New Hearing Loss Warnings Added to Tepezza Drug Label

As Tepezza maker Horizon Therapeutics faces dozens of lawsuits alleging that the thyroid eye disease (TED) drug causes permanent hearing loss in users, the U.S. Food and Drug Administration (FDA) has finally approved a hearing impairment warning for the Tepezza label. The new warning alerts patients to the fact that Tepezza “may cause severe hearing impairment including hearing loss, which in some cases may be permanent,” and urges providers to “assess patients’ hearing before, during, and after treatment with TEPEZZA and consider the benefit-risk of treatment with patients.” If you or someone you love suffered hearing loss, tinnitus, autophony, or any other type of hearing damage during or after Tepezza treatment, contact Consumer Safety Watch immediately. You may be entitled to financial compensation for your injuries, which an experienced Tepezza hearing loss attorney can help you pursue. 

What is Tepezza?

Tepezza (teprotumumab-trbw) is an intravenous human insulin-like growth factor-1 receptor (IGF-1R) inhibitor approved to treat adults with thyroid eye disease, a progressive autoimmune disease characterized by inflammation and damage to tissues around the eyes, leading to bulging eyes and double vision. As the first medication approved to treat thyroid eye disease, Tepezza has been prescribed to thousands of patients with TED or Graves’ disease. However, concerns have emerged recently about the potential for Tepezza to cause irreversible hearing damage in users, and Horizon Therapeutics faces a growing number of claims that it failed to properly research the treatment or disclose possible side effects to users. Tepezza has only been on the market in the United States since January 2020, and already, it has been named in dozens of lawsuits alleging debilitating side effects like hearing loss, tinnitus, muffled hearing, hypoacusis, autophony, and deafness. 

Tepezza’s New Hearing Impairment Warning

Just last week, amid a growing number of reports of hearing loss side effects occurring among Tepezza users, the FDA released an updated version of Tepezza’s prescribing information guide, complete with a new hearing impairment statement under the “Warnings and Precautions” section. The new warning states that: “TEPEZZA may cause severe hearing impairment including hearing loss, which in some cases may be permanent. Assess patients’ hearing before, during, and after treatment with TEPEZZA and consider the benefit-risk of treatment with patients.” The hearing impairment warning closely resembles that which plaintiffs in the Tepezza litigation say Horizon should have provided when the medication was first introduced more than three years ago. 

Tepezza Hearing Problems May be More Common than Reported

Tepezza has been linked to hearing problems since its clinical trial phase prior to FDA approval. However, the manufacturer has consistently claimed that hearing-related adverse events affect less than 10% of Tepezza patients – the most common events being hypoacusis (reduction in hearing), followed by tinnitus (ringing in the ears) – the majority of which are “mild to moderate and reversible.” Even with recent research suggesting that Tepezza-related hearing problems may be more common than initially reported, Horizon has resisted adding a hearing loss warning to the Tepezza label. This new addition to the drug label comes after a recent study published in the journal Endocrine Practice found that adverse hearing-related events occurred in more than 16% of study participants taking the thyroid eye disease drug. According to researchers, the most commonly reported hearing-related events were tinnitus, hearing loss/impairment, hyper/hypoacusis, autophony, and eustachian tube dysfunction.

Contact Consumer Safety Watch Today for Help

Tepezza lawsuits allege that Horizon Therapeutics knew or should have known about the potential for the TED medication to cause irreversible hearing loss and failed to warn patients or the medical community. Plaintiffs claim that they could have avoided suffering permanent hearing damage if Horizon had provided prompt warnings about the importance of monitoring patients’ hearing before, during, and after treatment with Tepezza. If you or a loved one took Tepezza for thyroid eye disease or Graves’ disease and subsequently suffered hearing damage, don’t wait to speak to a Tepezza injury attorney. You may have grounds to file a Tepezza lawsuit against Horizon Therapeutics, which may help you recover damages for your medical bills, lost wages, pain and suffering, diminished quality of life, and loss of enjoyment of life. Contact Consumer Safety Watch as soon as possible to find out how to go about pursuing a legal claim against Horizon Therapeutics.