Ireland-based drugmaker, Horizon Pharmaceuticals, is facing a growing number of lawsuits for their Thyroid Eye Disease (TED) drug, Tepezza, alleging the drug caused permanent hearing loss and tinnitus. The lawsuits alleged that the drugmaker failed to adequately warn users of the risks associated with the popular Thyroid Eye Disease treatment. As a result, the FDA has announced a warning label update which now discloses side effects of Tepezza including that it “may cause severe and permanent hearing damage.”
Thyroid Eye Disease Drug Tepezza Introduced To U.S. Market
Tepezza was introduced to the market on January 20, 2020, as the first medication approved by the FDA to treat bulging eyes and double vision resulting from Thyroid Eye Disease. Thyroid Eye Disease is an autoimmune condition that causes inflamed eye muscles, eyelids, tear ducts, and fatty tissue surrounding the eye – often leading to swollen eyes and double vision.
The FDA granted Tepezza’s biologics license application (BLA) for priority review, in addition to a Fast Track and Breakthrough Therapy Designation. Additionally, Tepezza received an Orphan Drug designation and was supported, in part, by the FDA’s Orphan Products Grants Program, which provides grants for clinical studies on the safety and efficacy of products for use in rare diseases or conditions. The treatment, which is currently the only prescription drug used to treat TED in the United States, is administered to patients once every three weeks, for a total of eight infusions.
Shortly after Tepezza was approved in the U.S., sales of the prescription medication skyrocketed, exceeding over $3 billion in sales by the end of 2021. But concerns quickly emerged over the potential side effects and questions of whether the drugmaker sufficiently researched the treatment or disclosed to consumers the risks which arose and were apparent amongst the medical community.
Prior to The FDA’s new version of the Tepezza prescribing information guide (which was released in 2022), the drug’s label did not include warnings that Tepezza could cause harmful hearing loss and tinnitus when used as prescribed. The new section added by the FDA includes warnings and precautions about the risk of severe hearing loss which may be permanent. The new Tepezza hearing loss warnings also now direct that doctors should assess patients’ hearing before, during, and after using Tepezza.
Lawsuits Against Tepezza for Hearing Loss
Hundreds of former Tepezza users have filed product liability lawsuits against Horizon, alleging that they have been left with permanent hearing problems from Tepezza – a risk that was not adequately disclosed as a side effect on the initial warning labels. The former users maintain they could have avoided permanent damage to their ears if Horizon Pharmaceuticals, at the time of drug’s release, had provided accurate warnings about the importance of monitoring hearing before and during treatments.
The lawsuits allege the drugmaker should have known that Tepezza could cause hearing loss before the drug was ever introduced, since it works by blocking a protein called IGF-1R, which can harm hair cells responsible for hearing and balance. The lawsuits claim the drugmaker failed to conduct proper follow-up procedures or disclose the potential side effects related to IGF-1R proteins.
Tepezza was originally submitted to the FDA for approval using fewer than 100 patients enrolled in clinical trials, according to the lawsuit. In two of the clinical trials conducted prior to the FDA’s approving the drug, otologic symptoms were reported in 10 percent of patients. And a new study of 28 patients found a much higher rate. The lawsuit will therefore likely center on an alleged underreporting of the quantity and magnitude of otologic injury.
Contact Cellino Law If You’ve Suffered Hearing Loss After Tepezza Use
If you have received at least two infusions of Tepezza intravenously at a medical facility since February of 2020 and have experienced and of the below symptoms, you may qualify for compensation as part of the ongoing Tepezza lawsuit:
- Ongoing hearing loss or deafness
- Ongoing ringing in the ears (tinnitus)
- Muffled hearing
- Ongoing sensation of ears being plugged
- Eustachian tube dysfunction
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