Childers, Schlueter & Smith has filed the first lawsuit in Georgia against the manufacturers of Tepezza, the first FDA-approved thyroid eye disease (TED) drug. The monoclonal antibody medication was heralded for its potential to relieve people suffering from the rare condition when it was released in 2020. But soon after its release to the public, troubling information came to light. Horizon Therapeutics USA, the biopharmaceutical company behind the medication, didn’t tell patients that the medicine might cause hearing damage. As a result, patients who took the drug to help with thyroid eye disease did not know they were at higher risk for auditory problems. A handful of Tepezza lawsuits have been filed in the last several months, and more will likely follow.
Tepezza can cause permanent hearing loss and tinnitus (ringing in the ears.) While the injectable drug was evaluated in double-masked, placebo-controlled studies, Horizon Therapeutics didn’t test the medication’s “mechanism of action.” The mechanism of action is how a drug affects the body. When Horizon submitted Tepezza to the FDA for approval, less than 100 patients had received the drug. Within months of the drug hitting the market, the agency began to receive reports of hearing loss and tinnitus after taking the medication.
What Is Thyroid Eye Disease?
Thyroid eye disease (TED), which is also known as Graves’ ophthalmopathy or thyroid-associated orbitopathy, is a rare autoimmune disease that only affects 19 in 100,000 people. The condition primarily affects people who have Graves’ disease, and sufferers often have eye pain, bulging eyes, swollen eyelids, and blurred vision. In some cases, the condition resolves independently, but some patients may need surgery for their symptoms to improve. Taking thyroid medication and quitting smoking can help control the disease, but TED patients may struggle with mood swings, irritability, and embarrassment about appearance changes.
What Is Tepezza?
Tepezza works by inhibiting the insulin-like growth factor 1 (IGF-1) receptor, which is suspected of playing a role in the development of TED. The medication is injected once every three weeks over six months and costs $14,900 per vial, and an entire course of treatment costs hundreds of thousands of dollars per patient. Horizon Therapeutics reported encouraging clinical trial results and said that the drug was shown to reduce proptosis (eye bulging). However, the European Group on Graves’ Orbitopathy recommended in 2021 that Tepezza only be used when other treatment options were unsuccessful. The organization cited a lack of long-term safety and efficacy data. Crucially, IGF-1 receptors are linked to cochlear development. The cochlea is part of the inner ear and plays a role in hearing.
Potential Tepezza Side Effects
The FDA requires pharmaceutical companies to share any foreseeable side effects with the public. On the label for Tepezza, the manufacturer warns of the potential adverse effects listed below:
- Muscle spasms
- Hair loss
- High blood sugar
- Hearing problems
- Taste changes
- Dry skin
While hearing problems are listed as a potential side effect, the drug’s safety information sheet says that it only happens in 10% of patients and makes no indication that the problems may be permanent. The manufacturer also does not mention tinnitus. Horizon Therapeutics maintains that Tepezza’s hearing damage is usually mild and reversible. In contrast, doctors have found that some Tepezza patients will have lifelong ear problems. Last year, the FDA received 93 adverse event reports related to Tepezza. Horizon did not modify the drug’s label to inform potential patients about the risk of long-term hearing damage or provide guidance for monitoring patients for hearing loss.
Horizon Therapeutics failed to warn physicians and patients that Tepezza could cause lifelong hearing problems. The manufacturer did not exercise reasonable care when testing the medication before it was released to the public and failed to share its link to tinnitus, making it impossible to work in severe cases. Horizon Therapeutics also didn’t instruct doctors on conducting audiological testing and did not provide prescribers with guidelines for identifying hearing loss.
If you’ve developed hearing problems after taking Tepezza, call Childers, Schlueter & Smith. We’ll fight for you to get reimbursement for your medical bills but also seek compensation for intangible expenses. Non-economic damages like mental anguish, pain and suffering, physical impairment, and a loss of quality of life can be considered when calculating damages. Contact our Tepezza attorneys for a free Tepezza claim consultation, or call us at (800) 641-0098 for more information.
At Childers, Schlueter & Smith, our attorneys are dedicated to helping victims of personal injury and/or those who have lost a loved one to wrongful death determine their legal options. We are a distinguished law firm that is driven by years of experience and exceptional results. If you or someone you know has been injured due to another’s negligence, please contact our firm to discuss your legal options.