What You Should Know About Using Tepezza for Thyroid Eye Disease

Tepezza (teprotumumab) is a novelty infusion drug manufactured by Horizon Pharmaceuticals.

It was approved by the U.S. Food and Drug Administration (FDA) in January, 2020.

The Tepezza infusion is the first and, so far, the only approved treatment for thyroid eye disease (Grave's eye disease), which is a progressive autoimmune disorder associated with hyperthyroidism.

What Is Thyroid Eye Disease?

Thyroid eye disease (TED), sometimes also mentioned as Grave's disease, is a rare health condition, a progressive autoimmune disorder linked to a hyperactive thyroid gland - about 90% of TED patients have hyperthyroidism. In thyroid eye disease, the immune cells attack the thyroid gland as well as the fatty tissues around the eyes, causing inflammation and swelling.

Risk factors for TED include:

• genetics and family history
• sex (compared to men, women are more prone to developing TED)
• smoking (the risk associated with smoking is directly proportional to the number of cigarettes smoked on a daily basis)
• treatment with radioactive iodine treatment (often administered as a treatment for Grave's hyperthyroidism)

Not all TED patients present visible symptoms, but on average, about half of the patients suffering from TED present at least one, but often more, of the following symptoms:

• bulging of the eyes
• compressive optic neuropathy (damage that occurs when the optic nerve is compressed)
• double vision
• dry eyes
• eye redness
• eyelid retraction
• increased tearing
• sensitivity to bright lights
• ulcerations of the cornea (caused by the incomplete closure of the eyelids)

TED is a rare autoimmune disease, which was shown in a study published in 1994 to have an incidence rate of 19 in 100,000 people per year. As is sometimes the case with rare diseases, the FDA approves treatment drugs under special circumstances, where these drugs are given an "orphan status" designed to encourage manufacturers to develop drugs for rare diseases.

What Is Tepezza (Teprotumumab)?

A newly marketed infusion drug - approved by the FDA in January 2020 - Tepezza is an "orphan status" drug developed for the treatment of TED (thyroid eye disease). Tepezza is a promising drug in terms of efficacity for the treatment of TED. The drug is administered as an IV (intravenous) infusion, 1 injection in 3 weeks, and a total of 8 infusions complete a round of treatment.

Unfortunately, some of the adverse effects, namely those related to hearing loss, present a significantly higher risk than what the manufacturer initially warned about. Based on two clinical trials conducted before the FDA approval, Horizon Pharmaceutics, the company that produced and introduced Tepezza to the market, warned that treatment with the drug may carry a risk of hearing loss in about 10% of the patients. A small study by the Endocrine Society presented at the beginning of 2021 showed that hearing loss risks can be significantly higher, reaching as much as 65%.

This alarmingly high rate of hearing loss incidence as a result of treatment with Tepezza calls for greater awareness on the patients' side and for accountability on the manufacturer's side.

What Are the Otologic Symptoms Associated with the Use of Tepezza Infusion?

Symptoms of hearing problems may already occur after the first infusion of Tepezza, however, according to the findings of the study of the Endocrine Society, the average occurrence period is after 3.6 infusions. The drug's manufacturer deemed otologic adverse effects as reversible, but unfortunately, the study showed that this is not always the case. Some of the hearing loss issues persist even three months or longer after the last infusion of Tepezza treatment was received.

Adverse effects that affect hearing as a result of Tepezza infusion treatment include one or more of the following:

• autophony (a heightened perception of one's voice and breathing sounds)
• hearing loss
• muffled hearing or plugged ear sensation
• patulous eustachian tube (a condition in which the channel responsible for regulating the air pressure around the ear drum remains open, as opposed to opening occasionally, when needed)
• ringing in the ear (tinnitus)
• sensitivity to sound
• sensorineural hearing loss (hearing loss caused by damage to the hair cells in the inner ear)

Since hearing loss impairment has an impact on the quality of life and the earning ability of the patient, and it may also involve high medical costs for its treatment, it is too great of a price for TED patients to pay.

Are You Eligible for a Tepezza Claim?

It is the sole responsibility of the drug's manufacturer to warn properly and accurately about the health risks involved with using Tepezza. Horizon Pharmaceuticals failed to give a proper estimate of the hearing loss risks associated with the Tepezza infusion treatment, and it also minimized the rate of reversibility of the otologic adverse effects. For this reason, if you suffer from hearing loss after being treated with Tepezza infusion, you might be eligible for filing a Tepezza claim. Each individual case has its specificities, so eligibility must be assessed by a knowledgeable Tepezza lawyer, but as a general guideline, if you fulfill the two criteria below, your chances for filing a Tepezza claim are high:

• no hearing loss history prior to the Tepezza infusion treatment
• diagnosed hearing loss or other otologic symptoms following the treatment with Tepezza infusion

At Atraxia Law we have vast experience of over twenty years in pursuing defective drug claims. We strongly encourage you to seek out legal assistance and increase your chances to get lawful compensation for your Tepezza-related health damages. Call us and find out more about your eligibility!