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Tepezza Lawsuit 2024 Update | Hearing Loss & Thyroid Eye Disease

Recent studies have linked the new thyroid eye disease medication Tepezza (teprotumumab) to an increased risk for irreversible hearing loss, hypoacusis (reduction in hearing), tinnitus (ringing in the ears), and other serious side effects.
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Update: First Tepezza Hearing Loss Lawsuit Alleges Horizon Failed to Warn of Hearing Risks

In the initial legal action concerning side effects associated with the thyroid eye disease treatment Tepezza, an Arizona resident is asserting that Horizon Pharmaceuticals Inc. neglected to disclose to regulators and the public that Tepezza could lead to permanent hearing loss and tinnitus (ringing in the ears).

Daniel Weibel, the plaintiff, contends that Horizon obtained FDA approval for Tepezza by withholding crucial data, analyses, and other pertinent information indicating that patients using the medication might suffer significant hearing-related complications. According to the Tepezza lawsuit, Weibel experienced irreversible hearing loss after undergoing Tepezza treatment for several months in 2020.

Furthermore, the plaintiff claims that Horizon has neglected ongoing research into Tepezza and has not issued warnings about the necessity for regular audiological monitoring for users of the drug despite numerous studies clearly demonstrating its potential to cause permanent hearing issues.

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.

As stated by the United States Courthouse, 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 [1].

What is Tepezza?

According to the U.S. Food and Drug Administration notice published in 2022, 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 [2]. The drug is injected once every 3 weeks until patients have received 8 infusions total.

Tepezza was approved by the FDA in January 2020 and is made by Horizon Pharmaceuticals.

What’s the Problem?

As stated in the FDA notice from 2023, there have been multiple reports of permanent 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 [3].

In reality, the FDA only approved Tepezza by giving it the so-called “orphan status”, which indicated that this was the drug that still needed to go through research before its efficacy was finally proven. This is common practice for drugs that treat rare conditions but still have no effective treatment alternatives.

Among the thousands of patients included in this 19-month analysis (Jan. 2020 – Aug. 2021), 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. FDA stated.

Tepezza Side Effects May Include Hearing Loss: Study

Another study from 2021, conducted by the Endocrine Society, indicates that side effects of Tepezza may be causing hearing problems in 65% of all patients who take the drug [4].

Researchers from Stanford University presented their findings at a virtual annual meeting of The Endocrine Society, reporting hearing problems, such as the ringing of the ears, autophony, a sensation of the ears being plugged, and permanent 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 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.

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 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
  • Nausea
  • Hair loss
  • Diarrhea
  • Fatigue
  • High blood sugar
  • Dry skin
  • Change in taste
  • Headache

Tepezza Hearing Loss Lawsuit Case Reports

  • According to a 2021 study by the National Institute of Health, one of the first known cases of Tepezza hearing loss or tinnitus, a 61-year-old woman with Graves Ophthalmopathy presented with bilateral hearing loss, sound distortion, and tinnitus following treatment with Tepezza [5]. 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.
  • In the report of the National Center for Biotechnology and Information from 2022, a multi-institutional focus group looked at 4 cases of Tepezza hearing loss identified among 3 clinicians who had treated 28 patients [6]. 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?

According to Penn Medicine, 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 [7]. 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?

According to the Ophthalmology Times, the original Tepezza warning label indicates in Section 6 that temporary hearing loss occurred in patients during clinical trials [8]. 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 the Tepezza hearing loss may be irreversible.

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The Pharmaceutical Litigation Group at Schmidt and Clark, LLP law firm is an experienced team of jury trial lawyers that focus on the representation of plaintiffs in Tepezza Hearing Loss Lawsuits. We are handling individual litigation nationwide and currently accepting new Tepezza lawsuit cases in all 50 states.

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