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Tepezza is a medication designed to treat a rare condition called thyroid eye disease. Horizon Therapeutics, the company that makes Tepezza, was founded for the purpose of developing treatments for rare conditions. One of the side effects of taking Tepezza was that it could cause hearing loss. This was only supposed to be temporary and should return to normal after the treatment was complete.
However, many have found that the hearing loss and tinnitus they experienced as a result of taking Tepezza were permanent. Lawsuits have already been filed against Horizon for failing to adequately warn patients of the risk of permanent hearing loss and tinnitus and for failing to adequately warn doctors that they needed to monitor patient hearing during the Tepezza infusion process.
If you have been diagnosed with temporary or permanent hearing loss or tinnitus as a result of taking Tepezza to treat thyroid eye disease, you may have a case. Contact Farah & Farah today for a free consultation.
Tepezza is the brand name of teprotumumab, a medication that treats thyroid eye disease. It’s an infusion that is injected directly into the patient’s vein. The infusions are done at a pace of one every three weeks for a total of eight infusions over a period of twenty-four weeks total, which is about a period of six months. Each infusion period would last between 60 and 90 minutes.
The FDA approved Tepezza to treat thyroid eye disease on January 21, 2020.
It was found that patients treated with Tepezza experienced a reduction in their symptoms at a rate of 83%, compared to only 10% to 20 % of those who received a placebo.
Tepezza is manufactured by the Ireland-based company Horizon Therapeutics, which was founded in 2008 by CEO Tim Walbert. Walbert was diagnosed with an autoimmune disorder while he was in college. After seeing upwards of 100 different physicians regarding his condition, he was eventually diagnosed with a rare disease. He founded Horizon in order to help treat others who have rare conditions. The company began small but has now grown to the point where it has more than 2,000 employees across the globe.
Each dose of Tepezza includes the following:
Thyroid eye disease, or TED, is an eye condition that can result in damage to the tissues in the eyes. TED is an autoimmune disease, which means that it’s caused by the immune system, which is used to protect the body against diseases, infections, and other harmful conditions, attacks itself instead. Thyroid eye disease is similar to Graves disease and can be related. In some cases, TED and Graves disease are considered interchangeable names for the same condition.
Graves disease is an autoimmune disease that can impact the skin, eyes, and thyroid. The thyroid is a small gland that produces hormones used in the body’s metabolism, which controls how the body processes food and turns it into energy for you to use. Graves disease can result in hyperthyroidism, in which the thyroid produces too much of the thyroid hormone, as well as hypothyroidism, in which it doesn’t produce enough. By contrast, thyroid eye disease can occur even in people whose thyroid hormone levels are completely normal. The two diseases are similar and may be related in some cases.
The symptoms of TED can include:
You may be more at risk for developing TED if you are female, you have family members with thyroid eye disease, or your blood has low levels of the mineral selenium. On average, most people who develop TED are 43 years old, but it’s possible to develop it either younger or older than that.
Tepezza treats thyroid eye disease by blocking the cause of the swelling in the eyes. This helps to reduce the swelling, bulging, and redness in the eyes caused by TED.
Tepezza could have negative effects on those who are pregnant or who have one of the following conditions:
The most common side effects of Tepezza include:
If you experience any of the following severe side effects, you should see a doctor:
Researchers have found that the usage of Tepezza to treat thyroid eye disease is linked to hearing loss. They conducted a study and found that 85% of those whose TED was treated with Tepezza experienced side effects as a result. It was reported that 10% of people would experience hearing loss, which was supposed to return once they stopped taking Tepezza. In the study, the researchers analyzed twenty-eight patients, thirteen of whom were complaining of hearing loss symptoms. That number made up 46% of the patients participating in the study.
While the hearing loss was supposed to be reversible following the cessation of treatment, that wasn’t necessarily the case. One patient experienced an improvement but their hearing wasn’t back to normal. Others experienced no improvement in their hearing at all. The researchers concluded that anyone taking Tepezza should have their hearing tested and that the links between Tepezza and hearing loss should be studied further.
Other studies have linked Tepezza to tinnitus, which is characterized by a ringing in the ears. In this study, tinnitus occurred following three months’ worth of Tepezza treatments and was later followed by bilateral hearing loss.
Tepezza has been linked to the following types of hearing conditions:
Sensorineural hearing loss is a type of hearing loss caused by damage to the inner ear or issues with the neural pathways between the inner ear and the brain.
SNHL can be caused by the following:
Tinnitus is a ringing in the ears that isn’t coming from an external source. This means that you’re the only one who can hear it. 15 to 20% of people, especially older adults, experience tinnitus. It’s usually caused by a specific condition, including hearing loss for any reason.
Tinnitus can be caused by the following conditions:
The symptoms of tinnitus typically involve phantom noises that only you can hear, such as any of the following:
Hearing loss is described as being either unilateral or bilateral, no matter what causes the hearing issue. Unilateral means that the hearing loss is occurring in only one ear while bilateral indicates that the hearing loss is occurring in both ears.
Autophony is a condition in which your own voice sounds different to you. Typically, it’ll sound lower-pitched or louder than it normally does.
Horizon was aware of the risk of hearing loss and did acknowledge that risk. The company’s report stated that 10% of people taking Tepezza might experience hearing loss. They also said the risk was worth the treatment for thyroid eye disease. The company claimed that any adverse side effects experienced by those participating in their clinical trials were manageable.
However, many feel that this warning wasn’t sufficient because the hearing loss sustained from taking Tepezza wasn’t manageable as Horizon had said. Many also said that they weren’t aware of the risks of hearing loss prior to agreeing to take Tepezza to treat thyroid eye disease. Doctors weren’t aware of the risks or the need to monitor patients for hearing loss during and following treatment like the researchers who linked Tepezza to hearing loss in the first place. Plus, Horizon didn’t warn about permanent hearing loss as a possibility.
Beginning in the summer of 2022, patients who had suffered from permanent hearing loss or tinnitus as a result of having been treated with Tepezza started to file lawsuits against the company that manufactured the medication, Horizon Therapeutics. The plaintiffs claim that Horizon didn’t adequately warn either patients or doctors of the risk of permanent tinnitus or hearing loss as a result of taking Tepezza infusions.
Two lawsuits have been filed thus far in 2022, one in August and another in September. Both were filed in the Northern Illinois district. This is where Horizon has its United States-based headquarters. Because these lawsuits were only filed earlier this year, there has not yet been a settlement. More lawsuits are expected to follow, however.
If you have been diagnosed with temporary or permanent hearing loss or tinnitus as a result of undergoing Tepezza treatments for thyroid eye disease, then you may have a case against Horizon. Plaintiffs with eligible claims may seek compensation for lost work, medical costs, pain and suffering, and more. For a free consultation, contact Farah & Farah today. You won’t have to pay a dime unless your case is successful.