Earlier Versions of Tepezza Prescribing Information Document Did Not Include Hearing Loss Side Effects
Finally, in mid-July 2023, the Tepezza drug label now includes a warning about the risks of Tepezza-related hearing impairment. As background, in January 2020 Tepezza received FDA approval for the treatment of thyroid eye disease (TED), which is also referred to as Graves' disease, Graves' eye disease (GED), Graves' orbitopathy, and Graves’ ophthalmopathy.
In the current Tepezza Full Prescribing Information (Revised: July 2023) document, we point out this newly added subsection:
5.4 Hearing Impairment Including Hearing Loss
TEPEZZA may cause severe hearing impairment including hearing loss, which in some cases may be permanent. Assess patients’ hearing before, during, and after treatment with TEPEZZA and consider the benefit-risk of treatment with patients.
Cases of Tepezza-related hearing impairment had been reported well before this July 2023 Tepezza drug label change, and one wondered when there would finally be warnings about Tepezza hearing loss side effects. For more about that situation, we refer you to our December 2022 post, "Tepezza Hearing Loss: Cases of This Drug Side Effect Reviewed in Various Medical Journal Articles", from which we get the following:
We recently wrote about Tepezza hearing loss cases in this October 2022 article, "Tepezza Hearing Side Effects Include Deafness, Sound Sensitivity, and Tinnitus, Resulting in Tepezza Drug Injury Lawsuits". Therein we noted that case reports in medical journal articles show that Tepezza (teprotumumab) has been linked to hypoacusis, hyperacusis, autophony, and other hearing problems, which sometimes may be irreversible and permanent. We went on to point out that the (then) current Tepezza Full Prescribing Information (Revised: October 2021) document does not include any mention of hearing side effects in the "Warnings and Precautions" section nor in the "Adverse Reactions" section. And that is still the situation with the updated Tepezza Full Prescribing Information (Revised: December 2022) document that came out today.
Strictly Confidential, No Obligation.
We are investigating cases of Tepezza-related hearing impairment as possible Tepezza drug injury lawsuits. In more detail, those Tepezza lawsuits involve cases where the patient, while using Tepezza, started to experience "new" hearing problems, such as:
- Hypoacusis: hearing loss ranging from impairment to deafness
- Sensorineural Hearing Loss (SNHL): type of hearing loss resulting from damaged hair cells in the inner ear
- Hyperacusis: sound or noise sensitivity that makes it hard to deal with everyday sounds
- Tinnitus: ringing in the ears in the absence of an external source
- Autophony: unusually loud hearing of one’s own voice, breathing, and other bodily sounds
- Eustachian Tube Dysfunction: sensations of ears being "plugged" or "full" resulting in muffled hearing
If you or someone you know experienced Tepezza-related hearing impairment and is interested in possibly getting legal compensation, we encourage you to submit a Drug Injury Case Evaluation Form online — it is free, confidential, and there is no obligation. These Tepezza drug injury cases would be filed against the pharmaceutical companies which are responsible for Tepezza, not your doctors.
DrugInjuryLaw.com: Medical & Legal Information About Drug Side Effects (Website content is written by Tom Lamb)
Drug Injury Case Evaluation - Free. Confidential. No Obligation. (Attorney Tom Lamb does all case reviews)