The U.S. Food and Drug Administration (FDA) has added new information to the prescribing information guide for Tepezza, the thyroid eye disease (TED) drug subject to dozens of lawsuits alleging that the drug caused users to develop severe hearing loss, Endpoint News reported.
The FDA added a new section to the warnings and precautions section of Horizon Therapeutic’s monoclonal antibody drug (teprotumumab-trbw) on July 20, with updated information warning users about the risk of severe hearing loss, which has been permanent in some cases.
The new warning label also urges doctors to “assess patients’ hearing before, during, and after treatment with Tepezza and consider the benefit-risk of treatment with patients.”
Tepezza, an insulin-like growth factor-1 receptor inhibitor, is used for symptoms of TED, including eye bulging and double vision. The drug, introduced in early 2020, was the first approved by the FDA to treat these specific symptoms of this autoimmune disorder. Despite the rarity of the disease, affecting 19 out of 100,000 people, according to the American Association of Ophthalmology, Horizon Therapeutics generated sales of over $1 billion from the drug in 2020, company statistics show.
Plaintiffs in the Tepezza multidistrict litigation (MDL), approved for consolidation on June 5, claim that Horizon Therapeutics failed to adequately warn users about the risk of hearing loss. Moreover, people who have filed Tepezza personal injury claims allege that Horizon Therapeutics may have known or should have known about the risk of hearing loss because of the drug’s mechanism, which works by blocking the protein IGF-1R. As a consequence of this action, sound-wave-detecting hair cells in the inner ear can become damaged, potentially altering hearing and balance.
Complaints in the MDL, which currently number approximately 100 cases, also accuse Horizon Therapeutics of failing to conduct proper follow-up in the less than 100 test subjects enrolled in the clinical trial.
Approximately 90 cases have been assigned to the MDL in the Northern District of Illinois. Legal experts expect hundreds – if not thousands – of more cases to be added to the MDL in the future.
If you have suffered hearing loss as the result of taking Tepezza, you may be able to recover financial compensation. Contact MedTruth for a free case evaluation and begin your journey to justice today.