Warning Alert: Prescription Medication Tepezza Side Effects

Tepezza is a medicine that helps reduce bulging eyes caused by Thyroid Eye Disease, also known as Graves disease. Tepezza can’t cure thyroid eye disease or bulging eyes, but it can help relieve certain symptoms for some patients. We are filing Tepezza Lawsuits now.

Recent concerns have arisen regarding potential adverse side effects associated with Tepezza usage. One significant side effect is the potential for loss of hearing and deafness.

At The Yost Legal Group, our dangerous drug lawyers think it’s important to address these concerns. The pharmaceutical company, Horizon Therapeutics, did not properly warn Tepezza users about the potentially dangerous side effects.

If you are using Tepezza for thyroid eye disease treatment and have lost your hearing, contact The Yost Legal Group at 800-967-8529.

Please be mindful of potential risks with Tepezza. Our team of defective drug lawyers at The Yost Legal Group is here to provide assistance and guidance every step of the way.

What is Tepezza?

Tepezza is an infusion medication that was approved by the United States Food and Drug Administration (FDA) in 2020 to treat the symptoms of thyroid eye disease (TED). Manufactured and distributed by Horizon Therapeutics (Horizon), Tepezza is the first medication approved by the FDA to treat the symptoms of TED. It is administered intravenously as a series of eight infusions over the course of several months.

What Is Thyroid Eye Disease?

Also known as Graves’ ophthalmopathy, thyroid eye disease (TED) is a rare autoimmune disorder that causes inflammation, redness, and swelling to the tissues and muscles of the eye. It affects approximately 16 of every 100,000 women and 2.9 of every 100,000 men.

Symptoms of thyroid eye disease include:

• Blank stare
• Bulging of the eyes
• Double vision
• Inability to close eyelids
• Pain behind the eyes
• Pain with eye movement
• Red eyes
• Watery eyes

Details About Tepezza

Tepezza is a biologic drug that belongs to a group of drugs known as insulin-like growth factor-1 receptor inhibitors (IGF-1R). It contains the active drug teprotumumab. In form, Tepezza is a powdery substance stored in vials in 500-milligram doses.

Healthcare professionals mix the powdered drug with a liquid solution before administering it to patients via an intravenous (IV) infusion.

It is important for The Yost Legal Group to note that Tepezza does not cure thyroid eye disease. However, it has been proven to help relieve certain symptoms of TED in some cases.

The issues, however, lie in the adverse side effects that Tepezza use has been linked to and in the fact that the manufacturer, Horizon Therapeutics, failed to warn potential Tepezza users of those adverse side effects.

Most notably, Tepezza has been linked to hearing loss as an adverse side effect. You can file a hearing loss lawsuit against the drug manufacturer. Our defective drug attorneys are highly experienced in these types of liability cases. We always offer a free case evaluation.

Permanent Hearing Damage from Tepezza

While found to be an effective therapeutic for TED, Tepezza has been linked to permanent hearing loss and total deafness.

In fact, as soon as the medication became available on the market, numerous patients who received Tepezza infusions began reporting issues with tinnitus (ringing in the ears), reduced or muffled hearing, as well as permanent hearing loss, and total deafness.

After years of receiving reports about adverse side effects after using Tepezza, the FDA finally added a hearing loss and impairment warning to the Tepezza label in July 2023.

You may find the FDA’s drug facts and a warning label for Tepezza here.

Take Tepezza Side Effects Seriously

• Permanent hearing loss: Muffled or reduced hearing over time.
• Total deafness: Inability to hear speech, but some sound perception might remain.

If you or a loved one has suffered from permanent hearing loss or total deafness after using Tepezza, The Yost Legal Group is here to help. Contact our defective pharmaceutical lawyers for a free consultation. Contact us today. We are available by e-mail, phone, and text.

When Did Horizon Therapeutics Know About the Risks of Tepezza?

Limited Clinical Trials

The initial (and only) clinical trial Horizon used to receive FDA approval for Tepezza contained fewer than 100 patients using the medication. Of that small initial trial, about 10 % of participants reported experiencing some sort of hearing damage.

Despite this early indication, the warning label failed to adequately address hearing loss and the permanency of this condition as an adverse reaction from Tepezza use.

Additional Research Done on Tepezza

After the medication was approved and hit the market, reports began circulating that more and more patients were experiencing hearing damage and tinnitus as a result of the Tepezza infusions.

In fact, a 2021 study published by the Endocrine Society indicated that approximately 65% of patients receiving Tepezza infusions developed hearing damage after approximately three infusions. That is more than three times the percentage of what was previously reported by Horizon from their clinical trial.

Additional reliable research continues to establish the link between Tepezza infusions and otologic issues.

Horizon notified the FDA on numerous occasions between 2020 and 2022 of patient’s adverse reactions to Tepezza. However, despite knowledge of these risks, Horizon failed to proactively upgrade the label to sufficiently warn of the risk of hearing damage from the use of its drug.

 

Lawsuits Against Horizon for Failure to Warn About Adverse Drug Reactions

The lawsuits against Horizon allege that Horizon failed to adequately warn of the risk of permanent hearing damage from the use of its drug Tepezza, based upon pre-market and post-market research that indicated the strong association between Tepezza and hearing impairment.

Plaintiffs also allege the following:

Horizon failed to warn treating doctors of the need to closely monitor their patients’ hearing throughout the series of infusions.

Horizon failed to perform sufficient testing on the medication prior to FDA approval.

Horizon misrepresented the scope of individuals who would benefit from the use of the medication as widespread when, in fact, the number of individuals with TED is quite small.

A New Multi-District Tepezza Litigation

In June of 2023, all Tepezza lawsuits were consolidated into a multi-district litigation (MDL) in the Northern District of Illinois to be overseen by the Honorable Judge Thomas M. Durkin. By consolidating all pending Tepezza lawsuits and future cases into one court, it relieves the burden on state and federal courts across the country from managing numerous cases with similar facts.

While the cases are similar in facts and injury, each case is examined individually, and compensation is specific to, among other factors, the severity of each plaintiff’s impairment. This allows for efficiency and, upon settlement, fairness for those severely impaired or wronged.

The MDL for this litigation is quite new, with policies and procedures still being determined among the parties. There are approximately 46 cases filed in the MDL right now. We anticipate that this MDL will remain highly specialized, with the total number of cases in this MDL reflective of a small number. This small number will include individuals, nationally and globally, who suffer from TED and subsequently underwent treatment with Tepezza infusions.

Contact Compassionate Tepezza Lawyers at The Yost Legal Group for Immediate Assistance

The Tepezza lawyers at The Yost Legal Group have decades of experience in pursuing defective drug claims against manufacturers of dangerous and defective drugs. The Yost Legal Group is pursuing Tepezza cases nationwide for individuals who suffered permanent hearing loss or total deafness as a result of receiving Tepezza infusions for the treatment of TED.

Let The Yost Legal Group File Your Tepezza Claim

If you or a loved one has experienced adverse side effects such as permanent hearing loss or total deafness after receiving Tepezza infusions, contact the experienced Tepezza lawyers at The Yost Legal Group today. There is no time to delay.

The Yost Legal Group operates on a “no win/no fee” basis–you pay no fee or expense unless you receive a recovery by decision or settlement. All initial consultations are free.

Our experienced defective drug attorneys are available by e-mail, phone (1-800-YOST-LAW), and text (410-973-6686). Contact us today for a free initial consultation about your Tepezza claim.