The US FDA has issued a warning against Horizon Therapeutics’ Tepezza, as it has been found to cause hearing impairment, including hearing loss. This therapy is commonly recommended for thyroid eye disease; however, the new labeling suggests that the hearing loss resulting from it can be permanent.
The labeling also recommends that individuals should have their hearing tested before, after, and even during the use of Tepezza.
Currently, Horizon Therapeutics is facing several product liability lawsuits from former users who are experiencing irreversible hearing issues. These users claim if the drug maker alerted them their suffering could have been avoided.
In this article, we will discuss how Tepezza has caused hearing issues in people and how victims can file legal complaints.
Tepezza Resulted in Tinnitus
In November 2022, Drugwatch reported on Horizon addressing the side effects of Tepezza in a press release. It mentioned that out of approximately 1000 patients who underwent a 19-month analysis, nearly 10% experienced hearing issues. During the clinical trials, adverse events were found to be manageable, but a few participants discontinued the therapy or experienced interruptions.
Horizon stated that, for most people, the hearing loss has been reversible and mild. But, a study published in February 2022 in the “American Journal of Ophthalmology” cited 81.5% of participants experiencing hearing issues.
According to a BMJ Case Reports study in April 2022, a woman suffered from tinnitus after receiving the third dose of Tepezza. Subsequently, she faced hearing loss after taking the fifth dose. Despite discontinuing all treatment, her symptoms did not improve after six weeks.
Understanding Tepezza: How Can People Be Careful?
Tepezza is a new-age treatment that came to use in January 2020. It got used to treating double vision and bulging eyes due to thyroid eye disease. The conditions occur because of hyperthyroidism. It is also associated with Grave’s disease, leading to inflammation of tear glands, eyelids, and eye muscles. It also inflames the fatty tissue present behind the eyes.
Any standard Tepezza lawsuit claims that hearing loss occurs due to the blocking of IGF-IR. It is a protein that, after getting blocked, can affect the hair cells accountable for balance and hearing. The inner ear contains specialized hair cells that perceive sound waves and relay them to the human brain. Hence, damaged hair cells cause hearing loss and auditory problems.
Often, users face certain side effects from using Tepezza, which include:
- Muscle pain
- Increased blood pressure
- Headache
- Fast heartbeat
- Issues with breathing
- Redness in the face
If any person faces any or a combination of these issues, they need to get careful about it. Ideally, they should immediately stop using it and get a medical consultation. If the medical examination proves Tepezza to be the cause of these side effects, they can think about taking legal action.
Filing a Legal Complaint Against Tepezza
If anyone you know has suffered after using Tepezza, they can file a lawsuit. The individual must receive at least a single dose of the drug. People who face hearing loss, tinnitus, and other complications are also eligible for filing a lawsuit. The settlement amount can vary between $140,000 to $250,000 and is case specific.
Using Tepezza isn’t sufficient for qualifying for a product liability case or mass tort lawsuit. There needs to be medical evidence of hearing issues that you didn’t have before using this drug.
Victims can claim compensation to cover non-economic and economic losses in a mass tort case. The non-economic losses include:
- Any inconvenience that occurred due to the drug use
- Loss of the overall life quality
- Suffering and pain
- Emotional distress
The economic losses include costs linked to the injury:
- Lost wages
- Any out-of-pocket costs
- Medical devices, like medical treatment, surgery, and prescriptions
- The daily assistance costs, such as transportation and household work
- Losing the earning capacity
TruLaw suggests that you need to adhere to state laws while filing a legal complaint against Tepezza. According to the “statutes of limitation,” there is a 1 to 5-year time to file the complaint. It is necessary to initiate the lawsuit during this time to recover the damages. Once you secure medical evidence, connect with a lawyer to take legal action.
Managing Symptoms: Options for Those Affected by Tepezza
Paragraph: For those who have been affected by Tepezza’s side effects, particularly hearing loss and tinnitus, managing the symptoms becomes an immediate priority. Medical professionals may recommend various therapies such as hearing aids, tinnitus masking devices, or cognitive behavioral therapy to help individuals cope with these challenges.
Additionally, lifestyle changes, including avoiding loud noises and using protective ear equipment, may prevent further damage.
Consultation with specialists in audiology and ENT (Ear, Nose, and Throat) can lead to personalized treatment plans tailored to an individual’s unique situation.
Open communication with healthcare providers and a proactive approach to symptom management can empower patients to live more comfortably with these conditions, despite the challenges posed by Tepezza-induced hearing loss.
Tepezza and Regulatory Oversight: An Examination of FDA Approvals and Post-Marketing Surveillance
Paragraph: The relationship between Tepezza and hearing-related complications highlights the vital importance of regulatory oversight in pharmaceuticals. This case raises questions about the Food and Drug Administration’s (FDA) approval process and subsequent monitoring of drugs once they are on the market.
While Tepezza underwent clinical trials and met the regulatory standards for approval, the emergence of hearing loss as a significant side effect emphasizes the necessity for robust post-marketing surveillance.
Continuous monitoring, transparent reporting, and prompt action when adverse events are identified can help protect public health. Collaboration between regulatory bodies, healthcare providers, and pharmaceutical companies is essential to refine the processes of drug evaluation and safety monitoring.
In the case of Tepezza, a thorough examination of approval procedures and post-marketing actions can shed light on ways to prevent similar issues in the future.
Conclusion
The emerging link between Tepezza and hearing loss raises significant concerns for patients and healthcare providers. While most cases seem manageable, the growing number of reports indicating otherwise demands attention and action.
Victims with permanent hearing issues deserve both justice and compensation for the hazards they endure. Hence, regulatory bodies and drug manufacturers must prioritize patient safety. Comprehensive monitoring, improved warning labels, and transparent communication are essential steps toward preventing avoidable harm.
