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FDA adds hearing loss and impairment warnings to TEPEZZA label


With lawsuits looming over the issue, the FDA has updated the label on Horizon Pharmaceutical’s drug for thyroid eye disease to include risks associated with hearing loss.

(Image Credit: AdobeStock/ra2 studio)

(Image Credit: AdobeStock/ra2 studio)

The US Food and Drug Administration (FDA) has updated the warning label on Horizon Pharmaceutical’s TEPEZZA to include hearing impairment or loss.

The label now includes a warning for “hearing impairment including hearing loss” as one of the “major recent changes” under the warnings and precautions of the drug. Hearing impairment or loss is 1 of 4 other warnings or precautions on the label including infusion reactions, exacerbation of preexisting inflammatory bowel disease, and hyperglycemia.

The newly added warning from the FDA says “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.”1

This warning is added just a under month after the drug was approved by the Brazilian Health Regulatory Agency (Agência Nacional de Vigilância Sanitária - ANVISA) in Brazil for the treatment of treatment of thyroid eye disease (TED).

Horizon Pharmaceuticals has been facing a growing number of lawsuits over the complications involving hearing impairment/loss from TEPEZZA injections that claim the side effects were not adequately disclosed on the initial warning labels for the drug.

Permanent hearing loss has been linked to TEPEZZA since its clinical trials, but a warning for the side effect has just recently been added by the FDA.

Recently, a study published in the medical journal Endocrine Practice showed that 16% (20) of 121 patients reported adverse events related to hearing from TEPEZZA. Twelve of the 20 reported tinnitus, hearing loss/impairment, hyper/hypoacusis, autophony, or eustachian tube dysfunction.2

  1. US Food and Drug Administration. Tepezza Prescribing information. Accessed July 24, 2023. https://www.hzndocs.com/TEPEZZA-Prescribing-Information.pdf
  2. Terry J. Smith, MD, Qianhong Fu, MS, Robert J. Holt, PharmD, MBA. Hearing-Related Adverse Events and Quality of Life Assessments in Thyroid Eye Disease Patients Treated with Teprotumumab. Endocrine Practice. DOI: https://doi.org/10.1016/j.eprac.2023.03.245
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