.
January 2021: a small study conducted by a group of Stanford University researchers (and led by Andrea Lora Kossler, M.D., assistant professor of ophthalmology at the Stanford University School of Medicine) is presented at the annual meeting of the Endocrine Society (ENDO 2021). The findings of the study show a more than six times higher rate of hearing-related high risks associated with the use of Tepezza infusion treatment, as opposed to the 10% occurrence risk the manufacturer warned about. According to this study, as much as 65% percent of the patients treated with the drug are at risk of developing one or more otologic symptoms. Moreover, these symptoms are not all mild and not all reversible. For some of the symptoms, there was no improvement at all in the 3-month follow-up period after the last infusion was administered.
February 2022: a newer study published in the American Journal of Ophthalmology finds that hearing loss issues associated with the use of Tepezza infusion as a treatment for TED could reach as high as 81.5%. Out of 27 patients participating in this study, new otologic symptoms occurred in 22 patients. Just as in the case of the Stanford University study, symptoms persisted even after the Tepezza infusion treatment was concluded.
January 2023: several Tepezza lawsuits are included in a motion filed for consolidation into Multidistrict Litigation (MDL) in the US District Court, Northern District of Illinois.
Partial or permanent hearing loss, tinnitus, and other auditory symptoms are among the adverse effects that Tepezza infusions may have in patients using the drug for the treatment of thyroid eye disease (TED).
According to the small Stanford University study mentioned above, a total of 65% of the patients participating in the study complained of hearing issues. The most commonly experienced symptoms included:
Symptoms were found to develop after an average of 3.6 Tepezza infusions, but hearing issues may also occur after one single infusion. Some of the otologic symptoms persisted even after the follow-up period observed during the study, which shows that not all of the hearing loss symptoms are reversible, as the manufacturer suggested them to be.
The February 2022 study revealed similar findings regarding hearing loss issues associated with Tepezza infusions, only that the risk of occurrence was found to be even higher (up to 81.5%).
Permanent hearing loss is a major health injury with a significant negative impact on the quality of life. Being able to find relief concerning health issues associated with TED can be, of course, a liberating feeling, but if this comes at the price of having to live with the consequences of impaired hearing for life, then that is too high of a price to pay. If the patient has opted for the Tepezza treatment unaware of the high hearing loss risks associated with its use because the manufacturer failed to fulfill its responsibility to adequately inform and warn about these health risks, then the patient might be entitled to compensation from the manufacturer.
Additional hearing-related adverse effects that might occur as a result of Tepezza infusion treatment for TED include:
If you have received at least one Tepezza infusion and fulfill the two preliminary requirements below, you may qualify for filing a Tepezza claim:
Our team at Atraxia Law is working closely together with experienced attorneys. Equipped with the knowledge accumulated over 35 years in handling defective drug claims, we can pass your case to the attorney that will get the highest legally possible compensation for the health injuries you suffer from.
Contact us, and one of our case managers will quickly and efficiently determine whether or not you are eligible to file a Tepezza claim.