Good for Treating TED, Potentially Fatal for Hearing – What We Know About Tepezza So Far

If you are among the 19 people in 100,000 affected yearly by thyroid eye disease (TED), or someone in your family or among your friends is, then you are familiar with the challenges this rare autoimmune disease comes with.

Until three years ago, there was no approved prescription drug to treat TED, so news that Horizon Pharmaceutics, who launched Tepezza (teprotumumab) in 2018, got it approved by the FDA in January 2020, found doctors and patients hopeful.

Promising Clinical Trials and Adverse Effects that Seemed Worthy of Compromise

TED, also known as Grave’s eye disease, commonly often mentioned as bulging eye disease, is a progressive inflammatory disease of the soft tissue around the eyes, associated with hyperactivity of the thyroid gland.

Signs and symptoms vary from person to person in type and severity, but it is common for people affected to have protruding, so-called bulging eyes with a specific stare. This state of disfiguration is accompanied by physical pain in the eye socket, eyelids, and eyeballs. Still, it also creates strong emotional distress, leading, in some cases, to debilitating anxiety and great difficulty in normal societal functioning.

It is no wonder that when Tepezza was introduced as an FDA-approved prescription drug, it had a warm welcome and picked the interest of many medical institutions and their patients. Tepezza infusion treatment became more widely prescribed and more readily received than the manufacturer estimated it would be, and Horizon Pharmaceutical made sky-rocketing sales from marketing the drug.

Many TED patients around the country embarked on the lengthy – one complete round of treatment consisting of 8 IV infusions of Tepezza, administered once every three weeks – and pricey journey of Tepezza infusion treatment.

Stating that the drug had no contraindications, the manufacturer warned future patients about possible adverse effects and their potential risk of occurrence based on the findings of two internal clinical trials. Adverse effects that developed in 5% or more of the patients who participated in these clinical trials were listed with the following risks or occurrences:

• 25% for muscle spasms
• 17% for nausea
• 13% for alopecia
• 12% for diarrhea
• 12% for fatigue (including asthenia)
• 10% for hyperglycemia (including blood glucose increase)
• 10% for hearing impairment (including deafness, eustachian tube dysfunction, hyperacusis, hypoacusis, and autophony)
• 8% for dysgeusia
• 8% for headache
• 8% for dry skin
• 6% for weight decrease
• 5% for nail disorder

In the Tepezza Prescribing Information, hearing-related adverse effects, placed on the seventh position in descending order of risk of occurrence, were also presented as mild and reversible, meaning that they would subside relatively shortly after the Tepezza infusion treatment has concluded.

Worrying News One Year After the FDA-approval

After several infusions, TED patients prescribed Tepezza infusion treatment experienced relief and the soothing of their symptoms. Still, it didn’t take long before the first news of alarming hearing loss risk broke.

Only one year following the FDA approval of the drug, a study presented virtually at ENDO, the annual meeting of the Endocrine Society, brought to light shocking data about how hearing loss risks could be six folds higher (reaching up to 65%) than what the manufacturer initially warned for.

The study also found that auditory symptoms were not all reversible. Some of these proved to be irreversible, causing, for example, permanent hearing loss.

65% of the patients participating in the study complained about one or more auditory symptoms, which showed up in the study with the following rates of occurrence:

• autophony (29%)
• tinnitus (27%)
• subjective hearing loss (23%)
• ear plugging sensation (12%)

Additional symptoms included sensorineural hearing loss and a patulous eustachian tube. This study drew attention to the fact that further testing is needed to gain a clearer understanding of the real danger that the side effects of the Tepezza infusion treatment pose. 

A further study published in October 2022 in the Journal of Clinical Endocrinology & Metabolism revealed that Tepezza infusion treatment carries a significant risk of hyperglycemia (also not adequately warned about by the manufacturer).

Further Sordid Findings and Lawsuits Being Filed in Federal Courts Across the Country

Weighing against each other transitional hearing loss and the chance of getting cured of TED and its painful and, in many cases, disfiguring symptoms and then opting for treatment can be called making an informed decision.

Suddenly finding yourself dealing with permanent hearing loss and the challenges of having to adjust to an altered life when you were not warned about such an outcome means you were robbed of the ability to make an informed decision.

A second study, published in February 2022 in the American Journal of Ophthalmology, came with even more worrying news and caused waves of concern mixed with shock and disbelief when its findings revealed that hearing loss risks associated with using Tepezza infusion treatment could be as high as 81.5%.

It is solely the manufacturer’s responsibility to conduct extensive, in-depth testing about possible long-term adverse effects of a drug and to adequately and accurately warn users about these risks. Horizon Pharmaceuticals failed to warn doctors and patients responsibly and can be held liable.

In fact, up until today, 34 Tepezza hearing loss lawsuits have been filed in federal courts across the United States. Still, it is a reasonable expectation to see this figure drastically increase in the coming next months.

If you suffer from Tepezza hearing loss, seek immediate legal assistance

All defective drug claims have a statute of limitations, and so do Tepezza claims. This window during which Tepezza claims can be filed is different in every state, and it can mean a period between two and four years.

No matter your situation and how Tepezza-related hearing loss or tinnitus manifest in your life, the first step to take is always finding out whether you are eligible to file a Tepezza claim. It would be best not to waste time pondering this decision alone.

Our Atraxia Law team has over two decades of expertise and experience in vetting defective drug claims. Reach out to us, and we will determine your or your family member’s eligibility through a quick and effective process. We will also help you understand what filing a Tepezza claim involves so that you can make a timely and informed decision.