Scientific Evidence Supporting Tepezza Hearing Loss Claims

Scientific Evidence Supporting Tepezza Hearing Loss Claims

Tepezza (teprotumumab), a groundbreaking treatment for Thyroid Eye Disease (TED), has offered relief to thousands of individuals suffering from this debilitating condition. Approved by the U.S. Food and Drug Administration (FDA) in 2020, Tepezza works by targeting the insulin-like growth factor-1 receptor (IGF-1R), reducing inflammation and improving eye-related symptoms. However, alongside its benefits, growing concerns have emerged about its potential side effects, particularly hearing loss.

Reports of auditory impairments, including sensorineural hearing loss and tinnitus, have raised questions about whether these risks were adequately disclosed to patients and healthcare providers. As evidence mounts in clinical studies and patient testimonials, litigation surrounding Tepezza has gained traction, with individuals alleging that the manufacturer failed to provide proper warnings.

Have you or a loved one been impacted by Tepezza? Call (888) 984-6195 today, and our team at Lawsuits.com will connect you with a vetted, experienced lawyer in your area who is ready to fight for the justice you deserve.

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Clinical Trials and Initial Findings

Tepezza’s journey to FDA approval involved rigorous clinical trials designed to evaluate its safety and efficacy. However, during these trials, early warning signs emerged regarding its impact on patients' auditory health. While the drug demonstrated remarkable improvements in treating Thyroid Eye Disease, reports of hearing-related side effects were notable enough to warrant further attention.

What the Clinical Trials Revealed

In Phase 2 and Phase 3 trials, approximately 10% of participants reported experiencing some form of otologic (ear-related) symptoms. These included hearing loss, tinnitus (ringing in the ears), and a sensation of fullness or pressure in the ears.

Key Findings From the Trials:

• Sensorineural Hearing Loss: This condition, which affects the inner ear or the nerve pathways to the brain, was among the most commonly reported issues.
• Tinnitus: Participants frequently mentioned persistent ringing or buzzing sounds, even in the absence of external noise.
• Eustachian Tube Dysfunction: Some trial participants described discomfort linked to pressure regulation in the middle ear, often manifesting as muffled hearing.

Why These Findings Matter

Although clinical trials are conducted to assess potential risks, these auditory symptoms were initially classified as relatively rare. This impacts a concept known as informed consent, which requires that patients be fully informed of the known risks associated with a medical treatment before agreeing to it. 

When risks like hearing loss are underrepresented or omitted, patients cannot make educated decisions about their care, potentially leading to avoidable harm. For many Tepezza users, the lack of clear warnings may have left them unprepared for the possibility of long-term or permanent hearing impairment, raising serious ethical and legal concerns about whether their consent was truly informed.

Post-Marketing Surveillance and Subsequent Studies

After Tepezza entered the market, its broader use revealed an increasing number of reports of hearing-related side effects, far exceeding the initial estimates from clinical trials. Post-marketing surveillance, conducted through patient-reported outcomes, clinician observations, and independent research studies, highlighted a concerning pattern that has since led to heightened scrutiny.

Significant Findings From Post-Marketing Studies

ENDO 2021 Research Presentation

At the Endocrine Society’s 2021 annual meeting, researchers unveiled findings that painted a starkly different picture from the clinical trials. Their small-scale study revealed that 65% of patients treated with Tepezza experienced auditory symptoms, including:

• Muffled hearing.
• Persistent tinnitus.
• Partial or complete hearing loss.

Journal of Endocrine Practice Study

In a more extensive analysis involving 121 patients, 16% reported auditory complications, including:

• Sensorineural hearing loss—a condition involving irreversible damage to the auditory nerve or inner ear structures.
• Tinnitus and Eustachian tube dysfunction, leading to a diminished ability to hear and regulate ear pressure.

These findings sparked renewed concerns among healthcare providers and regulatory bodies about the adequacy of Tepezza’s safety profile.

Patterns Emerging From Patient Reports

Patients who experienced auditory side effects often noted that symptoms persisted long after their Tepezza treatment ended. Some described a progressive worsening of hearing loss, raising questions about whether the damage caused by the drug could be permanent.

• Common Onset: Symptoms typically emerged during or shortly after the second infusion.
• Lack of Resolution: For many patients, discontinuing the drug did not lead to the resolution of hearing issues.

Role of Post-Marketing Surveillance Laws

Under federal law, particularly 21 C.F.R. § 314.80, pharmaceutical manufacturers are required to monitor and report adverse drug reactions once a medication is on the market. This statute ensures that regulators, healthcare providers, and patients remain informed of emerging risks. Litigation surrounding Tepezza often alleges that the manufacturer failed to comply fully with these requirements, delaying necessary label updates and public warnings.

FDA Response and Label Updates

The mounting evidence linking Tepezza to hearing-related side effects prompted the U.S. Food and Drug Administration (FDA) to take regulatory action. In 2023, the FDA issued updated guidance for healthcare providers and mandated revisions to Tepezza’s warning labels, highlighting the risks of hearing impairment. These measures were intended to ensure that patients and physicians could make fully informed decisions about the drug's use.

Updated Warning Label Requirements

The FDA’s revised label now includes explicit warnings about the potential for hearing loss and other auditory impairments. The key updates address:

• Sensorineural Hearing Loss: Highlighting the risk of damage to the auditory nerve or inner ear structures.
• Tinnitus: Identified as a persistent and common side effect in post-marketing surveillance.
• Eustachian Tube Dysfunction: Acknowledging complaints of muffled hearing and ear fullness.

Issuance of Healthcare Provider Guidance

Alongside the label updates, the FDA released specific guidance to healthcare providers, urging them to:

• Conduct baseline audiometric testing before initiating Tepezza treatment.
• Monitor for auditory symptoms during and after treatment.
• Educate patients about the potential risks of hearing loss and emphasize the importance of reporting symptoms promptly.

Mechanism of Action and Potential Causes of Hearing Loss

Tepezza’s ability to treat Thyroid Eye Disease (TED) lies in its unique mechanism of action: it targets and inhibits the insulin-like growth factor-1 receptor (IGF-1R). While this receptor plays a key role in reducing inflammation and halting the progression of TED, its inhibition may also disrupt other physiological processes, including auditory function.

IGF-1R and Its Role in Auditory Health

IGF-1R Function in the Body

• IGF-1R is a protein found on the surface of many cell types, including those in the inner ear.
• It regulates cellular growth, repair, and survival.
• In the ear, IGF-1R signaling supports the health of hair cells and auditory nerve pathways essential for normal hearing.

How Tepezza Affects IGF-1R

• By inhibiting IGF-1R, Tepezza may interfere with these processes.
• This disruption can lead to damage in the cochlea (the inner ear structure responsible for translating sound into nerve signals) or impair the ability of auditory cells to repair themselves.

Hypothesized Mechanisms of Hearing Damage

1. Hair Cell Damage in the Cochlea

• The cochlea contains sensory hair cells that detect sound waves and convert them into electrical signals for the brain.
• IGF-1R inhibition may lead to degeneration or dysfunction of these cells, resulting in sensorineural hearing loss.

2. Inflammation in Auditory Pathways

• While Tepezza reduces inflammation in the tissues around the eyes, it could trigger unintended inflammatory responses in the auditory system.
• Such inflammation may cause tinnitus, a persistent ringing or buzzing sound in the ears.

3. Eustachian Tube Dysfunction

• IGF-1R signaling also affects the Eustachian tube, which regulates air pressure and fluid in the middle ear.
• Disruption in this system may explain the feeling of ear fullness or muffled hearing reported by some patients.

Supporting Scientific Evidence

Several independent studies support these theories:

• Animal Models of IGF-1 Inhibition: Research has shown that disrupting IGF-1 signaling in mice led to hair cell degeneration and progressive hearing loss.
• Clinical Observations in Human Subjects: Patients treated with IGF-1 inhibitors, including Tepezza, reported auditory symptoms consistent with sensorineural hearing loss.

The Importance of Further Research

Although these mechanisms are not yet fully understood, existing evidence has already established a strong causal link between Tepezza and hearing loss. This is enough to establish a solid foundation for legal action.

While further research is necessary to deepen our understanding of how Tepezza affects auditory health, what is already known underscores the need for accountability. Additional studies will refine patient care practices, guide regulatory decisions, and strengthen the body of evidence supporting plaintiffs in ongoing litigation.

Legal Implications and Ongoing Litigation

As evidence of Tepezza’s connection to hearing loss grows, patients who have experienced auditory side effects are pursuing legal action. The lawsuits allege that the drug’s manufacturer failed to adequately warn patients and healthcare providers of the risks associated with the medication, leading to preventable harm.

Basis for Legal Claims

1. Failure to Warn

Under laws governing product liability, manufacturers have a duty to disclose known risks associated with their drugs. Plaintiffs in Tepezza lawsuits argue that the initial warning labels and marketing materials did not sufficiently highlight the risk of hearing loss, leaving patients unable to make informed decisions.

2. Negligence in Post-Marketing Surveillance

Plaintiffs claim that the manufacturer did not act promptly to investigate and disclose reports of hearing loss, violating FDA regulations under 21 C.F.R. § 314.80, which requires ongoing reporting and evaluation of adverse events.

3. Breach of Warranty

Patients argue that Tepezza was marketed as a safe and effective treatment without adequately disclosing risks, violating both express and implied warranties of safety.

Consolidation of Cases: Multidistrict Litigation (MDL)

In August 2023, the U.S. Judicial Panel on Multidistrict Litigation (JPML) consolidated lawsuits related to Tepezza hearing loss into an MDL in the U.S. District Court for the Northern District of Illinois. MDL centralization streamlines pretrial proceedings and allows plaintiffs to share resources while pursuing individual claims.

As of the end of 2024, there are over 150+ lawsuits that have been filed and consolidated.

Read our article: How to file a lawsuit for Tepezza injuries

Compensation Sought by Plaintiffs

Victims of Tepezza-induced hearing loss are seeking compensation for:

• Medical Expenses: Costs for audiological evaluations, hearing aids, or cochlear implants.
• Lost Wages: Income lost due to work absences or diminished job opportunities resulting from hearing impairment.
• Pain and Suffering: Emotional distress caused by permanent or progressive hearing loss.

Recommendations for Patients

1. Monitor and Document Symptoms

Patients should pay close attention to any changes in their hearing during or after treatment with Tepezza. Symptoms to monitor include:

• Muffled or diminished hearing.
• Ringing or buzzing (tinnitus).
• A feeling of fullness or fluid in the ears.

Keep a detailed log of:

• When symptoms first appeared.
• How they have progressed over time.
• Any medical evaluations or treatments received.

This documentation can serve as evidence in both medical consultations and legal claims.

2. Seek Immediate Medical Attention

If you notice hearing issues, consult an audiologist or otolaryngologist (ear, nose, and throat specialist) promptly. Early diagnosis and treatment may improve outcomes and provide clarity on the cause of your symptoms.

• Request audiometric testing to establish a baseline of your auditory health.
• Follow up with regular evaluations if you continue using Tepezza or experience lingering symptoms.

3. Consult With Legal Counsel

If you believe your hearing loss is linked to Tepezza, reach out to us and we will connect you with an experienced product liability attorney. They will help you:

• Understand your legal rights and options.
• Determine whether your case qualifies for participation in ongoing litigation, such as the MDL.
• Pursue compensation for medical costs, lost wages, and emotional distress.

Find Justice for Tepezza-Related Hearing Loss

If you’ve experienced hearing loss, tinnitus, or other auditory impairments after using Tepezza, you’re not alone. The scientific evidence is clear, and countless patients are now stepping forward to hold the manufacturer accountable. Call (888) 984-6195 now to get started. Let us connect you with an experienced attorney in our network who is ready to fight for your future.