Tepezza and Hearing Problems

Tepezza (teprotumumab-trbw) is an FDA approved therapy used to treat Graves Disease, which is a rare and serious autoimmune disease that causes soft tissue inflammation and swelling around the eyes.

In March 2021, the U.S. Food and Drug Administration (FDA) issued a safety communication about hearing loss and balance disorders linked to the use of Tepezza, indicating there have been multiple cases of hearing loss and/or tinnitus (ringing in the ears) reported among patients receiving Tepezza.

After a growing number of hearing damage lawsuits had been filed against the manufacturer, Horizon Therapeutics ultimately revised the cautionary labeling of Tepezza in July 2023, acknowledging that Tepezza side effects may cause severe hearing impairment, which can be permanent in some cases.

The U.S. Food and Drug Administration (FDA) endorsed the updated Tepezza drug label warning, which now explicitly instructs healthcare providers to monitor patients for hearing problems before, during and after treatment.

While the exact way that Tepezza causes hearing problems is still being investigated by independent researchers, it is believed that the inhibition of IGF-1R by Tepezza may affect the labyrinth of the ear, which is the part of the ear that contains organs of the senses of hearing and equilibrium.

The drug maker knew or should have known about this risk before the drug was ever introduced. If warnings about the risk of hearing loss from Tepezza side effects had been disclosed when the drug was released, many individuals could have avoided permanent hearing damage.

Can Tepezza cause hearing loss?

Yes, Tepezza can cause hearing loss. While Tepezza was advertised with only a 10% risk of temporary hearing problems loss, studies have shown real world Tepezza hearing loss rates are as high as 65% and 82%.

Studies Linking Tepezza and Hearing Loss

Multiple independent studies, including clinical trials, case reports, and peer-reviewed journal articles have established a strong link between Tepezza hearing problems, raising serious concerns about Horizon Therapeutics’ previously reported safety profile of the drug.

Tepezza Linked to Hearing Complications

Just over a year after Tepezza received FDA approval for the treatment of Graves disease, the findings of a study titled, Hearing Loss and Teprotumumab, were presented at the Endocrine Society’s annual meeting in 2021. The study revealed 65% of patients treated with teprotumumab (Tepezza) for thyroid eye disease experienced some form of hearing side effects.

While the number of individuals included in the study was only about one-third of that in Tepezza clinical trials, researchers identified a significant amount of new hearing impairment reports have been reported after receiving only four Tepezza infusions, finding;

• 65% developed new hearing problems
• 23% reported suffering hearing loss
• 27% developed tinnitus
• 12% reported ear plugging symptoms
• 29% said they developed autophony

Permanency of Tepezza Hearing Loss

Despite the manufacturer’s claim that Tepezza side effects would resolve within three months of stopping infusions, a study published in the American Journal of Ophthalmology in February 2022 found otherwise.

Researchers looked at data on 27 individuals who received at least 4 Tepezza infusions. The study looked for new hearing impairment or worsening otologic symptoms after 2, 4, and 8 Tepezza fusions at 8-month follow-up.

Researchers reported 81.5% of Tepezza patients developed new subjective hearing symptoms, after a mean of 3.8 infusions.

When analyzing symptom resolution rates of Tepezza side effects, researchers found that after eight months of stopping Tepezza infusions,

• 55% of Tepezza recipients still suffered from subjective hearing loss/worsening sensorineural hearing loss/decreased word comprehension
• Nearly 20% of patients still suffered from autophony
• Almost 10% of patients still suffered earplugging sensation symptoms

“Hearing loss is a concerning adverse event of teprotumumab (Tepezza), and its mechanism and reversibility should be further studied. Until risk factors for hearing loss are better understood, we recommend baseline audiometry with PET testing and repeat testing if new otologic symptoms develop. Screening, monitoring, and prevention guidelines are needed.”

How does Tepezza cause hearing loss side effects?

The thyroid eye disease drug Tepezza blocks a protein called IGF-1R that can damage hair cells responsible for hearing and balance, as well as disrupting middle and inner ear structures that can lead to hearing loss and tinnitus.

IGF-1R is believed to play a role in regulating the growth, development, and maintenance of hair cells in the ear. By blocking this protein it dulls the sensory cells that are responsible for detecting sound waves and transmitting them to the brain. Hair cells are essential for hearing, and damage or loss of these cells can lead to hearing loss and other auditory problems.

Tepezza can also cause a condition called Patulous Eustachian tube. Patulous eustachian tube is a rare condition where the eustachian tube, which connects the middle ear to the back of the throat, remains open, causing symptoms like autophony (hearing one’s own breathing and voice loudly), aural fullness, and ear pain.

The drug Tepezza has been found to cause the Patulous Eustachian tube condition as a side effect in some patients by increasing inflammation and fluid buildup in the eustachian tube.

What types of hearing loss can Tepezza cause?

Tepezza has been linked to multiple forms of auditory impairments that can range from complete loss of hearing to constant and debilitating tones. Some of the most commonly reported new hearing symptoms after Tepezza have included;

• Hearing loss
• Tinnitus
• Autophony
• Ear Plugging

Sensorineural Hearing loss from Tepezza

Sensorineural hearing loss (SNHL) is a specific type of hearing loss caused by damage to the hair cells in the ear (cochlea) or the auditory nerve, which carries sound signals from the ear to the brain.

Here is a list of sensorineural hearing loss symptoms that have been reported from people taking Tepezza:

• Difficulty hearing in noisy environments: People with SNHL from Tepezza often have trouble distinguishing speech or other sounds in noisy places, as the damaged hair cells or auditory nerve struggle to process sound information correctly.
• Muffled sounds or speech: SNHL can cause sounds to seem muffled or unclear, making it challenging to understand speech or identify specific sounds..
• Trouble understanding high-pitched sounds or voices: High-frequency hearing loss is common in Tepezza users, leading to difficulties in hearing high-pitched sounds like women’s and children’s voices or musical notes.
• Difficulty hearing over background noise: SNHL may make it challenging to hear and understand speech over background noises especially on phone calls or video conferencing where sound quality is not the best.
• Unusually loud hearing in one ear.

Tinnitus from Tepezza

Tinnitus is a type of hearing impairment that is often described as a ringing, buzzing, hissing, or whistling sound in the ears or head. Tinnitus can be temporary or chronic and can affect people of all ages.

The symptoms of tinnitus caused by Tepezza infusions can vary from person to person, but individuals have commonly reported;

• Ringing, buzzing, hissing, or whistling sounds in the ears or head.
• The perception of sound that is not present in the environment.
• The sound may be constant or intermittent.
• The sound may be high-pitched or low-pitched.
• Difficulty sleeping due to the noise.
• Difficulty concentrating due to the noise.

Autophony and Tepezza

Autophony is a medical condition characterized by hearing one’s own voice or other self-generated sounds too loudly or too clearly. It is also referred to as echo in the ear, and it can be an uncomfortable and distressing experience for those who suffer from it.

Autophony from Tepezza can cause individuals to experience the following symptoms:

• Hearing one’s own voice or breathing too loudly or too clearly.
• Feeling like one’s own voice is echoing in the ear.
• Hearing other self-generated sounds, such as chewing or swallowing, too loudly or too clearly.
• Sensation of fullness or pressure in the ear.
• Muffled hearing that reduces clarity or volume of sounds.

Ear Plugging from Tepezza

Ear plugging sensation is a condition where a person experiences a feeling of fullness or blockage in the ears, similar to what one might experience when flying or diving. It can occur in one or both ears and can range from mild to severe, affecting a person’s ability to hear or communicate clearly.

The symptoms of ear plugging sensation caused by Tepezza often include:

• A feeling of fullness or pressure in the ears.
• Feeling that ears need to “pop”.
• Difficulty hearing or communicating clearly.
• Tinnitus or ringing in the ears.
• Dizziness or vertigo.
• Ear pain or discomfort.
• Itching or irritation in the ear canal.

Is Tepezza hearing loss permanent?

Tepezza hearing loss side effects can be permanent if individuals do not receive routine auditory monitoring to identify symptoms in the early stages before irreversible damage occurs.

Research has shown that early detection and close monitoring are key for preventing permanent hearing damage from Tepezza. By recognizing hearing loss quickly, doctors may be able to adjust or stop Tepezza treatments to reverse damage to the individual’s auditory system.

Is Tepezza hearing loss reversible?

Tepezza side effects may cause a condition known as ototoxicity which can lead to both temporary and permanent hearing loss, depending on the length of exposure and severity of the damage. Ototoxicity is when exposure to certain medications cause damage to the ear or auditory nerve, resulting in varying degrees of hearing loss.

When ototoxicity results in irreversible hearing loss, it means that the damage to the inner ear or auditory nerve is permanent and cannot be repaired.

Tepezza Hearing Loss Settlements May Be Available

Due to Horizon Therapeutics apparent failure to warn about the severity of Tepezza hearing loss injuries, settlements may be available for individuals diagnosed with hearing loss from Tepezza.

Drug manufacturers have a duty to evaluate risk factors and adequately research the efficacy and safety of a drug before offering it to individuals. The results of two clinical trials show that Horizon was aware of hearing loss side effects linked to Tepezza.

However, rather than disclosing the hearing risks and recommending patients undergo baseline audiogram testing, the manufacturer pushed Tepezza through the FDA’s fast-track drug approval program and began aggressively marketing Tepezza as a first-of-its-kind drug to treat symptoms of Thyroid Eye Disease (TED).

If you or a loved one developed hearing loss or other hearing complications after receiving Tepezza injections, you may be eligible for a settlement.

Even if you just have questions about the growing Tepezza lawsuit, we are here to help. You can give us a call at 1-800-522-0102 or schedule a free consultation below.

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