Side effects of Tepezza on hearing loss may qualify for compensation

Side effects of Tepezza: who is affected?

Have you been treated by Tepezza? Have you suffered from hearing problems, including permanent hearing loss?

In July 2023, the U.S. Food and Drug Administration (FDA) updated the label of Tepezza, a treatment for thyroid eye disease, to warn patients and doctors that the drug may cause hearing problems, including permanent hearing loss.

Years before the label change was finalized, drugmaker Horizon Therapeutics may have known about the risk but failed to adequately warn patients and doctors about the possibility of permanent hearing loss. As a result, patients may be denied the opportunity to make an informed decision regarding their treatment.

Patients who suffer permanent hearing loss as a result of Tepezza treatment can file a lawsuit and obtain compensation for their injuries.

Tepezza: overview

Tepezza is an infusion medication manufactured by Horizon Therapeutics and used to treat eye swelling and double vision. The medication may also treat symptoms of thyroid eye disease, such as eye pain, eye redness, and eye swelling. Thyroid eye disease is a relatively rare condition that results from Graves’ disease, an autoimmune disease involving an overactive thyroid.

Tepezza was approved by the FDA in January 2020.

Today’s approval marks an important milestone for the treatment of thyroid eye diseases, said Dr. Wiley Chambers, deputy director of the Division of Transplantation and Ophthalmology Products at the Center for Drug Evaluation and Research. of the FDA, in an approval press release.

This treatment has the potential to modify the course of the disease, saving patients from the need for multiple invasive surgical procedures by providing an alternative, non-surgical treatment option.

According to Tepezza official websiteCommon side effects of Tepezza include:

• Muscle cramps or spasms
• Nausea
• Hair loss
• Diarrhea
• Feeling tired
• High blood sugar
• Hearing problems
• Taste changes
• Headache
• Dry skin
• Weightloss
• Nail problems
• Changes in menstruation

Unfortunately, Tepezza may also be associated with a more serious side effect: permanent hearing loss.

Deafness of Tepezza

In the two studies used to approve Tepezza, hearing problems were reported in 10% of patients. A Study 2021 presented in March 2021 at the Endocrine Society annual meeting suggests that this rate could be much higher. The study, which evaluated 26 patients treated with Tepezza, found that 65% of them suffered from hearing problems. Symptoms recorded by the study included:

• Hearing loss (supported by 23% of patients)
• Tinnitus or ringing in the ears (experienced by 27% of patients)
• Sensation of blocked ears (12% of patients)
• Autophony or unusually loud hearing of one’s own voice (experienced by 29% of patients)

According to the study, hearing loss in Tepezza can take several forms. Some patients have suffered from sensorineural hearing loss, resulting from damaged hair cells in the inner ear. Others have suffered from patulous Eustachian tube, a disorder in which a canal between the middle ear and the nose and throat area remains constantly open instead of opening only to regulate air pressure in the ear.

Unfortunately, the hearing loss was permanent in some of these cases. After three months, some symptoms improved while others remained, even after stopping the medication.

In February 2022, a post-market safety analysis of Horizon Therapeutics confirmed Tepezza’s risk of hearing loss, although Horizons trials found hearing-related side effects in only 9.5% of patients.

With the results of these studies, the FDA approved a label change for Tepezza in July 2023. The new label includes a warning for hearing impairment, including hearing loss, which in some cases can be permanent.

Join an investigation into Tepezza’s hearing loss lawsuit

Although the Tepezza label change in 2023 helps warn patients and doctors of the potential risks of hearing loss, patients who have not been warned of this risk in the past may be able to file suit in justice for their hearing loss and associated injuries. Patients might not have chosen Tepezza treatment if they had known about the risks of hearing loss, but they were unable to make an informed choice because they had not been warned of these risks for years before the 2023 label change.

If you have experienced hearing loss after being treated with Tepezza, you may be eligible to participate in this Tepezza Hearing Loss Lawsuit investigation.

Please fill out the form on this page to see if you qualify for a FREE case evaluation.