Tepezza and Hearing Loss

In January 2020, the U.S. Food and Drug Administration approved Tepezza, manufactured by Horizon Pharmaceuticals, to treat thyroid eye disease. TED inflames the eye muscles, eyelids, tear glands and fatty tissues behind the eye, which pushes the eyes forward causing bulging (known as proptosis) and may cause double vision. The signs and symptoms of TED can vary greatly from one person to another. Eye symptoms can range from mild to severe. Initial symptoms include redness, irritation, and discomfort of the eyes and eyelids. Additional symptoms and signs can include blurred vision, double vision (diplopia), misalignment of the eyes (strabismus), chronic bloody eyes, inflamed white area of eye, constant watery eyes due to the excess formation of tears, swelling near the upper and lower eyelids, intolerance of bright lights, and difficulty moving the eyeballs.

Almost immediately after the FDA approved Tepezza, patients and doctors began reporting serious complications related to hearing problems ranging from mild and temporary to permanent hearing loss in patients taking Tepezza. At the same time, the results of multiple patient-focused studies demonstrated clear evidence that Tepezza poses a risk of mild to significant and permanent hearing loss and impairment. Predictably, the FDA required a post-marketing study which began in the fourth quarter of 2021, and, on February 22, 2022, Horizon issued a press release announcing results from the post-marketing safety analysis that noted multiple findings of hypoacusis (reduction in hearing) followed by tinnitus (ringing in the ears).       

Armed with this evidence, Horizon should have at least changed the Tepezza label to include warnings and instructions addressing the risk of injury associated with the drug. Horizon further needed to warn patients and the medical community that patients receiving Tepezza should undergo regular audiological testing to detect hearing loss. Unfortunately, Horizon didn’t issue these warnings or give adequate guidance.

Our team of skilled attorneys led by Mark Abramowitz, who was appointed to the plaintiffs’ executive committee by the federal court overseeing this litigation, represents hundreds of victims of Tepezza and is seeking hundreds of millions of dollars to compensate them for the debilitating hearing loss they suffered as a result of Horizon’s misconduct.