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Horizon failed to warn of the dangerous side effects of Tepezza

In January 2020, Tepezza (also known as teprotumumab-trbw) was the first prescription drug approved by the U.S. Food and Drug Administration to treat thyroid eye disease (TED), a rare autoimmune condition associated with hyperthyroidism.

In August 2022, an Arizona resident (Daniel Weibel) filed a Tepezza lawsuit against Horizon Pharmaceuticals, claiming that his permanent hearing loss is a consequence of receiving Tepezza treatment between June 2020 and September 2020.

According to the complaint, neither the plaintiff nor his physician was aware of the risks of hearing loss or tinnitus. This was the first lawsuit to be filed against the drug's manufacturer, but more than probable, not the last one.

The link between the use of Tepezza infusion and hearing impairment symptoms continues to gain attention and raise questions about the safety of the drug.

Why was Tepezza approved by the FDA?

Thyroid eye disease (TED) is a rare autoimmune condition, which up until Tepezza, had no FDA-approved prescription drug as a treatment. A promising new drug in terms of efficacity in the treatment of TED, Tepezza was approved with an "orphan status". This special status provides incentives to assist and encourage manufacturers to develop drugs for the treatment of rare orphan diseases (conditions or diseases that affect less than 200,000 people in the United States). Orphan drug designation involves incentives such as:

  • tax credits for qualified clinical trials
  • exemption from user fees
  • seven years of market exclusivity after approval

Horizon Pharmaceuticals (also known as Horizon Therapeutics) made good use of the opportunities given by the orphan drug designation of Tepezza and aggressively marketed the drug. Initially, this innovative novelty drug was well-received on the market. However, within a year after the drug was introduced to the pharmaceutical market, studies started to reveal alarming data about a possible link between hearing loss or tinnitus and the use of Tepezza.

Adverse reactions of Tepezza that Horizon warned about

In the Prescribing Information for Tepezza, Horizon Pharmaceuticals warns about a number of adverse effects Tepezza may have and, based on data from their own clinical trials, lists the adverse effects that may occur in 5% or more of the patients (risk of occurrence in descending order):

  • muscle spasms 25%
  • nausea 17%
  • alopecia 13%
  • diarrhea 12%
  • fatigue 12%
  • hyperglycemia 10%
  • hearing impairment 10%

For hearing impairment, there is a note that details possible impairments saying it includes deafness, eustachian tube dysfunction, hyperacusis, hypoacusis, and autophony.

Even at a quick glance, it is evident that in this list, hearing impairment appears as a minimized risk.

High rate of hearing loss issues as an adverse effect of Tepezza according to a Stanford University study

Only a year after Tepezza was approved by the FDA, a small study conducted by a group of researchers at Stanford University and presented at the 2021 annual meeting of the Endocrine Society revealed that the risk of developing hearing loss health injuries after Tepezza infusion treatment might be far greater than warned by the manufacturer. Horizon warned about a risk of 10%, but this study found the rate being far greater, reaching up to 65%. Labeled as mild and reversible by the Tepezza manufacturer, hearing loss health injuries are shown by the study to be potentially severe, and some of them even permanent.

Patients who participated in the study were observed for a follow-up period of 3 months after Tepezza infusion treatment was ended. The study concludes that a 3-month period is too short for accurate assessment and that further studies are necessary in order to fully assess the reversibility/permanency of hearing loss issues.

What otologic symptoms may Tepezza patients develop?

In addition to the risk of hearing loss and tinnitus, according to other studies that were published recently, patients who received Tepezza infusion treatment are at a high of developing one or more of the following hearing-related health injuries:

  • the sensation of plugged ear
  • muffled hearing
  • autophony (an unusually loud perception of the patient's own voice or breathing)
  • damage to the inner ear
  • patulous eustachian tube
  • sensorineural hearing loss

Though Horizon Pharmaceuticals states that no punitive damage can be claimed related to Tepezza because doctors and users were warned about hearing loss as a possible adverse effect, the reality is that the manufacturer failed to accurately warn about the high risk of hearing loss associated with the Tepezza infusions. Accepting Tepezza treatment, knowing that there is a relatively small risk of reversible hearing loss involved, is a completely different situation as opposed to where treatment is accepted without the knowledge that there might be a high risk of permanent hearing loss as an adverse effect.

Tepezza claims do have a statute of limitations, so it is crucial that seek legal advice soon as your hearing loss diagnosis is established.

What do to if you received Tepezza infusion treatment and you now suffer from hearing loss or tinnitus?

Reach out to us at Atraxia Law and seek lawful compensation for your hearing-related injuries. We have an experience of over three decades in handling defective drug claims. Determining eligibility is a relatively quick and easy process. If you meet the preliminary requirements of participating in a Tepezza claim, we can and will help you navigate through the laborious and demanding process of claiming rightful compensation.