December 14, 2022 –San Diego, CA. The ultra-expensive thyroid eye disease drug teprotumumab, brand name Tepezza, has recently been linked to hearing loss, changes in hearing and tinnitus. This is prompting those affected to file lawsuit claims against the drug maker.
First approved by the FDA in January 2020, teprotumumab can cost patients up to $400,000 for a full 6-month treatment. This drug is used to treat thyroid eye disease (TED) also known in the medical community as Graves’ disease. This autoimmune disorder causes bulging eyes and other eye problems.
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The Endocrine Society Studies showed that 65% of patients had reported some hearing loss after using Tepezza, some of which was permanent.
This study published by The Endocrine Society in March of 2021 examined 26 patients receiving Tepezza four times per day. They reported that the findings showed 77% of those stated that they never had any hearing related issues prior to taking Tepezza.
The study also highlighted the main hearing symptoms found in the Tepezza study were:
Tepezza Hearing loss injuries as reported by patients:
Horizon Pharmaceuticals Inc. is based in Chicago, Illinois and was acquired in December 2020 by Amgen for $27.8 billion. Horizon strongly believes that its block-buster, first ever FDA approved medication for TED, teprotumumab, will reach $1 billion in sales in the US alone.
Since it is the only FDA approved medication for TED the company sees potentially huge profits and currently spends millions on TV ads.
Horizon Pharmaceuticals Inc. was aware of hearing loss and other related otologic symptoms in their clinical trials and failed to warn consumers and medical professionals. It reported that during trials, only 10% had a risk of hearing problems associated with Tepezza, however the 2021 Endocrine Society study showed as many as 65% of Tepezza users did suffer from some level of hearing loss or related hearing problems.
“Our results demonstrate a much higher percentage of teprotumumab-treated thyroid eye disease patients with new otologic symptoms than previously reported […]. Patients with baseline hearing loss should be counseled on this potential risk and strongly advised to undergo baseline audiometric testing with frequent monitoring.” [1]
If this data was made available, countless amounts of people could have re-evaluated if they should have taken this new drug.
Sadly at this time there is no FDA warning assigned to this drug, nor has the company provided a recall of Tepezza. We intend to hold Horizon Pharmaceuticals Inc. responsible for both failure to warn consumers and lack of any visual warnings on labels or packaging. Read more on the Tepezza Lawsuit.
Now that the drug has been on the market for a few years, users are now coming forth reporting various hearing issues including:
If you or someone you love has suffered any hearing loss or related hearing problem after being prescribed Teppezza we encourage you to take action now, by calling our Defective Drug lawyers at the Schmidt National Law Group at 1-800-631-5656, or contact us via the 100% secure online claims form on this page. We expect potentially large cash payouts for victims of hearing loss from Tepezza.
The process to file a Tepezza lawsuit is a simple process as follows:
Sources:
https://pubmed.ncbi.nlm.nih.gov/35227694/
https://endocrinenews.endocrine.org/increased-risk-of-hearing-impairment-with-new-ted-treatment/
https://www.fda.gov/drugs/drug-approvals-and-databases/drug-trial-snapshot-tepezza
Citation 1: Sears CM, Azad AD, Amarikwa L, et al. Hearing dysfunction after treatment with teprotumumab for thyroid eye disease. Am J Ophthalmol. February 25, 2022.
Tepezza Lawsuit page updated on 4/5/2023