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.
However, 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. It is the sole responsibility of the drug's manufacturer to warn properly and accurately about the health risks involved with using Tepezza.
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:
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:
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.
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.
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:
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.
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 your eligibility must be assessed.
At Atraxia Law, we have vast experience in pursuing defective drug claims. We strongly encourage you to seek out our assistance to increase your chances of getting lawful compensation for your Tepezza-related health damages.