Tepezza Hearing Loss Lawsuit

What is Tepezza and How Does it Work?

The Unsafe Drug and Medical Device Team at Anapol Weiss is currently investigating Tepezza. Tepezza is an infusion drug therapy indicated for the treatment of Thyroid Eye Disease (“TED”), including conditions also called Graves’ Eye Disease, Graves’ Ophthalmopathy, or Graves’ Orbitopathy. In January of 2020, Tepezza (also known as Teprotumumab), manufactured by Horizon Pharmaceuticals, Inc. (“Horizon”), was approved by the U.S. Food and Drug Administration (“FDA”). It is the first and only drug to be approved for thyroid eye disease.

Tepezza & Hearing Loss – What we Know So Far

Prior to FDA approval, patients in the clinical trials complained of hearing loss and impairment as well as tinnitus (ringing in the ears) following the usage of Tepezza. During the FDA review process, Horizon acknowledged the potential side effects of hearing loss or damage, but characterized it as only as temporary hearing loss, limited in duration and affecting only 10% of the patients. However, a study published in March of 2021 of the Journal Endocrine Society, reported that 65% of patients who took Tepezza, experienced some level of hearing loss, hearing damage, or tinnitus. Moreover, in February of 2022, an observational study published by the American Journal of Ophthalmology, revealed that in 3 out of 5 patients with Tepezza-related hearing loss, there was persistent subjective hearing-loss at their last follow-up appointments, in stark contrast to Horizon’s claim that the hearing impairment was temporary.