Tepezza Users Often Require Second Treatment Course for Thyroid Eye Disease

Researchers have yet to investigate whether multiple courses increases the risk of Tepezza hearing loss side effects identified in other studies and case reports

The findings of a new study raise questions about the efficacy of Tepezza, a new thyroid eye disease drug that has recently been linked to an increased risk of permanent hearing loss, indicating that many patients require a second Tepezza infusion before they see any benefits from the drug.

Tepezza (teprotumumab-trbw) was just approved by the FDA in January 2020, as a biologic treatment for thyroid eye disease, which is caused by hyperthyroidism and linked to Graves’ disease, resulting in inflammation of eye muscles, eyelids, tear glands and fatty tissues behind the eye. This can lead to blurred or double vision and can cause the eyes to appear to bulge.

The FDA approved Tepezza through a fast-track Orphan Drug designation, which allowed the drug maker to introduce the injection without extensive testing, since it targeted a condition which has no other treatment available. However, a number of studies and case reports published over the last two years have identified a link between Tepezza and hearing problems, which critics indicate the manufacturer knew or should have known.

As a result of the failure to warn users and the medical community about the risk of irreversible hearing loss, the drug maker now faces a growing number of Tepezza lawsuits brought by former users, some of which experienced worsening hearing damage following multiple infusions.

Last month, the drug maker Horizon Therapeutics presented the findings of a real-world analysis of the effectiveness of Tepezza at the 91st Annual Meeting of the American Thyroid Association.

According to the findings, up to 15% of those who receive Tepezza treatment experience thyroid eye disease flare-ups.

The analysis looked at data on 5,845 people with thyroid eye disease (TED) who underwent a full, uninterrupted course of eight Tepezza infusions in 2020. Researchers then looked for those who underwent a second course of the drug before July 2022. During the two-year period, nearly five percent of Tepezza users had to undergo a second course of treatment, according to the findings.

The flare-ups are part of the progressive nature of TED, according to the researchers. They found that 15% of thyroid eye disease patients experienced flare-ups regardless of the treatment regimen they were given. Researchers are still trying to determine the cause of the flare-ups, and say some triggers appear to include pregnancy, stress, and undergoing surgery.

Tepezza Hearing Loss Side Effects

The findings come amid growing concern over the side effects of Tepezza, which studies have indicated can include permanent hearing loss and tinnitus (ringing of the ears).

Tepezza is an insulin-like growth factor 1 receptor (IGF-IR) inhibitor medication, and it is well known that IGF-I is crucial to protecting the inner ear hair cells from noise-induced hearing damage, ischemia and medication toxicity. Therefore, plaintiffs pursuing Tepezza lawsuits claim that the drug maker knew or should have known about the hearing loss risks, and withheld accurate information from the FDA, consumers and the medical community.

While the drug’s warning label does mention hearing loss as a possible side effect of Tepezza, lawsuits allege that the drug maker downplays the problems as temporary, and that many users could have avoided permanent hearing loss of instructions had been provided about the importance of monitoring hearing on Tepezza.

In a study published earlier this year in the American Journal of Ophthalmology, Stanford researchers looked at 27 patients who had received at least four Tepezza injections and followed up with them up to 40 weeks later, finding that more than 80% of patients receiving Tepezza suffered some form of hearing problems.

A review of that study, published in August 2022, found that about one-third of all patients who experienced Tepezza hearing loss still suffered problems months after receiving the injections.

The findings of this latest study could raise even more concerns about Tepezza hearing loss, as a second course of the drug may increase the risks of hearing damage. However, the link between multiple courses of Tepezza and hearing loss does not yet appear to have been explored by researchers.

Product liability lawyers are currently investigating whether individuals may be eligible for a Tepezza hearing loss lawsuit payout if they were diagnosed with tinnitus or any degree of hearing loss that was not experienced before receiving the infusion.