Tepezza received a label update approved by the FDA, but did it shake its tinnitus causing past?

Patients who were given Tepezza via IV infusion and suffered hearing damage (or tinnitus) are still filing product liability lawsuits against the manufacturer despite the recent FDA update. Most of the plaintiffs were given this medication to help with their severe to moderate thyroid eye disease (TED).

Share Post:

Tepezza hearing loss

Table of Contents

Tepezza Hearing Loss Lawsuit Background

Tepezza (teprotumumab) is a drug used to treat the symptoms of thyroid eye disease (TED). This is an autoimmune disease where the immune system attacks the eye muscles and fatty tissues behind the eye causing them to stay inflamed. The constant inflammation typically causes the eyes to stay swollen and obstructs vision.

In the summer of last year, patients who were given this drug started to experience severe hearing damage (or tinnitus) and began filing product liability lawsuits against the manufacturer. In two clinical trials prior to FDA approval, hearing impairment was reported in most of the patients. The most common hearing symptoms were subjective hearing loss (n=6, 23 %), tinnitus (n=7, 27 %), ear plugging sensation (n=3, 12%), autophony and unusually loud hearing of a person’s own voice (29%).  The hearing symptoms developed after an average of 3.6 infusions. Of the 17 patients with new hearing symptoms, four had new or worsening sensorineural hearing loss, from damaged hair cells in the inner ear.  Three patients had a eustachian tube disorder.  After 3-6 months, the symptoms improved. 

thyroid eye disease (TED)

Tepezza FDA Approval

During Horizon Therapeutic’s (the manufacturer of Tepezza) U.S. Food and Drug Administration (FDA) approval process, they claimed that the hearing loss side effect only occurred in 10% of patients and that the loss is “temporary and generally of limited duration.” This was not consistent with the two clinical trials stated earlier, or with the tests ran by the Endocrine Society which saw hearing damage in 65% of patients that were given the drug.

The plaintiffs involved in these lawsuits claim that Horizon Therapeutics did not adequately warn about the risks of hearing loss from Tepezza. They claim they (and their doctors) were unaware of the potential harm that could be caused by the drug. They also claim the drug has a detective design.

IV infusion

Earlier this month a study was released from Stanford University that showed a more of a correlation between Tepezza injections and hearing loss. The case involved a 64-year-old woman who stopped using the drug due to significant hearing loss after 4 infusions, along with other adverse side effects. After lowering the dosage, however, the authors suggest that teprotumumab (Tepezza) can be effective for some patients with moderate to severe thyroid eye disease if the right amount of the drug is administered.

On April 14th , Horizon Therapeutics announced that the FDA approved an update to the Indications and Usage section of the label of Tepezza to specify its use for  the treatment of thyroid eye disease (TED) regardless of disease activity or disease duration. This could potentially increase the number of patients exposed to the side effects of this drug. This new label seems to warn against infusion reactions, menstrual disorders, increased blood glucose levels and hearing impairment. However, no further details are mentioned to point out the severity of the hearing loss side effect.

Have you been exposed to Tepezza injections?

At Fleming, Nolen & Jez, our product liability lawyers have dedicated their careers to fighting for the rights of injured victims throughout the United States. If you have thyroid eye disease (TED) and suffered serious hearing loss or hearing damage from Tepezza injections, you may be able to file a lawsuit to secure the compensation you deserve. Contact us today to speak with a member of our legal team to review your case information.

Stay Connected

More Blogs