Tepezza Hearing Loss

Tepezza, is also known as teprotumumab, is the first FDA-approved drug for treating thyroid eye disease, but according to patients, it causes serious hearing loss.

Tepezza is made by an Irish company called Horizon Therapeutics, based in Dublin, Ireland. According to some patients who have taken Tepezza, they have reported various hearing problems, including increased sensitivity to sound, persistent ringing in the ears, known as tinnitus, temporary and permanent hearing loss, and much more.

What Is Thyroid Eye Disease?

Thyroid Eye Disease (TED), also known as Graves’ orbitopathy or Graves’ ophthalmopathy, is an autoimmune condition that affects the muscles and other tissues around the eyes. It is most commonly associated with Graves’ disease, an autoimmune disorder that leads to overactivity of the thyroid gland (hyperthyroidism). However, TED can also occur in individuals with normal thyroid function or hypothyroidism.

The exact cause of TED is not fully understood, but it involves the immune system attacking the tissues around the eyes, leading to inflammation and swelling. This can cause several symptoms, including:

Bulging Eyes (Proptosis): The swelling can push the eyeball forward, making it appear as though the eyes are bulging out.
Swelling and Redness: Eyelids and tissues around the eyes can become swollen and red.
Double Vision (Diplopia): Muscle swelling may affect eye movement, leading to misalignment and double vision.
Dry Eyes or Excessive Tearing: Changes in eyelid position or swelling can lead to dry eyes or excessive tearing.
Pain and Discomfort: There can be pain in and around the eyes, especially with movement.
Vision Problems: In severe cases, the swelling can compress the optic nerve, potentially leading to vision loss.

TED is more common in women than in men and typically occurs in middle age. The course of the disease can vary; some individuals may experience mild symptoms, while others may have severe, vision-threatening complications.

Treatment for TED aims to manage symptoms and may include lubricating eye drops, selenium supplements, corticosteroids to reduce inflammation, and in some cases, surgery to correct severe eye problems. In recent years, new treatments targeting the underlying autoimmune processes, such as Tepezza, have been approved for management of the condition.

TED is a relatively rare condition, but it is the most common cause of proptosis or bulging of the eye and orbital disease in adults. The prevalence of TED among individuals with Graves’ disease, which is the most common cause of hyperthyroidism, provides some insight into its commonality. Approximately 25-50% of people with Graves’ disease will develop some form of TED, although the severity and symptoms can vary widely from mild to severe.

How common is Thyroid Eye Disease?

The incidence of TED in the general population is harder to pinpoint due to the variability of the disease and underdiagnosis in milder cases. Studies suggest that the annual incidence rate of TED is around 16 cases per 100,000 women and 3 cases per 100,000 men, highlighting a higher prevalence among females. However, these figures can vary depending on the population studied and the diagnostic criteria used.

TED is most commonly observed in individuals between the ages of 40 and 49 for women and 60 and 69 for men, although it can occur at any age. Smoking is a significant risk factor that increases both the risk and severity of TED among individuals with Graves’ disease.

While TED is relatively rare in the general population, its impact on those affected can be significant, leading to visual impairment, cosmetic concerns, and a reduced quality of life, underscoring the importance of early diagnosis and management.

In 2019, Horizon Therapeutics reported promising results from Tepezza clinical trials. The FDA approved the drug a few months later. Tepezza works by decreasing inflammation and blocking the IGF-1R receptor, which reduces muscle and tissue swelling. Tepezza patients receive an intravenous injection once every three weeks. Treatment consists of eight injections, so it takes about five to six months for patients to complete treatment.

Tepezza Medical Studies

More patients than previously reported may experience hearing symptoms such as hearing loss or muffled hearing from a new treatment for thyroid eye disease, Tepezza, according to a small study presented at ENDO 2021, the Endocrine Society’s annual meeting.

Tepezza Lawsuits

Tepezza was accelerated through the FDA approval process in January 2020, without in-depth research from big clinical trial groups to investigate all of the potential side effects and their seriousness among different groups.

Tepezza lawsuits are being filed on behalf of people who have suffered hearing injuries after using the drug. Tepezza hearing loss lawsuits are being filed because plaintiffs allege that Horizon Therapeutics failed to warn doctors and patients about the risk of permanent hearing loss and tinnitus. While Horizon Therapeutics noted that there was a 10% risk of hearing problems discovered during clinical trials, studies have found that up to 65% of patients have developed new, worsening or permanent hearing problems.

Plaintiffs also claim that the company failed to adequately test Tepezza before its release to the public, suggesting that Tepezza was defective even before it was approved. Despite the hearing problems health risks, there has been no recall of Tepezza.

Tepezza Federal MDL Consolidation

Tepezza hearing loss multidistrict litigation (MDL) is centralized before U.S. District Judge Thomas Durkin in the Northern District of Illinois for coordinated pretrial proceedings. As of February 2024, there are a total of 74 Tepezza Lawsuits pending according to the most recent JPML filings.

Tepezza Lawsuits are consolidated into multidistrict litigation (MDL) under MDL 3079: Tepezza Marketing, Sales Practices, and Products Liability Litigation. MDLs are designed to streamline the litigation process by centralizing the discovery process, and because there is only one judge overseeing the whole process, this ensures consistent rulings on key legal issues.

How does Tepezza cause Hearing Loss?

Tepezza can cause hearing loss by blocking a protein Insulin-like Growth Factor-1 Receptor, IGF-1R, which plays an important role in the growth and maintenance of the sensory cells responsible for transmitting sound waves in the inner ear. By blocking this protein, the sensory cells are affected that are essential for hearing, which can lead to permanent cell damage and the onset of hearing problems. The IGF-IR receptor protects inner ear
hair cells from hearing damage caused by noise.

Lower levels of IGF-1R have been associated with severe hearing loss. A 2021 study found that 65% of patients reported hearing problems after starting Tepezza. In another report found that up to 81.5% of thyroid eye disease patients taking the drug reported auditory symptoms halfway through treatment.

Tepezza side effects include permanent hearing loss, hyperacusis (increased sensitivity to certain sounds), tinnitus (persistent ringing in the ears), eustachian tube dysfunction (fluid in the ears), and autophony (hearing one’s own voice as overly loud).

Can Tepezza hearing loss be permanent?

Hearing loss from Tepezza can be both temporary and permanent. Some patients’ symptoms improve a few months after stopping the drug, while others continue to experience symptoms even after discontinuing treatment.

One case study from British Medical Journal BMJ, reports that a woman in her 50s started Tepezza after being diagnosed with chronic thyroid eye disease. She developed tinnitus after her third dose and reported hearing loss after her fifth treatment. A hearing test showed mild to moderate-severe hearing loss in both ears.

The woman stopped taking Tepezza, but a follow-up hearing test showed no improvement. There is significant evidence that Tepezza-induced hearing loss is irreversible in some cases.

According to the BMJ article, this case describes a patient who objectively developed chronic sensorineural hearing loss after partial Tepezza therapy for the treatment of thyroid eye disease.

Tepezza is a biological agent that inhibits the IGF-1 pathway by targeting the IGF-1R. IGF-1 is a neuroprotective agent that regulates the development and maintenance of the inner ear. It participates in cellular metabolism, growth, proliferation, differentiation and prevention of cell death of hair cells. IGF-1 deficiency is associated with profound sensorineural hearing loss in mice models and humans.

New FDA Warning

The FDA issued an updated Tepezza prescribing information guide on July 20, 2023, adding new warnings about the potential risk of permanent hearing loss from Tepezza. In the guideline, the FDA instructs doctors to evaluate patients’ hearing before, during, and after the use of Tepezza, and warn that Tepezza can cause severe hearing impairment.