Tepezza

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Tepezza Causes Hearing Loss

“Manufacturers of pharmaceutical drugs and infusions are required to disclose serious side effects of their products, so patients and their physicians can fully evaluate the benefits versus potential risks of using a new drug on the market. This especially true in a situation, like here, where TED patients who are at risk for potential permanent loss of vision are placed in potential risk of permanent hearing loss,” explains attorney Teresa Curtin.  

“Given that visually impaired patients rely on their sense of hearing to function independently in the world and communicate with others, any hearing loss needs to be vigilantly guarded against. The failure of Horizon Therapeutics to properly test and monitor hearing loss prior to Tepezza entering the market needs full investigation.”

She emphasizes, “We are grateful that Tepezza’s label has been updated to more fully report the dangers of hearing loss from use of this drug, but sadly this label update is too late for those patients dealing with serious hearing loss induced by Tepezza, on top of the vision loss caused by TED.” 

FDA Takes Action on Tepezza Label

On July 20, 2023, the U.S. Food and Drug Administration (FDA) reported an updated warning label guide of Tepezza injections that included severe and possibly irreversible hearing impairment. The FDA approved a revised version of the Tepezza prescribing information guide that warns of potential severe and even permanent hearing loss. The revamped guide suggests medical practitioners monitor patients’ hearing before, during, and following Tepezza infusions. ⁽¹⁾

What Is Tepezza?

Tepezza “is used to treat thyroid eye disease (TED)… a disorder in which the immune system causes inflammation and swelling behind the eye.” ⁽²⁾  

Tepezza “is an insulin-like growth factor-1 receptor inhibitor indicated for the treatment of Thyroid Eye Disease.” ⁽³⁾  The treatment is administered once every three weeks, for a total of eight infusions. 

Unfortunately, new scientific research suggests that Tepezza has caused some patients to suffer permanent hearing damage or ringing in the ears (tinnitus). 

What Is TED?

TED is a vision-threatening and progressive autoimmune disease often associated with hyperthyroidism. Hyperthyroidism occurs when your thyroid gland overproduces hormones.

TED symptoms can prevent your eyelids from closing and cause bulging eyes, double vision, pain, and loss of vision due to damage to the optical nerve. Tepezza infusions are intended to help lessen these symptoms. 

Tepezza Side Effects

Tepezza may cause the following hearing related side effects:

• Permanent loss of hearing (sensorineural hearing loss).
• Ringing in the ear (tinnitus).
• Hyperacusis, a hearing disorder involving sensitivity to sounds.
• Inability to hear clearly or partial loss of hearing (hypoacusis).
• Hearing your own voice as too loud or echoing (autophony). 
• Eustachian tube dysfunction.

Other common adverse reactions to Tepezza include: ⁽⁴⁾

• Diarrhea.
• Nausea
• Muscle spasms.
• Alopecia.
• Fatigue.
• Increased blood sugar level.
• Dry skin.
• Dysgeusia.
• Headache.
• Weight lost.
• Nail disorder, such as nail discoloration.

Tepezza may also cause reactions to the infusion itself. Signs and symptoms include temporary increases in blood pressure, as well as feeling hot, having a fast heart rate, labored breathing, and muscular pain. Other possible complications of Tepezza include worsening of preexisting inflammatory bowel disease (IBD) and an unwanted immune response. ⁽⁵⁾ 

Studies Show Tepezza Can Cause Permanent Hearing Loss

In two clinical trials conducted prior to the January 2020 FDA approval, the manufacturer reported hearing related side effects in 10% of patients taking Tepezza and that these symptoms “were reversible upon stopping the drug.” ⁽⁶⁾  In 2021, a study found the rate of hearing symptoms could be as high as 65% with some patients not regaining their hearing at one and six months after treatment. ⁽⁷⁾ 

Researchers of one case series stress the importance of objective testing of patients both before and after taking teprotumumab. They indicate “subjective hearing changes may not accurately reflect objective hearing function.” Their report suggests Tepezza may play a significant role in increasing a patient’s risk of developing “sensorineural hearing loss.” ⁽⁸⁾ 

Studies show use of teprotumumab can lead to chronic sensorineural hearing loss. In some cases, patients reported experiencing the onset of symptoms of hearing impairment after just three infusions. Even several months after discontinuing treatment, some patients experienced no improvement in their hearing. ⁽⁹⁾

Researchers advise, “It is imperative to counsel patients on the risk of potentially irreversible sensorineural hearing loss prior to the initiation of teprotumumab.” Because of the potential for serious complications, researchers suggest you work with a team of doctors, including ophthalmologists, otolaryngologists, audiologists, and endocrinologists. Researchers also recommend examining patient hearing before treatment, as well as following treatment, with Tepezza. ⁽¹⁰⁾

Need to Monitor for Hearing Loss Symptoms

Medical professionals should be “vigilant monitoring for the development of hearing loss.” Infusions may have a cumulative effect. “Otolaryngologists and endocrinologists should collaborate so that patients receive pretreatment hearing tests, monitoring, and education … on otologic symptoms.” ⁽¹¹⁾ 

Other research results “demonstrate a much higher percentage of teprotumumab-treated TED patients with new otologic symptoms than previously reported (81.5% vs 10%). Symptoms ranged from mild (the sensation of ear popping once per week) to significant declines in word recognition resulting in a change from serviceable to nonserviceable hearing.” ⁽¹²⁾

Researchers recommend providers consider a patient’s “history of hearing loss symptoms prior to initiating therapy. We recommend offering baseline audiometric and PET testing to all patients … with repeat testing should symptoms develop, and posttreatment testing if symptoms persist. Speech testing and speech in noise testing may be of particular importance … because of possible synaptopathy induced by teprotumumab.” ⁽¹³⁾

Doctors should consider discontinuing treatment if patients meet “ASHA ototoxicity criteria.” Doctors should also look out “for any hearing loss that is worrisome.” ⁽¹⁴⁾

Irreversible Hearing Damage Possible

In one study, most “TED patients treated with teprotumumab experienced otologic symptoms. Importantly, less than half of patients with subjective hearing loss experienced symptom resolution at mean follow-up of 39.2 weeks.” Doctors should “identify risk factors, and create guidelines for screening, monitoring, and management of auditory side effects in teprotumumab-treated patients.” ⁽¹⁵⁾ 

In fact, “Teprotumumab may cause a spectrum of potentially irreversible hearing loss ranging from mild to severe.” Researchers recommend medical professionals “adopt a surveillance protocol to include an audiogram and tympanometry before, during and after infusion, and when prompted by new symptoms of hearing dysfunction.” ⁽¹⁶⁾

Teprotumumab “may cause a range of hearing changes.” Researchers recommend “a screening protocol to include an audiogram and tympanometry testing before, during, and after the infusion cycle, as well as routine symptom elicitation during the course of the infusion, to identify early hearing changes and prompt important therapeutic discussions with patients.” ⁽¹⁷⁾

Why Are People Filing Tepezza Lawsuits?

Lawsuits filed against Horizon Therapeutics as the manufacturer of Tepezza allege that the label on the drug did not sufficiently warn patients or doctors about the potential risk for hearing loss, nor did the Horizon Therapeutics warn how hearing issues could be permanent for those taking the eye drug. The use of Tepezza is linked to hearing loss and tinnitus, a ringing in the ears. Multiple lawsuits claim that patients were not warned Tepezza could cause significant, permanent, hearing damage, including deafness and tinnitus. ⁽¹⁸⁾

Weitz & Luxenberg is pursuing lawsuits against the manufacturer. Our lawsuits, on your behalf, can become part of the multidistrict litigation (MDL). These lawsuits claim Horizon Therapeutics, Inc. failed to adequately test the product to ensure its safety and warn patients about the risks of ear injury and permanent hearing damage.

In addition, lawsuits claim the company misled both patients and doctors about the potential risk of hearing loss and other adverse hearing related events. Horizon Therapeutics said possible damage could be reversed. 

Lawsuits say the manufacturer downplayed the risk that taking Tepezza could result in irreversible hearing loss. And now people — like you — are living with permanent hearing damage.

Who Can File a Tepezza Lawsuit? 

Were you or a loved one prescribed Tepezza for treatment of your thyroid eye disease (TED)? Have you received at least two infusions by a medical facility intravenously? 

You can file a Tepezza lawsuit if you received a teprotumumab or Tepezza infusion and suffered irreversible hearing loss or tinnitus as a result.

Have you or a loved one experienced any of these complications after being treated with Tepezza?:

• Ongoing hearing loss or deafness.
• Hypoacusis, partial or total loss of hearing acuity.
• Ongoing ringing in the ears (tinnitus).
• Autophony, loud hearing of your own voice. 
• Muffled hearing.
• Ear plugging sensation.
• Eustachian tube dysfunction.

If so, Weitz & Luxenberg attorneys can let you know what legal options are available. 

Legal Options 

Already, multiple lawsuits have been filed against Horizon Therapeutics. Many of these lawsuits are on behalf of people who are in a similar situation to yours. You took a medicine to help with your vision problems. Now, that medicine has caused you to have hearing problems, as well.

Sadly, many people have experienced irreversible hearing loss or tinnitus that has not gone away. The damage seems to be permanent. The tragedy is that prompt medical treatment or discontinuance of Tepezza might have counteracted the hearing damage if proper medical monitoring had been included.

Now you are facing a loss in two of your senses — sight and hearing — instead of just one. We invite anyone who has experienced tinnitus or significant hearing loss after taking Tepezza to contact us. You may be able to join our litigation.

W&L attorneys are known for our efforts in representing thousands of clients across the country and securing just and appropriate compensation on their behalf. We help people who have sustained serious injuries due to the negligence of others.

How W&L Can Help

The lawyers at Weitz & Luxenberg are prepared to help you. We are recognized nationally as a highly regarded law firm, having success in defective drug and device cases. 

Our knowledgeable lawyers help evaluate your case. Then we can take the legal actions necessary to secure the best possible outcome for you. We have a solid, long-running track record for winning cases.

Here are just a couple examples:

• Weitz & Luxenberg achieved a $13.5 million verdict for our client who suffered a debilitating heart attack after taking the drug Vioxx, intended to alleviate arthritis and other types of pain. 
• W&L attorneys received a $9 billion verdict on behalf of a client who developed bladder cancer after taking the diabetes drug Actos.