We are available 24/7


Why did the FDA approve Tepezza?

One of the reasons that Horizon Pharmaceuticals (the manufacturer of the Tepezza infusion treatment) didn’t test the drug more rigorously and also the reason the FDA approval was greatly facilitated, is the fact that thyroid eye disease (TED) is a rare autoimmune condition, with no effective treatment option.

To this day, Tepezza infusion is the first and only treatment option for TED.

In such cases of rare conditions with no effective treatment options, FDA approval is given with an “orphan status”, which means that drugs manufactured as a treatment for these health conditions may become available on the market through a faster process than the standard approval process.

The Tepezza infusion was tested on only 100-170 people

Based on the initial clinical trials prior to the FDA approval, Horizon Pharmaceuticals estimated the possibility of hearing loss risks as an adverse effect of the Tepezza infusion treatment at around 10%. The FDA approved the Tepezza drug in January 2020. It wasn’t until a year later that a small study by the Endocrine Society presented its findings, revealing that hearing loss risks associated with the use of Tepezza infusion treatment are a lot higher than 10%, reaching up to 65%.

Whatever the circumstances, though, the manufacturer has the responsibility to properly and accurately inform patients about the health risks and possible side effects involved with the use of the drug. Failure to responsibly warn and inform is punishable by law.

The “orphan status” involves the responsibility of the manufacturer to continue studying the safety and the efficacity of the drug that obtained this status. Since later studies suggested alarmingly higher hearing loss risks as opposed to the initial warnings, it is clear that further analysis of the adverse health effects is imperative.

To determine your eligibility for a Tepezza claim, the first step is to provide evidence of your hearing loss diagnosis following a Tepezza infusion treatment. We offer our expertise in gathering and processing relevant medical documentation needed for filing and pursuing the Tepezza claim.

How Atraxia Law can help you receive compensation in a Tepezza claim

Hearing loss symptoms can seriously affect the quality of life. If the drug's manufacturer failed to issue accurate warnings about adverse effects that may permanently affect the hearing of the Tepezza user, then they should be held liable.

We have vetted a large variety of defective drug cases, and based on our extensive experience, our team at Atraxia Law is able to offer quick and effective assistance in vetting your Tepezza claim.