Study Says Tepezza Users May Need Second Injection to Effectively Treat Thyroid Eye Disease

Study Says Tepezza Users May Need Second Injection to Effectively Treat Thyroid Eye Disease

The thyroid eye disease (TED) treatment, Tepezza, has come under scrutiny for its newly discovered risk of hearing loss. New research shows that some people with thyroid eye disease may require a second round of injections in order to benefit from Tepezza. This constitutes a concern because that may elevate the existing risk of permanent hearing loss or tinnitus. 

The makers of this new drug are facing scrutiny because patients claim that they intentionally trivialized the potential severity of the hearing loss and failed to warn consumers of its true risks. If you have undergone Tepezza treatments to alleviate your thyroid eye disease and have subsequently experienced prolonged hearing loss, you should consider contacting a Tepezza hearing loss lawyer to review your options for recovering damages like medical bills, lost wages, and loss of quality of life.

Tepezza Linked to Permanent Hearing Loss and Tinnitus

Tepezza is a drug given by injection over a period of time to treat Graves’ Orbitopathy, another name for thyroid eye disease. Thyroid eye disease refers to the inflammation and swelling that is caused by an atypical immune system response. It can cause the eyes to swell and bulge uncomfortably to the point of blurry and double vision. Thyroid eye disease is also known to be progressive, with previous treatment options including surgery and steroids that include unpleasant side effects.

In 2020, a new drug known as Tepezza became available as an alternative treatment. One of the known side effects of Tepezza is temporary hearing loss or tinnitus, which is a persistent ringing in the ears. Tepezza hinders the growth of insulin-like growth factor 1 receptors (IGF-IRs). IGF-1Rs are critical to protecting the inner ear hair cells from being damaged by noise. As previously stated, this was a risk that horizon therapeutics had acknowledged.  

What had not been advertised to consumers is that the hearing loss or tinnitus may be permanent. Previously, the effects were thought to be reversible coinciding with the ceasing of Tepezza injections. This was discovered in a study that examined the rates of hearing loss among patients who had received injections of teprotumumab, another name for Tepezza. Currently, Tepezza is the only FDA-approved drug available for this condition.

FDA Fast-Tracked Tepezza to Offer Relief for Thyroid Eye Disease

In 2020, the approval process for Tepezza was streamlined thanks to a provision known as the Orphan Drug policy. Essentially, the FDA wanted to incentivize drug makers to continue developing products for rare diseases, like conditions associated with Graves’ disease. The Orphan drug policy offers applicants the “potential [for] seven years of market exclusivity after approval”.

The underlying implication for this situation is that the makers of Tepezza may have intentionally undersold the risks of permanent hearing loss to the FDA in order to obtain their approval. As the makers of the only FDA-approved drug to treat thyroid eye disease, they would have a profitable monopoly over this niche market. A failure to provide the FDA with accurate data or place appropriate warning labels on their products could leave them open to product liability lawsuits from injured Tepezza users.

Second Course of Tepezza Treatments Could Increase Risk of Permanent Hearing Loss

After Tepezza was approved by the FDA, horizon therapeutics continued to conduct studies on its efficacy and risks. Some patients were motivated to obtain a second round of treatment if they feel like the first was ineffective. In fact, according to Tepezza’s own makers, about 5% of patients who use Tepezza to treat their thyroid eye disease undergo a second course of treatment. The significance of this is that additional Teppeza treatments would only further increase the risk of hearing loss.

Damages in a Tepezza Hearing Loss Lawsuit

In the event that the hearing loss is permanent, an individual may be forced to dramatically adapt their lifestyle and career. The loss of hearing may be especially frustrating and traumatic for people who are already struggling with their vision. Hearing loss can interfere with communication, which may make it difficult to continue your prior job, navigate relationships, and function independently. This may result in a number of financial and emotional losses. 

Plaintiffs who have been injured by another party’s negligence have the right to seek compensation for their economic and non-economic damages in a personal injury lawsuit. Economic damages have a quantifiable, established value, like the cost of a monthly prescription. Non-economic damages are subjectively calculated and are intended to compensate for emotional losses, like not being able to hear your child’s concert performance. 

Examples of Damages in a Tepezza Hearing Loss Lawsuit:

  • Medical bills
    • Medication
    • Hearing aids
    • Medical images
  • Job-related losses
    • Lost wages
    • Reduced earning capacity
    • Missed promotions
    • Job retraining
  • Pain and suffering
  • Loss of quality of life

Makers of Tepezza Face Product Liability Lawsuits

The product liability lawsuits against Horizon Therapeutics, the makers of Tepezza, rest on two primary accusations. The first is that they were aware of the risk of permanent hearing loss, or at least had the responsibility to be aware through their own testing processes. Second, they did not warn consumers that their hearing loss or tinnitus could be permanent

In order to recover the value of your damages, you and your product liability attorney will need to be able to demonstrate that Horizon Therapeutics violated their duty of care to you, which resulted in your hearing loss and subsequent damages. The most effective way to ensure that you receive the maximum amount of compensation you are eligible for is by hiring a personal injury lawyer with experience handling product liability lawsuits. 

A personal injury lawyer can be instrumental in presenting evidence of liability, calculating the value of damages, and negotiating a fair settlement. If you have suffered from hearing loss or tinnitus after getting injections of Tepezza to treat your thyroid eye disease, you should reach out to a product liability attorney as soon as possible to discuss your legal options.


Matthew Dolman

Personal Injury Lawyer

This article was written and reviewed by Matthew Dolman. Matt has been a practicing civil trial, personal injury, products liability, and mass tort lawyer since 2004. He has represented over 11,000 injury victims and has served as lead counsel in over 1000 lawsuits. Matt is a lifetime member of the Million Dollar Advocates Forum and Multi-Million Dollar Advocates Forum for resolving individual cases in excess of $1 million and $2 million, respectively. He has also been selected by his colleagues as a Florida Superlawyer and as a member of Florida’s Legal Elite on multiple occasions. Further, Matt has been quoted in the media numerous times and is a sought-after speaker on a variety of legal issues and topics.

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