The FDA Adds Hearing Loss Warnings to Tepezza Label

After years of complaints and lawsuits from patients and medical communities regarding the lack of warning from the drug maker about the high risks associated with their new-generation thyroid eye disease treatment, finally, the Food and Drug Administration (FDA) has taken steps to warn Tepezza® users. This past July, the FDA announced they are updating the drug’s warning label, which will now disclose the side effects Tepezza may cause.

Tepezza®, developed by Horizon Therapeutics, is the first prescription drug approved by the FDA to treat the condition known as Graves' eye disease or thyroid eye disease (TED). TED is a condition that occurs when the eye muscles, tear glands, eyelids, and the fatty tissue behind the eyes become inflamed. The inflammation is triggered through an abnormal autoimmune response and can cause the eyes to swell and obstruct vision. Tepezza® works by blocking a protein called IGF-1R that is believed to be the cause of TED. 

The new warnings update comes after former users of the drug, as well as members of the medical community, filed product liability lawsuits against Horizon. These lawsuits claimed patients were left with irreversible hearing problems from Tepezza® side effects, which were not properly labeled or disclosed on the initial warning labels. Plaintiffs believe they could have avoided hearing damage had Horizon Therapeutics provided patients and doctors with earlier warnings regarding the importance of monitoring hearing before and during treatments.

Study Proves Tepezza® Is 6 Times More Likely To Cause Hearing Loss

Approved by the FDA in January 2020, Tepezza® is the only drug known to treat TED. Although Tepezza® was considered a niche treatment, Horizon Therapeutics quickly pushed the drug to “blockbuster” status shortly after it was approved by the FDA, where sales exceed $1 billion per year. However, only a year into its release, concerns over the drug makers' research quickly came to light as patients and doctors began to notice hearing side effects.

A 2021 study found that patients taking Tepezza® were at a 65% higher risk for developing temporary and even permanent hearing issues compared to Horizon’s original clinical trials, which only documented that 10% of their patients reported hearing issues. This means patients who were taking  Tepezza® to treat TED were over six times higher than the original estimated risk of hearing loss disclosed by Horizon during the FDA approval process.

Lawsuits Filed Against Horizon Led to Updated Warning Labels

Since discovering the issues behind patients using Tepezza®, multiple lawsuits have been filed against Horizon Therapeutics, alleging the drug maker knew or should have known that Tepezza® causes hearing loss. According to the studies, Tepezza® works by blocking a protein called IGF-1R, which can harm the hair cells in the ear. The hair cells in the inner ear detect sound waves and transmit them to the brain, allowing us to hear and maintain balance. If the hair cells in the inner ear are damaged, it can lead to hearing loss and other auditory issues.

The lawsuits claim that Horizon used less than one hundred patients during their clinical trial and failed to conduct proper follow-up or disclose the potential side effects. With the small amounts of information they had, the drug company decided to move forward with Tepezza® and submitted the drug to the FDA for approval. This information alone was enough to indicate that Horizon Therapeutics attempted to ignore the issues with the drug and placed its desire for profits before the safety of its consumers. The lawsuits also point out the aggressive marketing used by the drug company that pushed the use of the drug, which helped make sales double to $1.66 billion during its second year on the market in the U.S. 

As of July 2023, thanks to a recent study published in the medical journal Endocrine Practice that found more than 16% of those who took  Tepezza® suffered hearing problems that included hearing loss, tinnitus, autophony, and eustachian tube dysfunction, as well as the added pressure of lawsuits and complaints behind the TED treatment drug, the FDA has officially released a new version of the Tepezza® warning label. This newly updated label comes with an addition to the warnings and precautions section. This section covers the risk of severe hearing loss that may be permanent in some cases. The new label also indicates doctors should assess patients’ hearing before, during, and after Tepezza infusions.

Victims of Tepezza® Are Filing Lawsuits Now

Victims of Tepezza® are filing lawsuits against Horizon Therapeutics after taking the prescription drug and suffering from permanent hearing loss. According to the lawsuits, the label on the drug did not adequately warn patients or doctors about the potential risk for hearing loss, nor did it warn how these issues could be permanent. If you or a loved one have suffered temporary or permanent hearing loss after taking  Tepezza® to treat TED, you may be entitled to financial compensation. For more information, contact a Morgan & Morgan attorney for a case evaluation.