What does research say about Tepezza and hearing loss?
FDA’s label for Tepezza warns that it may cause severe hearing problems, including hearing loss. In some cases the loss may be permanent. A label warning does not prove that the drug caused any one person’s hearing loss.
In the two studies before approval, 8 of 84 people who got Tepezza (10%) had hearing problems. None of the 86 people who got a dummy drug, called a placebo, did. FDA counts tinnitus and some other ear problems under hearing impairment.
The current label also reports two later studies done after approval. In them, 19% of people treated with Tepezza had hearing problems during the part of the study when no one knew who got which drug.
The first label, in 2020, listed hearing problems as a side effect. FDA added a separate hearing warning in July 2023. It tells doctors to check hearing before, during and after treatment.
The lawsuits claim Tepezza caused lasting hearing loss and tinnitus. The panel that grouped the federal cases said whether the drug can cause these injuries is a shared question. In the federal court records we read, we found no ruling that Tepezza causes hearing loss.