Tepezza and Thyroid Eye Disease

Thyroid eye disease (TED) is a rare autoimmune disorder that affects the eyes, causing inflammation and swelling behind the eyeball.

The condition is most commonly associated with Graves’ disease, an autoimmune disorder that causes the thyroid gland to produce too much thyroid hormone.

That’s why many people may know TED as Graves’ eye disease, Graves’ ophthalmopathy, or Graves’ orbitopathy.

TED can cause a range of symptoms, including:

• Eye pain
• Redness
• Puffiness
• Dry eyes
• Light sensitivity
• Difficulty moving the eyes

Severely affected individuals may also experience the following symptoms:

• Proptosis or eye protrusion
• Diplopia or double vision
• Corneal damage
• Temporary vision loss

If left untreated, Thyroid Eye Disease can lead to permanent vision loss and disfigurement of the eyes, significantly affecting a person’s quality of life.

The condition can cause debilitating symptoms like severe eye pain, inflammation, and sensitivity to light, making daily activities challenging.

In advanced stages, it may result in bulging eyes and double vision, severely impacting the ability to see clearly and engage in normal activities.

The cosmetic changes and vision impairment associated with Thyroid Eye Disease can lead to psychological distress and a decrease in self-esteem, highlighting the importance of timely and effective treatment.

Tepezza Treatment for TED

Manufactured by Horizon Therapeutics, Tepezza (teprotumumab) is an injectable medication used to treat active thyroid eye disease and has been shown to improve symptoms and reduce inflammation in clinical trials.

The Tepezza infusion works by targeting a protein called insulin-like growth factor-1 receptor (IGF-1R), which contributes to the development of TED.

By blocking this protein, Tepezza can reduce inflammation and swelling behind the eyes, improving symptoms and preventing permanent vision loss.

Patients typically go to a hospital or infusion center to receive Tepezza infusions.

A medical professional will administer the medication through an intravenous (IV) infusion, where they will insert a needle into a vein in the hand or arm.

The infusion process can take up to 90 minutes.

In general, receiving Tepezza infusions involves completing a course of eight treatments.

Patients usually receive treatments every three weeks for a total of 24 weeks.

Doctors may adjust the treatment schedule according to individual responses and side effects.

Since the U.S. Food and Drug Administration (FDA) approved Tepezza on January 21, 2020, it has been the first and only FDA-approved medication for active thyroid eye disease.

The FDA approval of Tepezza has been a significant development for patients with chronic/low clinical activity score (CAS) TED, as there have previously been no FDA-approved treatments.

Tepezza Side Effects and Injuries

Tepezza, while effective in treating Thyroid Eye Disease, can lead to various side effects, ranging from mild to severe.

These side effects encompass a wide spectrum of physical reactions, some of which may be temporary, while others could have more lasting implications.

It is crucial to talk to your doctor and to be vigilant in monitoring for any adverse effects during and after the treatment course.

The severity of these side effects can differ significantly among individuals, with some experiencing only minor discomforts, whereas others may encounter more serious complications.

It’s important to note that while some side effects are common and expected, others, particularly those affecting hearing, have raised concerns and led to legal action.

Patients experiencing any unusual or persistent side effects are advised to seek medical attention promptly and consider legal consultation if their health has been adversely affected.

Here are common Tepezza side effects, as listed on the Tepezza website.

Muscle Spasms

One of the most frequently reported side effects is muscle spasms.

These can manifest as sudden, involuntary contractions that can cause discomfort and pain.

Muscle spasms may also affect mobility and interfere with daily activities.

Muscle spasms affected 25% of patients in clinical trials.

Nevertheless, they found this side effect manageable and often resolved with time.

Nausea

Nausea is a common side effect of Tepezza, can be mild or severe, and may make it difficult for individuals to take the medication as prescribed.

In the clinical trial, 17% of patients reported experiencing nausea after receiving the first two Tepezza infusions.

However, no patients discontinued treatment due to this side effect.

Hair Loss

Hair loss, or alopecia, is also a common side effect of Tepezza.

Hair loss can occur in different body areas, including the scalp, eyebrows, and eyelashes.

13% of patients in the clinical trial reported hair loss.

Most of them experienced mild hair thinning except for one patient who reported moderate hair loss.

Diarrhea

Diarrhea is a gastrointestinal side effect that can occur during Tepezza treatment.

This condition causes frequent, watery bowel movements that can be uncomfortable and disruptive to daily life.

In the clinical trial, 12% of patients reported experiencing diarrhea.

Almost all of them experienced mild symptoms, save for one patient who had a severe case.

Fatigue or Weakness

Another common side effect of Tepezza is fatigue or weakness.

This condition can manifest as feeling tired, weak, or having low energy levels.

In the clinical trial, 12% of patients reported experiencing this side effect.

Two patients reported moderate fatigue or weakness, while the rest experienced mild symptoms.

Hyperglycemia or High Blood Sugar Levels

Tepezza treatment can also lead to increased blood sugar levels, known as hyperglycemia.

People with high blood sugar levels may experience excessive thirst, frequent urination, and fatigue.

In the clinical trial, 10% of patients reported this side effect.

For those without diabetes, their blood sugar levels spiked higher than usual, which doctors managed throughout treatment.

Those with diabetes saw a rise in their blood sugar levels, which was manageable with medication adjustments.

Taste Changes

Dysgeusia is one of the adverse reactions listed in the original Tepezza label.

This condition causes a change in taste perception, causing food or drinks to taste different than usual.

Some people may experience a metallic or bitter taste in their mouth, affecting their appetite and enjoyment of food.

In some cases, burning mouth syndrome, a condition characterized by a burning sensation, may also occur.

In the clinical trial, 8% of patients reported taste changes as a side effect.

However, this condition was mild for all patients and no one discontinued treatment.

Headache

Headache is another commonly reported side effect of Tepezza, which can range from mild to severe and may come with other symptoms such as nausea or fatigue.

In most cases, this side effect was manageable with over-the-counter pain medication.

8% of patients in the clinical trial experienced headaches.

However, all cases were mild, and none resulted in permanent treatment discontinuation.

Dry Skin

Tepezza can also cause dry skin as a side effect.

People may experience dryness, itchiness, flakiness, or red patches on their skin after Tepezza infusions.

Patients can manage this condition with appropriate skincare routines and creams recommended by a doctor.

In the clinical trial, 8% of patients reported dry skin as a side effect.

However, this condition was mild and manageable.

Weight Loss

Weight loss can also occur as a side effect of Tepezza treatment.

The medication can cause a decrease in appetite, leading to weight loss.

In the clinical trial, 6% of patients experienced weight loss while receiving Tepezza infusions.

However, this side effect did not cause patients to discontinue treatment.

Nail Disorder

Nail disorders, such as brittle nails or nail deformities, can also occur as a side effect of Tepezza treatment.

5% of patients in the clinical trial observed changes in their nails, such as broken nails and color changes.

However, these effects were not painful or bothersome.

Change in Menstruation

Women may experience changes in their menstrual cycle as a side effect of Tepezza.

In the clinical trial, 5 out of 22 menstruating patients experienced changes in their menstrual cycle during treatment with Tepezza.

These women reported spotting, cramps, menstrual pain, and missing periods.

However, most returned to their regular cycle after completing treatment.

Infusion Reaction

In some cases, patients may experience infusion reactions during or after receiving Tepezza infusions.

These reactions can include:

• High Blood Pressure
• Fast Heartbeat
• Redness of the Face
• Feeling Hot
• Difficulty Breathing
• Headache
• Muscle Pain

Some patients may also experience allergic reactions, such as flushing, itchiness, and skin rash, either from the medication or the intravenous infusion.

Exacerbated Inflammatory Bowel Disease (IBD)

Tepezza can exacerbate pre-existing inflammatory bowel diseases (IBD) such as Crohn’s disease and ulcerative colitis.

In the clinical trial, one patient with a history of IBD experienced a flare-up during treatment.

Possible Effects on Pregnancy

Tepezza can potentially harm a developing fetus and should not be used during pregnancy.

Female patients who are pregnant or plan to become pregnant must discuss treatment options with their doctor before starting Tepezza.

Additionally, women of reproductive age must use effective birth control before the first dose, during treatment, and for at least six months after the last Tepezza infusion.

Tepezza and Hearing Loss

In the clinical trials, 10% of patients experienced hearing loss as a side effect.

They reported hearing problems, such as: 

• Deafness
• One or both ears obstructed with fluid
• Issues in loudness perception
• Impairment in hearing certain sounds

However, it’s crucial to note that the clinical trials took place before the FDA’s approval.

In 2021, the Endocrine Society published a study on the link between hearing loss and Tepezza treatment.

They found that 65% of patients had hearing problems after an average of 3.6 Tepezza infusions.

The most common symptoms included:

• Subjective Hearing Loss: Patients feel like their hearing has decreased but cannot notice any significant changes in loudness.
• Tinnitus: Patients hear a ringing, buzzing, or humming sound in their ears.
• Ear Plugging Sensation: Patients feel like they have cotton or fluid in their ears.
• Autophony: Patients hear their own voice or breathing too loudly.

Additionally, four of the Endocrine Society study’s patients experienced new or worsened sensorineural hearing loss, a permanent type of hearing loss caused by nerve damage in the inner ear.

Three patients had a patulous eustachian tube, a condition where the eustachian tube stays open, causing ear fullness or autophony.

Growing Concerns on Tepezza and Hearing Loss

The increasing number of patients experiencing hearing loss during Tepezza treatment has raised concerns among the medical community.

As Tepezza infusions can potentially result in permanent hearing impairment, more research is necessary to understand the medication’s impact on hearing and its possible long-term effects.

The FDA updated Tepezza’s prescribing information in 2023 to include a warning about potential hearing loss as a side effect. In some cases, permanent hearing loss may occur after Tepezza infusions.

The FDA urges healthcare providers to assess their patients’ hearing before and during treatment with Tepezza and monitor for any changes in hearing after completing treatment.

Patients must disclose any pre-existing medical conditions and use of prescription drugs and dietary and herbal supplements to their doctor before starting Tepezza treatment.

As of December 31, 2023, the FDA received the following reports:

• 199 cases of tinnitus
• 118 cases of deafness
• 67 cases of ear discomfort
• 56 cases of permanent deafness
• 24 cases of ear pain
• 20 cases of auditory disorder
• 18 cases of neurosensory deafness

Unfortunately, more and more victims of hearing loss due to Tepezza treatment are coming forward, leading to lawsuits against responsible parties.

Tepezza Hearing Loss Lawsuits

Tepezza hearing loss lawsuits fall under product liability, where manufacturers can be held responsible for the harm caused by their products.

In Tepezza Lawsuits, victims seek compensation for medical expenses, lost wages, pain and suffering, and other related damages.

The allegations in the Tepezza hearing loss lawsuits against the manufacturer, Horizon Therapeutics, include:

• Inadequate Safety Testing: The manufacturer failed to conduct sufficient and thorough clinical trials on Tepezza before its release, leading to unexpected side effects such as hearing loss.
• Failure To Warn: The manufacturer failed to warn patients and healthcare providers of the risks associated with Tepezza treatment, including potential hearing loss.
• Not Updating the Product Label: The manufacturer failed to update Tepezza’s prescribing information with a warning about potential hearing loss, even though they were aware of the risks.

Tepezza hearing loss claims filed against Horizon Therapeutics are ongoing, and more individuals may join the lawsuits as they continue to experience hearing loss related to Tepezza treatment.

Potential Damages and Implications of Tepezza Lawsuits

In civil lawsuits filed against drug manufacturers for dangerous medications, individuals seek compensation in the form of damages.

Damages cover all losses related to the dangerous medication.

Patients and their families may receive compensation for their losses, including:

• Medical expenses related to hearing loss treatment
• Loss of income due to inability to work or loss of a job
• Pain and suffering caused by hearing impairment

Current Status of Legal Proceedings

Tepezza Hearing Loss Lawsuits are ongoing.

The U.S. Judicial Panel on Multidistrict Litigation (JPML) established an MDL (multidistrict litigation) in the U.S. District Court for the Northern District of Illinois for all Tepezza Lawsuits.

Judge Thomas Durkin is currently presiding over the litigation process.

This consolidation of cases aims to streamline the pre-trial proceedings and efficiently handle multiple similar lawsuits.

Seeking Legal Action for Tepezza Hearing Problems

Victims who received Tepezza treatment and developed permanent hearing impairment may be eligible to seek legal action against the responsible parties.

It’s essential to consult a qualified attorney specializing in dangerous drug cases for a thorough review of your case.

Expert lawyers are crucial in representing individuals affected by Tepezza’s side effects.

Some of the benefits of hiring an experienced Tepezza Lawyer include:

• Access to relevant resources and information to build a strong case
• A proper understanding of the legal process and legal expertise to navigate it efficiently
• Negotiation skills to seek fair compensation for victims’ losses
• A dedicated and compassionate approach to representing the victims’ best interests

Tepezza lawyers can guide victims through the legal process, provide support and guidance, and fight for their rights to seek justice and compensation for the harm caused by Tepezza treatment.

TorHoerman Law: Your Tepezza Lawyers

TED is already a debilitating disease that significantly impacts one’s quality of life.

However, experiencing permanent hearing loss as a side effect of Tepezza treatment can make matters even worse.

If you or a loved one have experienced hearing loss after receiving Tepezza treatment, you may be eligible for compensation.

At TorHoerman Law, we understand the devastation of unexpected side effects from medications like Tepezza.

Our team of experienced lawyers is dedicated to helping victims seek justice and compensation for their losses.

Contact us for a free consultation.

You can also use the chatbot on this page to find out if you qualify for the Tepezza Lawsuit instantly.