Update: First Tepezza Lawsuit Alleges Horizon Failed to Warn of Hearing Risks
In the first lawsuit filed over side effects linked to the thyroid eye disease medication Tepezza, an Arizona man is alleging that Horizon Pharmaceuticals Inc. failed to alert regulators and the general public that Tepezza can cause permanent hearing loss and ear ringing (tinnitus).
Plaintiff Daniel Weibel claims that Horizon gained FDA approval for Tepezza by withholding raw data, analyses and other significant information indicating patients who used the drug could suffer significant hearing-related harms. Weibel developed permanent hearing loss after taking Tepezza for several months in 2020, according to the lawsuit.
Plaintiff further alleges that Horizon has also failed to continue researching Tepezza and issue warnings about users' need for regular audiological monitoring while taking the drug "despite study after study providing clear evidence" that it can cause irreversible hearing problems.
"Tepezza is defective and unreasonably dangerous to [Weibel] and other consumers regardless of whether [Horizon] had exercised all possible care in its preparation and sale," the lawsuit states.
The case is: Daniel Weibel v. Horizon Pharmaceuticals Inc., case number 1:22-cv-04518, in the U.S. District Court for the Northern District of Illinois.
What is Tepezza?
Tepezza (generic: teprotumumab) is used to treat thyroid eye disease, which can cause eyes to be dry, watery or red, and can cause eyes to bulge and cause double vision, as well as other vision problems. The drug is injected once every 3 weeks until patients have received 8 infusions total.
Tepezza was approved by the U.S. Food and Drug Administration (FDA) in January 2020, and is made by Horizon Pharmaceuticals.
What's the Problem?
Since its approval, there have been multiple reports of irreversible hearing loss with Tepezza. Horizon conducted a post-marketing study on thousands of patients which found that about 10% experienced hearing loss, the majority of which were mild to moderate and reversible, but the study did not differentiate.
“Among the thousands of patients included in this 19-month analysis (Jan. 2020 - Aug. 2022), approximately 10% of all cases reported to the safety database have included a hearing-related event. The most frequently reported hearing event was hypoacusis (reduction in hearing), followed by tinnitus (ringing in the ears). The mean age of the patient, where known, was 59.3 years."
Tepezza Side Effects May Include Hearing Loss: Study
Another study  indicates that side effects of Tepezza may be causing hearing problems in 65% of all patients who take the drug.
Researchers from Stanford University presented their findings at a virtual annual meeting of The Endocrine Society, reporting hearing problems, such as ringing of the ears, autophony, a sensation of the ears being plugged, and total hearing loss in Tepezza users.
Specifically, the study's authors observed 26 patients who were given at least 4 infusions of Tepezza. Of these, 17 patients, or 65%, reported developing hearing problems. Of those, six, or 23%, reported suffering hearing loss; seven, or 27% developed tinnitus, a ringing in the ears; and three, or 12%, reported feeling an ear plugging sensation.
Additionally, 29% of test subjects said they developed autophony, where their own voices sounded unusually loud to themselves.
The hearing problems from Tepezza appeared to develop after an average of 3.6 infusions, according to the researchers. Four of the patients who reported problems had sensorineural hearing loss, which occurs when hair cells in the inner ear become damaged.
The study's authors advised doctors to become more aware of the potential hearing issues when prescribing Tepezza, and recommended new patients be screened before taking it. The researchers also advised doctors to conduct baseline audiogram testing.
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Tepezza Side Effects
- Hearing loss (moderate to severe/reversible and irreversible)
- Sensorineural hearing loss
- Tinnitus (ringing in the ears)
- Hypoacusis (reduction in hearing)
- Autophony (enhanced perception of one's own sounds, typically voice and breathing)
- Infusion reactions
- Worsening of inflammatory bowel disease
- High blood sugar
- And more
Other more moderate side effects of Tepezza may include:
- Muscle spasm
- Hair loss
- High blood sugar
- Dry skin
- Change in taste
Tepezza Case Reports
- In one of the first known cases of Tepezza-induced irreversible hearing loss, a 61-year-old woman with Graves Ophthalmopathy presented with bilateral hearing loss, sound distortion, and tinnitus following treatment with Tepezza. An audiogram showed mild sloping to moderately severe hearing loss. Repeated audiometry was obtained 4 months after cessation of Tepezza and treatment with oral corticosteroids was unchanged.
- A multi-institutional focus group looked at 4 cases of Tepezza-associated hearing loss identified among 3 clinicians who had treated 28 patients. The group concluded that Tepezza may cause a spectrum of potentially irreversible hearing loss ranging from mild to severe, likely resulting from the inhibition of the insulin-like growth factor-1 and the insulin-like growth factor-1 receptor pathway.
What is Thyroid Eye Disease?
Thyroid eye disease – also known as Graves’ Orbitopathy, Ophthalmopathy, or simply 'TED' – is an autoimmune condition in which the eye muscles, eyelids, tear glands and fatty tissues behind the eye become inflamed. This can cause the eyes and eyelids to become red, swollen and uncomfortable and the eyes can be pushed forward (‘staring’ or ‘bulging’ eyes).
In most patients, the same autoimmune condition that causes TED also affects the thyroid gland, resulting in Graves’ disease. Graves’ disease most commonly causes thyroid overactivity (hyperthyroidism) but can also rarely cause thyroid underactivity (hypothyroidism). TED can occur in people when their thyroid is overactive, underactive or functioning normally. It can also occur after treatment for Graves’ disease.
Is There a Hearing Loss Warning on the Tepezza Label?
The original Tepezza warning label indicates in Section 6 that temporary hearing loss occurred in patients during clinical trials. However, it now appears that Horizon represented to the FDA that the hearing loss was reversible. There is nothing in the labeling or FDA approval package discussing that Tepezza hearing loss may be irreversible.
Get a Free Tepezza Lawsuit Evaluation With Our Lawyers
The Pharmaceutical Litigation Group at our law firm is an experienced team of jury trial lawyers that focus on the representation of plaintiffs in Tepezza Lawsuits. We are handling individual litigation nationwide and currently accepting new Tepezza side effects cases in all 50 states.
Free Confidential Tepezza Lawsuit Evaluation: Again, if you or a loved one suffered from Tepezza side effects, you should contact our law firm immediately. You may be entitled to financial compensation by filing a Tepezza lawsuit and our lawyers can help.