Tepezza Production History

Tepezza—also known under the generic name teprotumumab—is a drug that has been prescribed to treat a rare condition called thyroid eye disease. To date, it is the only drug approved to treat this condition, which can cause a patient’s eyes to bulge outward due to inflammation in the tissue behind the eye.

After a number of early trials, Tepezza was approved for the treatment of thyroid eye disease in the United States in 2020. Not long after, a number of published studies linked the drug to tinnitus and hearing loss. While there is not currently any recall, an experienced dangerous drug attorney can speak with you about the potential for a lawsuit.

Early Trials for Tepezza

Tepezza was not originally designed to treat thyroid eye disease. At first, this medication was thought to be useful in treating a range of serious conditions, including breast cancer and Hodgkin’s lymphoma. The first two trials—which concluded in 2009—did not lend the results needed for the drugs to go into production to treat those diseases.

However, later clinical trials reflected that the drug was effective in treating thyroid eye disease. In the two initial trials, Tepezza succeeded in reducing the symptoms of this disease for 71 and 83 percent of trial participants, respectively.

FDA Approval

On January 21, 2020, the U.S. Food and Drug Administration (FDA) approved the drug known as Tepezza for the treatment of thyroid eye disease among adults. This marked the first time the FDA had approved a drug prescribed for that specific condition. This fact is important, as it lowered the testing standards necessary to receive approval.

The manufacturers of Tepezza received a number of special privileges and grants from the FDA during this process. The FDA granted priority review and fast-tracked the drug, ensuring a decision came sooner than was normal. It was also designated as a breakthrough therapy, which is a status that fast-tracks approval for drugs that are believed to substantially improve treatment for a serious condition.

Concerning Studies

Not long after Tepezza was made available to the public, reports of harmful side effects became public. While the drug warned of a number of possible side effects on the packaging, those warnings did not include the risk of hearing loss or tinnitus.

August of 2022 saw the first of many lawsuits filed against Horizon Therapeutics, the manufacturers of Tepezza. The legal claim against the pharmaceutical company is based on the lack of warning of the high risk of hearing loss or tinnitus when taking the drug. To make matters worse, there are allegations that the company was aware of the risks when they failed to include them in their warnings.

Tepezza Recall Status

Despite the research that links Tepezza to long-term hearing loss and tinnitus, the FDA has not yet issued a mandatory recall for the drug. Likewise, Horizon Therapeutics has not voluntarily issued a recall. Instead, the manufacturers have downplayed the extent of these side effects, as well their duration. Tepezza is still available in the United States.

Talk to an Attorney About Tepezza and Hearing Loss You Sustained

Tepezza’s production history is concerning due to its expedited approval and lack of recall thus far. The risks to your hearing when taking this drug could be significant and long-lasting, so now is the time to seek legal counsel. Ask for a free consultation with Charles, Schlueter & Smith and discuss if you might have a claim.


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