Tepezza (teprotumumab) has gained attention as a groundbreaking treatment for Thyroid Eye Disease (TED), a rare autoimmune condition that causes inflammation and tissue expansion around the eyes. Approved by the U.S. Food and Drug Administration (FDA) in 2020, Tepezza has offered hope to thousands of patients experiencing the painful and debilitating symptoms of TED. However, recent studies and patient reports suggest that Tepezza may come with a serious side effect: Tepezza hearing loss.
If you or a loved one has experienced hearing complications after using Tepezza, it is crucial to understand the emerging evidence, potential legal options, and how you can protect your rights. Kherkher Garcia’s harmful drug attorneys are here to help you navigate this complex situation and seek justice.
What is Tepezza?
Tepezza is a monoclonal antibody designed to target and block the insulin-like growth factor-1 receptor (IGF-1R). By doing so, it reduces the inflammation and tissue overgrowth that contribute to the symptoms of TED. Administered through intravenous infusions, Tepezza has been praised for its ability to improve symptoms such as bulging eyes, double vision, and eye pain.
While Tepezza has transformed the lives of many TED patients, its potential risks have come under scrutiny. Hearing-related side effects have emerged as a growing concern, prompting further investigation by researchers and regulatory bodies.
What Does the Research Say?
Several studies have investigated the link between Tepezza and hearing loss, revealing troubling findings:
2021 Study in the Journal of the Endocrine Society
Researchers found that 65% of patients treated with Tepezza experienced hearing-related side effects. These included:
- Hearing loss
- Tinnitus (ringing in the ears)
- Autophony (increased perception of one’s voice)
- Ear pain or discomfort
Notably, the study emphasized that some patients continued to experience hearing issues even after discontinuing Tepezza, raising concerns about the potential for permanent damage.
2022 Study Presented at the American Thyroid Association Annual Meeting
This study highlighted that the risk of hearing loss appeared to increase with higher doses and longer treatment durations. Researchers recommended heightened monitoring of patients receiving Tepezza.
Patient Reports and Post-Market Surveillance
Since Tepezza’s approval, numerous patients have reported hearing problems to the FDA’s Adverse Event Reporting System (FAERS). These reports have bolstered the call for additional research and stronger warnings on the drug’s labeling.
How Does Tepezza Cause Hearing Loss?
The exact mechanism by which Tepezza affects hearing is not fully understood. However, scientists have proposed several theories:
- Impact on IGF-1R in the Ear: The insulin-like growth factor-1 receptor is present in the inner ear and plays a role in maintaining auditory function. Blocking this receptor may disrupt normal hearing processes.
- Inflammatory Response: Tepezza’s action on inflammation may inadvertently affect the delicate structures of the ear, leading to hearing impairment.
While further research is needed, the available evidence suggests a plausible link between Tepezza and hearing loss, making it essential for patients and healthcare providers to weigh the risks and benefits carefully.
Legal Implications: Who is Responsible?
Drug manufacturers have a legal duty to ensure the safety of their products and to provide adequate warnings about potential risks. In the case of Tepezza, the following legal issues may come into play:
- Failure to Warn: Patients may argue that Horizon Therapeutics, the manufacturer of Tepezza, failed to provide sufficient warnings about the risk of hearing loss. While the drug’s labeling includes some information about hearing-related side effects, critics assert that these warnings are inadequate given the severity and frequency of reported cases.
- Product Liability Claims: Individuals who have suffered hearing loss after using Tepezza may pursue product liability claims under theories such as:
- Defective Design: Arguing that Tepezza’s formulation is inherently unsafe.
- Manufacturing Defect: Alleging that errors during production contributed to the drug’s harmful effects.
- Negligence: Claiming that Horizon Therapeutics failed to conduct sufficient testing or acted recklessly in marketing the drug.
- Medical Monitoring Claims: Patients who have not yet experienced hearing loss but are at risk due to Tepezza exposure may seek compensation for ongoing medical monitoring to detect potential issues early.
Potential Compensation for Victims
Victims of Tepezza-related hearing loss may be entitled to various forms of compensation, including:
- Medical Expenses: Covering costs for audiological evaluations, hearing aids, or other treatments.
- Lost Wages: Addressing income lost due to hearing impairment or related medical appointments.
- Pain and Suffering: Compensating for the emotional and psychological toll of hearing loss.
- Punitive Damages: In cases of egregious misconduct by the manufacturer, courts may award punitive damages to deter similar behavior in the future.
What Should You Do If You’ve Experienced Hearing Loss from Tepezza?
If you suspect that Tepezza has caused hearing loss or other complications, it is essential to take the following steps:
- Seek Medical Attention: Consult a healthcare provider to evaluate your hearing and document any changes. Audiologists and otolaryngologists can provide specialized assessments and recommend appropriate treatments.
- Document Your Experience: Keep a detailed record of your Tepezza treatment, including infusion dates, dosages, and any side effects you’ve experienced. Save copies of medical records, prescriptions, and communication with healthcare providers.
- Report Adverse Effects: File a report with the FDA’s MedWatch program to help regulators track safety concerns and take action if necessary.
- Consult a Legal Professional: An experienced attorney can assess your case, explain your legal rights, and guide you through the process of seeking compensation. Acting quickly is important, as statutes of limitations may apply.
How Kherkher Garcia Can Help
At Kherkher Garcia, we are committed to holding pharmaceutical companies accountable for the harm their products cause. Our experienced attorneys understand the complexities of product liability cases and have a proven track record of success.
When you work with us, we will:
- Conduct a thorough investigation of your case, including reviewing medical records and consulting with experts.
- Build a strong legal strategy tailored to your circumstances.
- Handle all communication with the drug manufacturer and their legal team.
- Fight tirelessly to secure the compensation you deserve.
While Tepezza offers hope to many suffering from Thyroid Eye Disease, its potential to cause serious hearing loss cannot be ignored. Studies, patient reports, and expert analyses have raised red flags about the drug’s safety, prompting questions about Horizon Therapeutics’ responsibility to protect patients.
Get Answers to Your Tepezza Hearing Loss Questions
If you or a loved one has experienced hearing loss after using Tepezza, you are not alone. Get answers and learn more about your legal rights by contacting Kherkher Garcia. Our team of harmful drug attorneys is here to support you every step of the way, from understanding your legal options to pursuing justice.
Contact Kherkher Garcia today for a free consultation and take the first step toward reclaiming your life. Call 713-333-1030, or submit our online contact form today to get started.
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