CALL NOW Frequently asked questions about tepezza, permanent hearing loss, and lawsuits
Understanding Your Rights in a Tepezza Class Action Lawsuit
Nationwide, injured patients are moving forward with Tepezza lawsuits. If you’re considering filing a claim, you probably have some questions about the legal process and Tepezza injuries. Turn to a Tepezza class action attorney at Team Law for answers you can trust.
What Is Tepezza?
Tepezza is the trade name under which biopharmaceutical company Horizon Therapeutics sells the medication teprotumumab. This medication is administered in the form of a series of intravenous (IV) infusions given at outpatient infusion centers, hospitals, and doctors’ offices.
What Is Tepezza Used For?
Tepezza treats thyroid eye disease (TED) and its symptoms, including the following:
- Eye bulging
- Eye swelling
- Double vision
- Eye redness
- Eye pain
In this rare autoimmune disease, inflammation of the muscles and tissues behind the eye results in proptosis, or the bulging or protrusion of the eyes. People who suffer from this condition often (but not always) have Graves’ disease, which, among other effects, causes the body’s own immune system to attack the tissues surrounding the eyes. For that reason, TED may also be referred to as Graves’ ophthalmopathy or Graves’ eye disease.
For patients suffering from thyroid eye disease, the bulging and red appearance of the eyes is far from the only concern. The symptoms of TED can threaten a person’s vision and interfere with their daily activities, such as working and driving.
Tepezza’s 2020 approval by the U.S. Food and Drug Administration (FDA) made it the first drug treatment for thyroid eye disease. Until then, most of the limited treatment options for TED involved invasive surgeries, and it wasn’t unusual for patients with thyroid eye disease to need multiple surgical interventions.
How Does Tepezza Work?
Tepezza’s manufacturer, Horizon Therapeutics, claims that the medication works by treating thyroid eye disease at its source rather than merely managing symptoms.
The medication works by binding to and blocking the receptors located in the tissues behind the eye from being activated when the immune system attacks these tissues. With Tepezza blocking these receptors from being activated, existing symptoms of bulging, swelling, and redness can decrease in affected eyes, resulting in improvements in both vision and appearance.
How Long Does Tepezza Stay in Your System?
A full course of Tepezza consists of eight infusions given every three weeks over a period of five months. Infusion reactions can occur during the treatment or anytime during the following 24 hours.
However, this doesn’t mean Tepezza is already out of your system this quickly. In fact, with a half-life of 20 days, the drug can remain in your system for up to 100 days after the last dose is received.
In clinical trials, patients reported improvements in eye bulging in as little as six weeks after starting Tepezza treatment. Researchers behind a study published in the journal Drugs in 2022 reported that the clinical benefits of Tepezza treatment can last up to 51 weeks.
How Long Do Tepezza Side Effects Last?
Several side effects have been reported with Tepezza treatment. During and shortly after infusion treatments, common Tepezza side effects include:
- Fast heartbeat
- High blood pressure
- Muscle pain
- Headache
- Difficulty breathing
- Feeling hot
- Redness of the face
Tepezza may also cause side effects like the following:
- Worsening symptoms of inflammatory bowel disease (IBD)
- Increases in blood sugar
- Muscle spasms
- Nausea
- Diarrhea
- Hair loss
- Tiredness or fatigue
- Taste changes
- Dry skin
- Nail disorders
- Decrease in weight
Many of these side effects last only a short time, from a few days to a matter of weeks. Although it’s wise to see a doctor for any severe or concerning adverse events, many of these side effects are mild and go away on their own.
One particular side effect, hearing loss, has given rise to Tepezza lawsuits. While hearing loss is reversible in some patients, in others, it persisted months after stopping Tepezza treatment and is considered to be potentially permanent.
Is Tepezza Safe?
In approving Tepezza, the FDA weighed safety data from clinical trials and decided that the benefits sufficiently outweighed the risks of the drug, in general, to make the medication available on the market. However, both the clinical trials on the basis of which the drug was approved and post-marketing studies of the drug revealed the potential for adverse events.
In particular, patients with pre-existing inflammatory bowel disease and diabetes are warned that taking Tepezza could make IBD symptoms and blood sugar levels worse. Patients are also warned to discuss with their doctors the safety of taking Tepezza while pregnant or breastfeeding.
Tepezza’s label lists four warnings and precautions, including one that the FDA added in July 2023:
- Infusion reactions
- Exacerbation of inflammatory bowel disease
- Hyperglycemia (elevated blood glucose levels)
- Hearing impairment and hearing loss, which may be permanent
Whether Tepezza’s benefits outweigh the risks depends on individual factors, like a patient’s existing risk factors, the severity of their TED symptoms, and their level of comfort with risks such as hearing loss. However, it’s important for patients and their physicians to have full knowledge of the risks in order to make this determination. Tepezza lawsuits have alleged that the drug manufacturer knew (or should have known) about the risk of hearing loss but failed to warn physicians and patients.
Does Tepezza Cause Hearing Loss?
Hearing loss is an established potential side effect of Tepezza infusions.
Manufacturer Horizon Therapeutics asserted in a 2022 press release that only 10% of patients experienced “hearing-related events” and characterized such hearing loss as “mild to moderate and reversible.” Subsequent studies have sometimes reported very different findings. A small study cited in an article published in The American Journal of Managed Care put the percentage of patients who suffered hearing loss at a considerably higher 46%.
Following research linking Tepezza to hearing loss, the FDA added hearing impairment, including the potential of permanent hearing loss, to the drug’s warning label in July 2023. In its warning, the FDA advised prescribers to have hearing screenings performed before, during, and after treatment and to weigh the risk of potentially permanent hearing loss against the benefits of the treatment.
Is Hearing Loss From Tepezza Permanent?
In some patients, hearing loss from Tepezza can be temporary or reversible. Patients who experience this serious side effect may be prescribed oral or injectable corticosteroid treatments in addition to stopping further Tepezza treatments.
Unfortunately, hearing loss associated with Tepezza isn’t always reversible. Some patients have reported seeing improvements but not complete resolutions of their hearing problems, according to the article in The American Journal of Managed Care, while others reported no significant improvements even three months after stopping Tepezza. Patients whose hearing loss persists beyond a few months should contact a lawyer about potentially moving forward with a Tepezza Class Action Lawsuit.
What Tests and Treatments Can Screen for and Improve Hearing Loss From Tepezza?
Proactive screenings such as audiometric testing done before starting Tepezza infusions, as well as during and after treatment, are now recommended. Patients who have already undergone Tepezza treatment and suspect they may have suffered hearing loss may also benefit from these hearing tests, which can assess the extent of the patient’s hearing impairment.
Steroid treatments may be started in an attempt to reverse hearing loss, although these efforts haven’t always proven effective in treating hearing loss associated with Tepezza.
Even if you have suffered permanent hearing loss from taking Tepezza, you may be able to benefit from the use of medical devices like hearing aids and cochlear implants. These interventions can’t fix the underlying cause of your hearing loss but may be able to offer functional hearing improvements that can add value to your life.
What Is the Lawsuit Against Tepezza?
Patients who have sustained permanent hearing loss from Tepezza infusions are taking legal action. So many Tepezza lawsuits have been filed against Horizon Therapeutics that the dozens of individual claims already in progress have been consolidated into multidistrict litigation (MDL).
Through the Tepezza MDL, one federal judge will oversee the pre-trial discovery phase of litigation for all of the hearing loss lawsuits against Horizon Therapeutics, allowing evidence to be shared and resources pooled among all plaintiffs. For each individual claim, a Tepezza attorney will document the individual plaintiff’s unique damages and seek compensation that compensates them for their losses.
Contact a Knowledgeable Tepezza Lawyer at Team Law Today for a Free Case Review
Your ability to hear a favorite song or a loved one’s voice is priceless. Although no amount of money can ever fully make up for the loss of your hearing, getting the compensation you’re entitled to can make some hardships associated with hearing loss, like medical expenses and lost wages, easier to live with.
To start with a free consultation, contact a Tepezza lawyer at Team Law. We can evaluate your case and advise you on the next steps to pursue a Tepezza class action lawsuit.
