Prescription Drug Tepezza Linked to Hearing Loss and Tinnitus
Burg Simpson is investigating potential product liability claims against the manufacturer of Tepezza related to hearing loss.
What is Tepezza?
Tepezza (teprotumumab-trbw) is a prescription drug marketed in the United States by Horizon Therapeutics USA, Inc. (“Horizon”). Tepezza was approved for marketing by the FDA in January 2020 for the treatment of Thyroid Eye Disease (TED), also known as Graves’ eye disease. Tepezza is administered through an IV infusion.
July 2023 Update: Horizon Changes Tepezza Label To Warn of Permanent Hearing Impairment
On July 17, 2023, Horizon updated the drug label for Tepezza to include warnings of hearing impairment, including hearing loss, caused by the drug. The Warnings and Precautions section of the label now states “Tepezza may cause severe hearing impairment including hearing loss, which in some cases may be permanent.” The label advises doctors administering the drug to “assess patients’ hearing before, during, and after treatment with Tepezza and consider the benefit-risk of treatment with patients.”
Horizon’s update to the Tepezza label comes after numerous adverse advents were reported to the FDA in the last three years since approval of the drug. The FDA adverse event data for Tepezza includes reports of deafness, hypoacusis (hearing loss or decreased sensitivity to sound stimuli), tinnitus (ringing or buzzing in ears), and autophony (perception that your voice is too loud or is echoing in your ears).
What Injuries are Caused by Tepezza?
Several reports have been published by concerned medical professionals describing patients who suffered serious and potentially irreversible hearing impairment side effects after using Tepezza. Such hearing impairments include:
- Hearing Loss
- Tinnitus (ringing or buzzing noise in your ears)
- Hypoacusis (decreased sensitivity to sound stimuli)
- Autophony (perception that your voice is too loud or is echoing in your ears)
Hundreds of hearing impairment adverse events associated with the use of Tepezza have also been reported to the FDA. A new study published in early 2022 found that over 81% of the patients in the study taking Tepezza developed new hearing impairment symptoms. Several of these patients continued to suffer from hearing loss even after the 6-month study period. Despite all this new information, Horizon continues to sell Tepezza and has not added any further warnings or guidance to the drug’s label concerning the risk of hearing impairments.
Horizon Failed to Warn about Tepezza’s Risks
Horizon received FDA approval for Tepezza after performing two small clinical trials involving a total of only 84 patients who received the drug. Horizon reported that less than 10% of the test patients experienced any hearing impairment symptoms. It further represented that of these hearing related side effects, all were mild/moderate and temporary. However, since Tepezza’s approval, new information has come to light that indicates the risk of suffering hearing impairment after using Tepezza may be more common and severe than what Horizon previously reported.
Contact Burg Simpson Today
If you or a loved one have been diagnosed with hearing loss, deafness, tinnitus, hypoacusis, autophony, or any other serious hearing impairment after using Tepezza, contact the experienced product liability attorneys at Burg Simpson today. Our award winning team of compassionate lawyers has spent years fighting drug companies and others who refuse to take responsibility for the harm they cause. Let us fight for you. Call 1-888-895-2080- or fill out our contact form for a free, no-obligation consultation today.