As the only treatment available for these conditions, Tepezza was fast-tracked through the FDA approval process in January 2020. However, the expedited approval left gaps in research, as the drug was not tested in large or diverse clinical trial groups to fully assess the severity and range of potential side effects, most notably, permanent hearing loss and tinnitus.
Although the manufacturer initially disclosed a 10% risk of hearing issues during clinical trials. However, researchers from Stanford University revealed in a 2021 in a virtual meeting at the annual The Endocrine Society that up to 65% of patients experienced new, worsening, or permanent hearing problems after using the drug. A later study published in February 2022, found that 55% of patients with hearing loss continued even eight months after stopping injections.
Since its release, many patients have reported significant hearing issues after receiving Tepezza infusions. These include ringing in the ears (tinnitus), autophony (a condition where internal sounds, like one’s own voice, are unusually loud), a plugged-ear sensation, and total hearing loss.
FDA Update
In July 2023 the FDA issued an update to Tepezza prescribing information guide adding warning about permanent hearing loss
MDL
Northern District of Illinois, Judge Thomas M. Durkin
Litigation Update
There are currently approximately 200 cases filed in the MDL. Four bellwether cases will be selected in January 2025. The close of discovery is currently slated for April 2025 with the first bellwether trial set to take place in March 2026.
Important Links
- https://www.endocrine.org/news-and-advocacy/news-room/featured-science-from-endo-2021/increased-risk-of-hearing-impairment-with-new-thyroid-eye-disease-treatment
- https://www.ajo.com/article/S0002-9394(22)00073-3/abstract#%20