Tepezza Side Effects

Tepezza Side Effects

Understanding the Risks and Legal Options

Tepezza (teprotumumab-trbw), a groundbreaking treatment for thyroid eye disease (TED), has offered relief to many patients suffering from this rare autoimmune disorder. However, recent concerns have emerged about Tepezza side effects, particularly its potential link to hearing loss and other otologic symptoms. For patients who have experienced auditory complications, including hearing loss, tinnitus, ear plugging, and autophony, the impact on daily life can be significant. Understanding these risks and consulting a Tepezza lawsuit lawyer to know your legal rights is essential.

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What is Tepezza?

Tepezza is the first and only FDA-approved medication specifically designed to treat thyroid eye disease. Developed by Horizon Therapeutics, it received FDA approval in January 2020, marking a significant milestone in the treatment of this rare autoimmune disorder.

Thyroid eye disease causes inflammation and swelling of the tissues surrounding the eyes, leading to a range of uncomfortable and often distressing symptoms. These can include eye bulging (proptosis), double vision (diplopia), eye pain, and, in severe cases, vision loss.

Tepezza works by targeting and blocking the activity of the insulin-like growth factor 1 receptor (IGF-1R), a protein believed to play a crucial role in the development and progression of TED. By inhibiting IGF-1R, Tepezza aims to reduce the inflammation and tissue changes associated with the disease.

The medication is administered intravenously (IV) over three to six months, with patients typically receiving eight infusions in total. Clinical studies have shown promising results, with many patients experiencing significant improvements in their symptoms.

According to an FDA news release, the FDA granted the application Priority Review, in addition to Fast Track and Breakthrough Therapy Designation. Tepezza also received Orphan Drug Designation, which provides incentives to drug companies to assist and encourage the development of drugs for rare diseases or conditions. 

Tepezza and Hearing-Related Side Effects

Recent research has uncovered a concerning link between Tepezza use and various hearing-related issues. These otologic symptoms include:

• Hearing loss (partial or complete)
• Tinnitus (ringing in the ears)
• Ear plugging sensation
• Autophony (perception of one's own voice as unusually loud or echoing)
• Eustachian tube dysfunction
• Hyperacusis (increased sensitivity to everyday sounds)

A study presented at the ENDO 2021 conference revealed that 65% of patients taking Tepezza reported otologic symptoms, a rate significantly higher than the 10% initially reported by Horizon Therapeutics in earlier clinical trials. These symptoms typically emerged after an average of 3.6 infusions.

Sensorineural Hearing Loss

Of particular concern is the development of sensorineural hearing loss in some patients. This type of hearing loss involves damage to the inner ear's hair cells or the auditory nerve pathways. Unlike some forms of hearing loss, sensorineural hearing loss is often permanent and can significantly impact a person's quality of life.

A case study published in The Annals of Otology, Rhinology, and Laryngology detailed a patient who experienced significant hearing loss after Tepezza treatments. Notably, the patient's symptoms persisted even after discontinuing the drug and receiving oral corticosteroid treatment.

Long-Term Impact on Hearing

The American Journal of Ophthalmology published findings on Tepezza's long-term impact on hearing function. The study showed that only a small portion of patients who experienced subjective hearing loss or decreased word comprehension fully recovered eight months after stopping Tepezza infusions. This suggests that for some patients, the hearing issues may be long-lasting or potentially permanent.

Impact on Patients: The Devastation of Hearing Loss

Living with hearing loss can be life-altering. Many patients rely on their auditory senses for work, social interactions, and maintaining a normal daily routine. For those who develop hearing issues after taking Tepezza, the effects can be devastating, leading to:

• Communication Difficulties: Hearing loss often impairs the ability to understand conversations, especially in noisy environments, affecting personal relationships and professional life.
• Emotional Distress: Sudden or gradual hearing loss can lead to feelings of isolation, frustration, and depression, as individuals struggle to adapt to the changes in their sensory abilities.
• Financial Burden: Hearing aids, medical treatments, and specialized care for hearing loss can be expensive, often placing a significant financial strain on individuals and families.

When patients are not adequately warned about these risks, the emotional and financial toll can be compounded, leaving individuals feeling uncertain about their next steps.

Mechanism of Tepezza-Induced Hearing Loss

While the exact mechanism by which Tepezza may cause hearing damage is not fully understood, researchers have proposed some theories. A case series documented in medical literature suggested a potential link between Tepezza's inhibition of IGF-1R and damage to the inner ear structures.

The IGF-1 signaling pathway plays a crucial role in the development and maintenance of the inner ear. By blocking this pathway, Tepezza may inadvertently interfere with the normal functioning and repair processes of the auditory system. This could explain why some patients experience hearing loss or other auditory problems during or after treatment.

Tepezza Litigation and Legal Options

In light of the emerging evidence linking Tepezza to serious hearing-related side effects, many patients have begun to explore legal options. In 2022, a wave of product liability lawsuits were filed against Horizon Therapeutics by individuals who experienced hearing loss or tinnitus following Tepezza treatments.

These legal actions allege that Horizon failed to adequately warn patients and healthcare providers about the significant risks of hearing damage associated with the medication. Plaintiffs claim that the absence of sufficient warning about potential hearing complications left them and their doctors unaware of the drug's possible harmful effects.

Multidistrict Litigation (MDL)

Recognizing the growing number of similar cases, the federal court system took action in June 2023. Tepezza hearing loss lawsuits from various federal courts nationwide were consolidated into a multidistrict litigation (MDL) under the supervision of Judge Thomas M. Durkin in the U.S. District Court for the Northern District of Illinois.

As of the latest reports, over 170 lawsuits are pending within this MDL. The legal process is set to continue, with the first Tepezza bellwether trials scheduled for 2026. These initial trials will likely play a crucial role in shaping the trajectory of the ongoing litigation and potential settlements.

What to Do If You've Experienced Hearing Loss After Using Tepezza

If you've undergone Tepezza treatment and are experiencing hearing loss or other auditory problems, it's crucial to take prompt action to protect both your health and your legal rights. Here are some important steps to consider:

• Seek immediate medical attention: Consult an audiologist or an ear, nose, and throat (ENT) specialist for a comprehensive evaluation of your hearing.
• Document your symptoms: Keep a detailed record of when you started noticing hearing problems and how they've progressed. Include any impact on your daily life, work, or relationships.
• Gather medical records: Collect all records related to your Tepezza treatment and subsequent hearing issues. This includes prescription information, treatment dates, and any relevant test results.
• Report the side effect: Inform your prescribing doctor about your hearing problems. They should report this to the FDA's MedWatch program.
• Don't stop treatment without medical advice: While it's natural to be concerned, never discontinue any medication without consulting your healthcare provider first.
• Consult a legal professional: Given the ongoing litigation surrounding Tepezza, speaking with an attorney experienced in pharmaceutical litigation is advisable. They can evaluate your case and advise you on potential legal options.

Legal Options for Tepezza Patients

If you've experienced hearing loss or other serious side effects after using Tepezza, you may be eligible to seek compensation through a Tepezza lawsuit. Potential damages in a Tepezza lawsuit could include:

• Medical expenses: Costs related to diagnosing and treating your hearing loss or other side effects.
• Lost wages or income: Compensation for time missed from work due to your injuries.
• Pain and suffering: Damages for physical pain and emotional distress caused by your injuries.
• Loss of quality of life: Compensation for how your injuries have impacted your daily life and activities.
• Future medical care: Costs of ongoing treatment or care you may need due to your injuries.

An experienced attorney from the Lawsuits.com network can help you understand your legal rights, gather necessary evidence, and navigate the complex process of filing a pharmaceutical lawsuit.

The Importance of Legal Representation

Managing a pharmaceutical lawsuit can be challenging, especially when dealing with large drug manufacturers and their legal teams. An experienced attorney can provide invaluable assistance in several ways:

• Case evaluation: Determine if you have grounds for a legal claim based on your specific circumstances.
• Evidence gathering: Collect and organize medical records, expert testimonies, and other crucial documentation to support your case.
• Legal strategy: Develop a comprehensive legal strategy tailored to your unique situation.
• Negotiations: Handle communications with drug manufacturers and insurance companies, working to secure a fair settlement on your behalf.
• Court representation: If necessary, present your case before a judge and jury.
• Staying informed: Keep you updated on the progress of the Tepezza multidistrict litigation and how it may affect your case.

Protecting Your Rights After Tepezza-Related Hearing Loss

While Tepezza has offered hope to many individuals suffering from thyroid eye disease, the reports of hearing loss and other auditory issues underscore the importance of comprehensive drug testing and transparent communication of potential risks. As the litigation surrounding Tepezza continues to unfold, it's crucial for patients who have experienced side effects to understand their rights and options.

If you or a loved one has experienced hearing problems after using Tepezza, don't hesitate to seek both medical and legal advice. An experienced attorney like those in the Lawsuits.com network of product liability lawyers can help you navigate this challenging situation and fight for the compensation you deserve. By taking action, you're not only advocating for your own rights but also contributing to the broader effort to ensure safer medications for all patients in the future.

Remember, every case is unique, and the steps you take should be tailored to your specific situation. A qualified medical professional can guide your health decisions, while an experienced attorney can help you understand and protect your legal rights. Don't let the complexities of pharmaceutical litigation deter you from seeking justice—reach out to a qualified attorney from the Lawsuits.com network today at (888) 984-6195 or through the online form for a free consultation to discuss your case and explore your legal options.