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Tepezza Infusions Linked to Permanent Hearing Loss and Tinnitus

  • April 12, 2023
  • kbaattorneystg
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This is an information piece. No one should stop medical treatment based on this information herein. Instead, consult qualified healthcare providers, which we are not.

This is an informational piece on Tepezza. It is a prescribed for Thyroid Eye Disease. Recent data links it to hearing loss and tinnitus. Studies have found that Tepezza may carry a higher risk of adverse events including of hearing loss and tinnitus.

What is Thyroid Eye Disease?

Thyroid Eye Disease (TED) is an autoimmune disorder. It causes inflammation and damage to the tissues around the eye, “including muscles, fatty tissue and connective tissue.” TED occurs in two main phases, “the active or inflammatory phase and the stable phase. The active phase can last for months up to three years, while the stable phase follows when the inflammation stops.”

Individuals with TED may also have Graves’ disease, another autoimmune condition affecting the thyroid, eyes, and skin. Graves’ disease can result in hyperthyroidism, a disorder that involves thyroid hormone overproduction. While having Graves’ disease or hyperthyroidism does not necessarily result in developing TED, the Cleveland Clinic notes, “anyone can get thyroid eye disease, but it’s more likely if you have a thyroid condition or Graves’ disease.”

TED diagnoses are most common in individuals assigned female at birth. Age forty-three is the median for diagnosis. TED presents a variety of symptoms, such as dry, red, bulging eyes, double vision, and pain with eye movements. The British Thyroid Foundation estimates that Thyroid Eye Disease affects nearly 50,000 people in the U.K. and hundreds of thousands worldwide.

Treatment options vary depending on the extent of symptoms and medical providers’ recommendations. The main treatments include prescription anti-inflammatory drugs, eye drops, eyelid surgery, eye muscle surgery, orbital decompression surgery, lifestyle changes, and or Tepezza infusions. You should always seek the guidance of a licensed medical provider when seeking treatment for health conditions.

Post-Market Risks Associated with Tepezza 

The Tepezza product is the only one we found designed to treat TED. The U.S. Food and Drug Administration approved it for sale in the U.S. in January 2020. Since then, individuals who received Tepezza infusions have reported adverse events. These include partial or permanent hearing loss and tinnitus during and even after treatment.

Initial clinical trials found hearing problems in 10% of patients. Recent studies indicate that the rate could be as high as 81! A study published in the National Library of Medicine found that out of the 27 patients analyzed, “twenty-two patients (81.5%) developed new subjective otologic symptoms, after a mean of 3.8 infusions.” Most of the patients experiencing tinnitus, ear plugging/fullness, and autophony (an enhanced perception of bodily sounds, typically the patient’s own voice and breathing) had their symptoms cease after their last infusion. However, for patients that developed symptoms of hearing loss or decreased word comprehension, only 45.5 percent had symptom resolution after the final infusion.

In March of 2021, the Endocrine Society reported that a study by Andrea Lora Kossler, M.D. and her research team. It found that out of “twenty-six patients with at least four infusions of the drug, seventeen patients (65 percent) complained of otologic symptoms when questioned.” The study also notes, “of the 17 patients with new hearing symptoms, four had new or worsening sensorineural hearing loss, a type resulting from damaged hair cells in the inner ear.” Additionally, three patients suffered from patulous eustachian tube, a disorder in which the eustachian tubes remain open.

Injured Parties Are Filing Lawsuits 

In August of 2022, a Plaintiff filed a lawsuit against Horizon Therapeutics. Plaintiff alleges the company failed to warn of hearing loss and tinnitus as a risk. Additionally, even after recommendations from multiple research studies, there are no additional monitoring guidelines at this time. “In clinical trials, hearing loss was noted as a side effect in 7 to 12% of patients, but no formal audiometric investigations of these patients were reported. Furthermore, the FDA and manufacturer offer no formal guidelines for audiometric monitoring.”

KBA is Here to Help

We do not advocate stopping medical treatment without speaking with a medical provider. For legal advice, licensed attorneys, such as those at KBA Attorneys, have decades of experience navigating the complexities of product liability claims.

If you or a loved one suffered an adverse auditory reaction after using Tepezza, contact us. To learn more about our team and how we might be able to help you, contact our office by clicking here..