In one of the first hearing damage lawsuits brought against the makers of the controversial Thyroid Eye Disease (TED) drug Tepezza, an Arizona man diagnosed with permanent hearing loss alleges that Horizon Therapeutics failed to warn patients and doctors about the potential for Tepezza to damage hearing and cause tinnitus. According to the complaint, “Numerous patient reports, scientific studies, and even Defendant’s post-marketing studies have established that Tepezza causes hearing loss.” Yet, the Tepezza drug label downplays the severity of the hearing problems allegedly associated with Tepezza. If you or a loved one took Tepezza to treat Thyroid Eye Disease and subsequently suffered irreversible hearing loss, tinnitus, or another debilitating hearing problem, contact Consumer Safety Watch today to explore your possible compensation options.
Tepezza is an infusion administered intravenously for the treatment of Thyroid Eye Disease, a progressive autoimmune disease characterized by inflammation and damage to the tissues surrounding the eyes. Patients diagnosed with TED may suffer from symptoms like dry, red, or watery eyes, bulging eyes (proptosis), double vision, pain behind the eyes, and difficulty closing the eyes, among other symptoms. Tepezza is manufactured by Horizon Therapeutics and was approved by the FDA in January 2020 as the first drug treatment for TED.
In a news release issued on January 21, 2020, the deputy director of the Division of Transplant and Ophthalmology Products in the FDA’s Center for Drug Evaluation and Research claimed that Tepezza’s approval represented ”important progress in the approval of effective treatments for rare diseases, such as thyroid eye disease,” stating that “[Tepezza] has the potential to alter the course of the disease, potentially sparing patients from needing multiple invasive surgeries by providing an alternative, non surgical treatment option.” However, we now know that patients taking Tepezza as a treatment for TED may be at risk for a lifetime of hearing issues, including permanent hearing loss and/or tinnitus.
As a result of Horizon’s alleged failure to disclose the hearing loss side effects of Tepezza, the drug maker now faces claims by former Tepezza users who blame the company for their hearing-related injuries and damages. One of the first known Tepezza lawsuits was filed by Daniel Weibel, an Arizona man who received Tepezza infusions from June 2020 through September 2020 as a treatment for TED and/or Graves’ Disease, a disorder of the immune system that causes the overproduction of thyroid hormones (hyperthyroidism). During the course of his treatment with Tepezza, Weibel states that neither he nor his physician was provided with any warnings about the serious risk of debilitating and potentially permanent hearing loss and/or tinnitus associated with Tepezza treatment.
Weibel alleges in his complaint that Horizon Therapeutics “knew or should have known that Tepezza, when used as prescribed and intended, causes harmful hearing loss and other symptoms including tinnitus.” After all, there have been numerous consumer complaints and scientific studies, which provide “clear evidence of the dangers of Tepezza” with regards to hearing loss side effects. “Nevertheless,” Weibel’s complaint states, “Defendant failed to warn, instruct, advise, educate, or otherwise inform Tepezza users, Tepeza prescribers, or United States governmental regulators about the risk of hearing loss, or the need for medical, audiological monitoring.” In fact, the only mention of hearing loss on the Tepezza label is in the Clinical Trial Experience section, and there the drug maker characterizes hearing loss as an adverse event occurring in 10% of Tepezza users. However, more recent research has found that the actual rate of Tepezza-related hearing problems may be closer to 65%. Weibel also alleges in his complaint that Horizon represented to the FDA that reports of hearing loss occurring among Tepezza users in the clinical trials was “temporary and generally of limited duration,” when hearing loss side effects of Tepezza may actually be severe and permanent.
Tepezza treatment may have caused thousands of individuals already at risk for vision problems from TED to develop severe and potentially permanent hearing loss. If you or someone you know has suffered from hearing impairment, deafness, hearing loss, tinnitus, or any other type of hearing damage allegedly caused by Tepezza, do not hesitate to discuss your legal options with a Tepezza injury attorney. You may have grounds to file a Tepezza lawsuit against Horizon, in order to pursue fair and timely compensation for your medical expenses, lost wages, pain and suffering, permanent disability, and other damages. Contact Consumer Safety Watch right away to find out how we can help.