Tepezza is the first prescription drug approved by the FDA to treat thyroid eye disease (otherwise known as Grave’s eye disease), a condition in which the eye muscles, tear glands, eyelids, and fatty tissue behind the eye are inflamed. This is an autoimmune disease that causes swollen, red eyes, double vision, and eye bulging. Recently, it was found that the use of teprotumumab, the active ingredient in Tepezza, may lead to hearing loss and tinnitus. According to the Endocrine Society, up to 65% of those who use the medication regularly, specifically four times a day, come to struggle with some degree of hearing loss. The Tepezza infusion may cause potentially irreversible hearing loss, ranging from mild to severe, according to a study from Ophthalmic Plastic and Reconstructive Surgery.
Up to 85% of Tepezza users might experience hearing loss, according to a study from the Journal of the Endocrine Society, information that came to light just one year after the drug was approved by the FDA. While the label contains warnings for side effects such as infusion reactions, exacerbation of preexisting irritable bowel disease, and hyperglycemia, it fails to address hearing loss, tinnitus, increased sensitivity to sound or hearing muffled sounds. The study also found that the most common symptoms Tepezza use had caused were a sensation of ear plugging and muffled hearing.
Administered as an intravenous injection, this new drug that benefits from orphan drug status, is a promising new therapy for moderate to severe thyroid eye disease, but there is serious concern about irreversible adverse effects such as hearing loss and tinnitus.
In light of the above, the financial downside is that in addition to the Tepezza infusion treatment costs, one may have to take into calculation hearing loss related costs too, which can prove to be just as expensive as the treatment itself.
The manufacturer of Tepezza is Horizon Therapeutics USA Inc. It is located in Chicago, Illinois, but the main headquarters of the company are in Dublin, Ireland. The pharmaceutical manufacturer made $3.23 billion in drug sales in 2021. Horizon Therapeutics USA Inc. was founded in 2008 with the mission of delivering "medicines for rare, autoimmune and severe inflammatory diseases." The CEO of the company is Timothy P. Walbert, diagnosed himself with a rare autoimmune disease.
In the case of Tepezza, Horizon Pharmaceuticals failed to adequately warn about the risk of hearing loss and tinnitus. Prior to the launch of the drug on the market, a 10% chance of developing otological symptoms was mentioned, but after only one year, this percentage escalated to more than six times the initial figure, reaching as much as 65%.
If you developed hearing loss or tinnitus as a result of using the Tepezza infusion, you might be eligible to file a claim with the manufacturer, which can result in financial compensation. Our team will carefully review your medical records to determine whether you are a potential claimant.
To participate in a Tepezza lawsuit, you need to meet the following criteria:
Though hearing loss and tinnitus have the strongest association with Tepezza infusion use, the drug was found to cause other hearing-related side effects for which you might qualify to file a claim. Other studies discovered that additional adverse effects experienced by Tepezza infusion users include:
Researchers found that although a few patients experienced improvement three months after ceasing the use of the Tepezza infusion, many continue to struggle with the adverse effects of the drug. Consequently, if you have any of these issues, we strongly encourage you to contact Atraxia Law, as our team specializes in evaluating defective drug claims. We have over 20 years of experience, and given that you have a valid Tepezza infusion hearing loss or tinnitus claim, our team has the necessary knowledge and resources to point you to the best hearing loss lawyers in your area.
In August 2022, Daniel Weibel, a resident of Arizona, filed a lawsuit against Horizon Pharmaceuticals Inc. He claims his permanent hearing loss is the consequence of having taken Tepezza between June 2020 and September 2020. Neither the man nor his physician was aware of the risk of hearing loss or tinnitus, according to the complaint. The lawsuit alleges that "numerous patient reports, scientific studies, and even Defendant's post-marketing studies have established that Tepezza causes hearing loss. Nevertheless, Defendant failed to warn, instruct, advise, educate, or otherwise inform Tepezza users." Daniel Weibel filed the lawsuit in the U.S. District Court for the Northern District of Illinois.
Despite the allegations, Horizon Therapeutics USA Inc. insists the label did warn of hearing loss. In October, the drugmaker filed a motion to dismiss the plaintiff's complaint, alleging that Daniel Weibel "fails to state plausible claims for failure to warn and design defect under Arizona law, which applies to this case" and that "punitive damages are not allowed under Arizona law because Tepezza is FDA-approved." In December, the pharmaceutical company Amgen agreed to pay $28.5 billion to acquire Horizon Therapeutics USA Inc. This may also include potential liability for a growing number of Tepezza lawsuits filed by people who developed hearing loss.
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Talking to a lawyer can be intimidating and scary. We help you understand what is involved in a claim and if you potentially qualify before we pass you on to an Attorney. Atraxia Law is the first step to see if you qualify for compensation. We have successfully helped individuals who have been involved with challenging personal injuries that have resulted in a cash payout. Our team will carefully go over your specific situation so we have a clear understanding of your needs and will determine if you meet the preliminary requirements for a claim. This process is a quick and simple phone call with one of our case managers. We look forward to hearing from you.