A new medication for thyroid eye disease, widely hailed as a wonder drug upon its release, has been linked to serious hearing problems, including tinnitus and permanent hearing loss.
Thyroid eye disease (TED), although rare, is a progressive and often excruciating condition that can lead to complete blindness. In 2020, a global pharmaceutical company called Horizon Therapeutics released Tepezza, the first FDA-approved treatment for TED. Before Tepezza, patients’ only options to ease their symptoms were cancer medications like rituximab, steroids such as prednisone, or surgery.
Unfortunately, many hopeful patients who tried Tepezza quickly began experiencing hearing problems ranging from mild to severe. Some patients’ symptoms cleared up when they stopped taking the drug; others had symptoms persist long after.
People are now filing Tepezza lawsuits against Horizon, claiming that the manufacturer not only failed to warn doctors and patients that the drug might cause hearing problems but did not test it adequately before its release, resulting in a defective product being sold to the public.
Tepezza has not yet been recalled, despite these lawsuits and several scientific studies showing a clear link to tinnitus and/or hearing loss.
Many Tepezza cases have been consolidated into multidistrict litigation (MDL) in the Northern District of Illinois to streamline discovery proceedings. More are expected in the following months. Patients who develop hearing problems after using Tepezza may be eligible for financial compensation and should contact a qualified Tepezza product liability attorney.
What Is Thyroid Eye Disease (TED)?
The thyroid gland is a small organ located at the front of the neck that releases thyroid hormone, which helps perform many functions in the body. It can sometimes release too much or too little thyroid hormone, causing complications in muscle strength, and bowel or heart function.
Thyroid eye disease is a complication that results in swelling and inflammation around the eyes. Symptoms include blurred vision, pain or pressure behind the eye, and eyes that feel gritty, are bulging or difficult to close, too wet or dry, and sensitive to light. As many as half a million Americans have TED – especially those with Graves’ disease, an autoimmune disorder characterized by hyperthyroidism.
Doctors and patients were excited about Tepezza’s release because it offered a non-surgical treatment option for TED.
Does Tepezza Cause Hearing Loss?
Tepezza is administered intravenously via eight infusion treatments given once every three weeks and works by blocking the IGF-1R receptor, which reduces tissue and muscle swelling. While TED patients have found significant relief after using Tepezza, they weren’t prepared for the side effects of lower IGF-1R levels.
These insulin-like growth factor receptors are vital for protecting and maintaining healthy hearing. Lowering them leads to symptoms such as muffled hearing, increased sensitivity to sound, hearing your own voice echoing in your ear (autophony), liquid in the ears, and temporary or permanent hearing loss.
Tepezza’s medication label initially had no warning of these risks. It wasn’t until July 2023 – more than a year after the first lawsuit was filed – that the FDA updated the label to include them.
In a 2022 press release addressing Tepezza’s hearing loss issues, Horizon said their clinical trials prior to its release found auditory complications in just 10 percent of patients, most of which were “mild to moderate” and reversible.
However, a 2021 study presented at the annual meeting of the Endocrine Society found that the rate could be as high as 65 percent. Other findings from independent studies on Tepezza include:
- A woman in her 50s developed tinnitus after just three doses of Tepezza and hearing loss after five, with no improvement shown after discontinuing.
- A 2022 study from the American Journal of Ophthalmology found that 81.5 percent of participants developed new hearing problems after an average of 3.8 Tepezza infusions.
- 2023 research on a link between thyroid conditions and hearing loss claims found that 32 percent of Tepezza users had claims related to medication-caused hearing problems, other ear injuries, and congenital abnormalities.
If you have thyroid eye disease, you’ve likely seen Tepezza TV commercials hailing the arrival of this “wonder drug.” These advertisements typically do not mention the risk of hearing problems associated with Tepezza nor how expensive the drug is. The price for one year of treatment can be more than $300,000, with no guarantee of insurance coverage.
Some alternatives to Tepezza may be worth exploring for TED, including selenium supplements, other medications, and lifestyle changes such as quitting smoking and eating a healthier diet. Mild cases may be treated with eye drops, eye patches, or dark sunglasses. The best way to determine how to treat TED is by consulting a doctor.