In recent years, Tepezza, a groundbreaking treatment for Thyroid Eye Disease (TED), has offered hope to many patients suffering from this debilitating condition. However, as its usage has increased, so too have reports of severe side effects, particularly those affecting hearing. These adverse effects have led to a surge in Tepezza lawsuits aimed at the drug’s manufacturer, Horizon Therapeutics.
If you or someone you love relies on Tepezza for treatment of TED, it is important to be aware of the serious side effects many patients are experiencing. Below, the harmful drug lawyers at Kherkher Garcia provide vital information about the growing number of Tepezza lawsuits. By understanding the basis of these lawsuits, patients and their families can better navigate the complexities of seeking justice and compensation for the harm they have experienced.
Tepezza: A Groundbreaking Treatment for Thyroid Eye Disease
Tepezza, the brand name for teprotumumab, is a prescription medication recently developed and approved for treating Thyroid Eye Disease (TED) and Graves’ eye disease. TED is characterized by chronic inflammation in the fatty tissue behind the eyes and other eye structures, resulting from an abnormal autoimmune response where the body’s immune system mistakenly targets the eye tissue. This inflammation causes the eyes to swell, significantly impairing vision. TED is often linked with hyperthyroidism and is primarily caused by Graves’ disease, an autoimmune disorder affecting the thyroid gland.
Tepezza is the first approved drug for treating Thyroid Eye Disease. It functions by blocking a specific protein believed to trigger the immune reaction leading to TED. Tepezza is administered via injection approximately every three weeks for about five months.
Horizon Therapeutics, a biopharma company specializing in rare rheumatoid and autoimmune diseases, developed Tepezza. The Food and Drug Administration (FDA) approved Tepezza in January 2020, and it remains under patent protection. However, like many new drugs on the market, FDA approval for Tepezza was based on limited testing without fully understanding its exact mechanism of action. The clinical trial used for Tepezza’s FDA approval included fewer than 100 patients.
What are the Symptoms of Thyroid Eye Disease?
Thyroid Eye Disease (TED), also known as Graves’ orbitopathy or Graves’ ophthalmopathy, presents with various symptoms that can vary in severity. The common symptoms include:
- Eye Bulging (Proptosis): Prominent or protruding eyes.
- Eye Pain: Discomfort or pain in or around the eyes.
- Dry Eyes: Insufficient tear production leading to dryness.
- Redness and Swelling: Inflammation causing red and swollen eyes or eyelids.
- Double Vision (Diplopia): Seeing two images of a single object.
- Light Sensitivity (Photophobia): Discomfort or pain when exposed to light.
- Blurry Vision: Reduced clarity of vision.
- Pressure or Pain Behind the Eyes: Sensation of pressure or pain behind the eyeball.
- Restricted Eye Movement: Difficulty moving the eyes in certain directions.
- Lid Retraction: Upper eyelids pulling back, exposing more of the eye.
If you experience any of these symptoms, it’s crucial to seek medical advice, as early intervention can help manage the condition more effectively.
How Does Tepezza Work?
Tepezza works by targeting and inhibiting a specific protein called insulin-like growth factor-1 receptor (IGF-1R). This receptor is believed to play a key role in the autoimmune response that causes Thyroid Eye Disease (TED). Here’s how Tepezza functions:
- Blocking IGF-1R: Tepezza is a monoclonal antibody that binds to the IGF-1R on the surface of cells.
- Inhibiting Immune Response: By binding to IGF-1R, Tepezza prevents the receptor from being activated by its natural ligand, insulin-like growth factor-1 (IGF-1). This inhibition reduces the abnormal immune response that targets the eye tissues.
- Reducing Inflammation: The inhibition of IGF-1R helps to decrease the inflammatory response in the tissues behind the eyes, thereby reducing swelling and inflammation.
- Improving Symptoms: By mitigating the inflammatory process, Tepezza helps alleviate the symptoms of TED, such as eye bulging, redness, pain, and double vision.
What Side Effects are Associated with Tepezza?
Tepezza, like many medications, can cause side effects. Common side effects associated with Tepezza include:
- Muscle Spasms: Involuntary muscle contractions.
- Nausea: Feeling of sickness or discomfort in the stomach.
- Hair Loss (Alopecia): Thinning or loss of hair.
- Diarrhea: Loose or watery stools.
- Fatigue: General feeling of tiredness or lack of energy.
- High Blood Sugar (Hyperglycemia): Elevated levels of glucose in the blood.
- Hearing Impairment: Issues with hearing, such as reduced ability to hear or ringing in the ears (tinnitus).
- Dry Skin: Skin becoming dry or flaky.
- Altered Taste (Dysgeusia): Changes in the sense of taste.
Less common but more serious side effects can include:
- Infusion Reactions: Reactions occurring during or shortly after the infusion, such as chills, fever, shortness of breath, or flushing.
- Inflammation of the Pancreas (Pancreatitis): Severe pain in the abdomen, nausea, and vomiting.
- Increased Risk of Infections: Due to changes in the immune response.
Patients receiving Tepezza should be monitored by their healthcare provider for any side effects, especially those that are severe or persistent. If any serious side effects occur, seek medical attention immediately.
Tepezza Hearing Loss
According to a study reported by the Endocrine Society, as many as 65 percent of patients receiving Tepezza infusions experienced hearing side effects. These side effects typically emerged after an average of 3.6 infusions and included:
- Subjective hearing loss
- Tinnitus (ringing in the ears)
- An ear-plugging sensation
- Autophony (the perception that one’s own voice is unusually loud)
Some patients experienced a combination of these symptoms. The underlying damage to the inner ear labyrinth that leads to these symptoms includes:
- Sensorineural hearing loss: hearing loss caused by damaged hair cells in the inner ear
- Patulous Eustachian tube: the Eustachian tube stays open, resulting in autophony
As of December 31, 2022, the FDA had received reports of the following hearing-related adverse effects:
- 117 cases of hearing loss
- 84 cases of tinnitus
- 68 cases of deafness
Tepezza Hearing Loss Lawsuit Information
Tepezza has been linked to significant hearing-related side effects in many patients. As a result, a growing number of lawsuits have been filed against Horizon Therapeutics. These lawsuits generally focus on the following key points:
- Hearing Loss and Other Adverse Effects: Patients report experiencing various hearing issues, including subjective hearing loss, tinnitus (ringing in the ears), ear-plugging sensations, and autophony (the perception of one’s own voice being unusually loud). Some cases have progressed to more severe outcomes like sensorineural hearing loss and deafness.
- Lack of Adequate Warnings: Plaintiffs allege that Horizon Therapeutics failed to provide sufficient warnings about the potential risks of hearing loss associated with Tepezza. They argue that the company did not adequately inform patients and healthcare providers about these serious side effects.
- Negligence and Liability: The lawsuits claim that Horizon Therapeutics was negligent in its duty to ensure the safety of Tepezza. This includes accusations of inadequate testing and insufficient disclosure of potential risks before the drug was marketed and prescribed.
- Seeking Compensation: Affected patients are seeking compensation for medical expenses, pain and suffering, lost wages, and other damages resulting from the adverse effects of Tepezza. These lawsuits aim to hold Horizon Therapeutics accountable for the harm caused by their product.
As more patients come forward with similar complaints, the number of Tepezza hearing loss lawsuits is expected to rise, potentially leading to significant legal and financial repercussions for Horizon Therapeutics.
Should I Contact a Lawyer after Tepezza Hearing Loss?
If you have experienced hearing loss or other adverse effects after using Tepezza, contacting a lawyer is a prudent step. Here are some reasons why seeking legal advice might be beneficial:
- Understanding Your Rights: A lawyer can help you understand your legal rights and whether you have a valid claim against the manufacturer.
- Evaluating Your Case: An experienced lawyer can evaluate the specifics of your case, including the extent of your injuries and the potential for compensation.
- Navigating the Legal Process: Filing a lawsuit involves complex legal procedures. A lawyer can guide you through this process, ensuring all necessary documents are filed correctly and deadlines are met.
- Gathering Evidence: A lawyer can assist in gathering and preserving evidence to support your claim, such as medical records, expert testimonies, and documentation of your symptoms and treatment.
- Maximizing Compensation: An lawyer can help you pursue the maximum compensation for your injuries, covering medical expenses, lost wages, pain and suffering, and other damages.
- Holding the Manufacturer Accountable: Legal action can hold Horizon Therapeutics accountable for any negligence or failure to warn about the risks associated with Tepezza.
Given the potential complexities of cases involving pharmaceuticals, consulting with a lawyer who specializes in cases involving these products can provide you with the best chance of achieving a favorable outcome.
Contact Kherkher Garcia About Tepezza Lawsuits
Have you or a loved one experienced hearing loss or other severe side effects after using Tepezza? You may be entitled to compensation for your injuries. At Kherkher Garcia, we specialize in personal injury, including harmful drugs. We are committed to holding negligent pharmaceutical companies accountable.
Why Choose Kherkher Garcia?
- Expertise: Our experienced legal team understands the complexities of Tepezza lawsuits.
- Personalized Attention: We provide dedicated, one-on-one support to ensure your case gets the attention it deserves.
- No Fees Unless We Win: We operate on a contingency fee basis, so you pay nothing unless we secure a settlement or verdict for you.
Contact us now for a free, no-obligation consultation to discuss your case and explore your legal options. Let Kherkher Garcia fight for the justice and compensation you deserve. Call us at 713-333-1030 or submit our online contact form to get started.
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