Recent studies have raised awareness about the potential risk of irreversible hearing problems associated with Tepezza, a fairly new drug approved by the U.S. Food and Drug Administration (FDA) to treat Thyroid Eye Disease (TED) in adults. According to a number of recent case studies, people who take Tepezza for TED may face a greater risk of hearing loss and other hearing problems that may be irreversible. If you or someone you love has suffered hearing loss, tinnitus, muffled hearing, or another adverse hearing event during or after Tepezza treatment, contact Consumer Safety Watch as soon as possible to find out if you are eligible to file a Tepezza claim for compensation. Tepezza maker Horizon Therapeutics is responsible for the safety of the medication and should be held accountable for any unexpected side effects Tepezza users encounter, including reversible or irreversible hearing loss.
Tepezza (teprotumumab-trbw) is an intravenous infusion drug manufactured by Horizon Therapeutics and it is currently the only FDA-approved medication for Thyroid Eye Disease, a rare but serious autoimmune disease that can cause debilitating, vision-threatening symptoms like eye bulging, double vision, blurred vision, inflammation, pain, and facial disfigurement. Tepezza was approved for use in the United States just over two years ago, and it has already been identified as a potential cause of hearing loss, tinnitus, and other adverse hearing events in users. The medication’s approval was based on the results of two clinical trials consisting of 170 patients with active Thyroid Eye Disease and hearing loss was identified as one of the most common adverse reactions in the Tepezza group, compared to those given a placebo. In phase 2 and 3 trials, 85% of patients treated with Tepezza experienced adverse reactions, 10% of which had to do with hearing loss, compared to 0% in the placebo group.
Since Tepezza’s approval, which was granted via Priority Review, Orphan Drug, Fast Track and Breakthrough Therapy designations from the FDA, there have been multiple reports of the drug causing irreversible hearing loss in users. In February 2022, Horizon announced the results of a post-marketing safety analysis of hearing-related events associated with Tepezza for TED, reporting that 10% of patients on Tepezza experienced hearing loss. “Among the thousands of patients included in this 19-month analysis (Jan. 2020 – Aug. 2021), approximately 10% of all cases reported to the safety database have included a hearing-related event,” Horizon reported in a press release. “The most frequently reported hearing event was hypoacusis (reduction in hearing), followed by tinnitus (ringing in the ears).”
In another study, presented at the annal meeting of The Endocrine Society in 2021, researchers observed a significantly higher rate of adverse hearing events in patients treated with Tepezza. To better understand the potential risk of hearing loss symptoms associated with Tepezza, the researchers in this study followed 28 patients who received at least four infusions of Tepezza at a single institution. They found that 13 (46%) complained of hearing symptoms, the most common being autophony or an ear plugging sensation and hearing loss or muffled hearing. According to this growing body of research, Tepezza users may experience the following adverse hearing symptoms, which may be irreversible:
Horizon has not included any information about adverse hearing events on the Tepezza warning label, which means users likely have no idea that the medication may put them at risk for irreversible hearing loss. For some people, these hearing-related side effects may adversely impact their quality of life and make it difficult for them to perform certain daily living activities. And while it has been suggested that hearing problems potentially linked to Tepezza treatment may resolve upon discontinuation of the drug, the researchers who followed Tepezza patients complaining of hearing symptoms in the 2021 study found that those with documented hearing loss did not experience a significant improvement in their hearing on average three months after stopping the medication. To learn more about the potential risk of hearing loss from Tepezza treatment, contact Consumer Safety Watch today. If you have experienced a hearing-related symptom that you believe to be related to the Thyroid Eye Disease drug Tepezza, you may have grounds to file a Tepezza injury lawsuit against Horizon, which may help you recover compensation for your losses.