Tepezza was supposed to be a groundbreaking drug treatment for a vexing eye disorder. One recipient of the drug intended to treat problems with one of his senses alleges it instead caused permanent damage to another.
In a lawsuit filed on August 25, David Weibel alleges his use of Tepezza (also known as teprotumumab) for thyroid eye disease was the cause of permanent hearing loss. Weibel’s lawsuit alleges Horizon Pharmaceuticals Inc. failed to warn him or his doctors that the medication could cause hearing loss and/or tinnitus, according to the Complaint in Weibel’s lawsuit.
Weibel received infusions of Tepezza from June 2020 through September 2020, beginning his course of the drug less than six months after its approval by the U.S. Food and Drug Administration (FDA).
Thyroid eye disease, a condition that includes Graves’ eye disease, is a chronic inflammation of the muscle or tissue in and around the eye. The disease causes swelling of the eye or eyelid which creates a bulging appearance, and in some cases produces double vision.
According to Tepezza’s own label, as cited in Weibel’s Complaint, the “mechanism of action in patients with thyroid eye disease has not been fully characterized.”
Horizon Pharmaceuticals “willfully, wantonly and intentionally conspired, and acted in concert, to ignore relevant safety concerns and to deliberately not study the safety and efficacy of Tepezza,” according to the Complaint. As a result of the corporation’s negligence, Weibel suffered physical pain, mental anguish, medical expenses, and a diminished quality of life.
Tepezza Hearing Loss Side Effects Studies
According to the Complaint, clinical testing submitted to the FDA for teprotumumab consisted of just two trials, with only 84 patients taking the brand-new compound. Reports of hearing loss in the trials were represented as “temporary and generally of limited duration.”
A subsequent report, documenting adverse effects after Tepezza hit the market and capturing the experience of thousands of patients, found 10 percent of recipients reported either hearing loss, tinnitus, or both. Meanwhile, numerous publications conducted by doctors dating back to August 2021 have discussed the association of those side effects with the use of Tepezza.
A 2022 study of the use of Tepezza in 27 patients found that a clear majority (81.5 percent) reported some form of hearing dysfunction during the course of their taking Tepezza. Some of those suffering from auditory side effects would later report their symptoms had resolved. However, five of the 27 patients reported long-term hearing loss, including two who had subsequently begun to use hearing aids. “Hearing loss is a concerning adverse event” following the use of Tepezza, according to the study authors.
In a review of the study, Dr. Richard C. Allen wrote that its results supported previous findings of “potentially irreversible” hearing issues in patients who take Tepezza. “This risk should be explicitly discussed with patients prior to treatment with [Tepezza],” Allen wrote, “especially in those patients with baseline hearing loss.”
Other reports of Tepezza and hearing loss:
- A 61-year-old woman who reported hearing loss during her course of treatment with Tepezza was then treated with steroids, and elected to forgo future doses of Tepezza; four months later, her hearing had still not returned to normal.
- A 74-year-old woman experienced “rapidly progressive worsening” of hearing loss during her Tepezza treatment, while a 42-year-old man began to experience tinnitus.
- A woman taking teprotumumab stopped taking the drug after exhibiting “significantly worse” hearing than prior to treatment; six weeks later her side effect symptoms remained.
- A 57-year-old woman suffered first from tinnitus, then from hearing loss during her Tepezza treatment, which she subsequently paused; doctors reported they could “attribute the new hearing loss to teprotumumab treatment.”
- A 77-year-old woman experienced “severe” hearing loss following her fourth dose of Tepezza which continued to occur seven months after her final treatment; she had begun use of a hearing aid and was considering cochlear implants to counteract the hearing loss side effect.
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If you or a loved one have been diagnosed with any form of hearing loss after taking Tepezza, our lawyers would like to speak with you. You may be entitled to financial compensation.
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