Concerning reports indicate the newly-approved Thyroid Eye Disease (TED) medication Tepezza could cause hearing loss and tinnitus. TED is the most common orbital disorder in adults, with a mid-adulthood onset. Following a series of trials, Teprotumumab (Tepezza) became the first FDA-approved therapy for TED. Despite FDA approval, scientific studies and anecdotal accounts reveal that many users are reporting hearing loss and other related hearing issues after taking Tepezza.

If you have taken Tepezza and experienced hearing loss, tinnitus, or another hearing condition, your condition may be caused by your Tepezza infusion treatment. Horizon Therapeutics PLC., the maker of the popular eye disease medication, maintains that most cases of hearing loss were “temporary and limited”; however, subsequent studies documented a much higher percentage of Tepezza patients with new hearing loss symptoms than previously reported. As we’ve discussed previously, patients who are injured as a result of a dangerous or defective product may be able to recover financial compensation from the company that manufactured the product. These product liability claims are crucial, not only to ensure consumers don’t end up paying out-of-pocket unnecessarily but also to encourage companies to thoroughly research their product prior to releasing them.

How Does Tepezza Treat Eye Disease?

Thyroid Eye Disease or Graves’ Disease is a progressive autoimmune condition that causes inflammation of the fatty muscle and tissue around the eye. Some people experience red and swollen eyes; in more serious cases, the eyes may bulge and cause blurry vision.

Horizon Therapeutics (“Horizon”) claims that Tepezza uses a biologic inhibitor to help decrease eye bulging and prevent tissue from forming behind the eye. Tepezza is administered by a healthcare provider as an intravenous (IV) infusion therapy into a vein once every three weeks for eight treatments.

Does Tepezza Have Serious Side Effects?

The FDA approved Tepezza as a viable treatment for Graves’ Disease in 2020 after only two clinical trials. According to the manufacturer, Tepezza may cause infusion reactions such as increased blood pressure, headache, overheating, and muscular pain. In addition, Tepezza can increase the likelihood of inflammatory bowel disease (IBD) flare for those with preexisting IBD. Further, Tepezza can increase blood glucose, and patients may experience hyperglycemia. Most notably, the company explained that the most common adverse reactions are muscle spasms, nausea, alopecia, diarrhea, and hearing impairment.

In addition to these side effects, some patients report suffering from hearing loss after taking Tepezza.

Clinical Trials Show Tepezza May Cause Irreversible Hearing Loss

In addition to the multitude of possible side effects and adverse reactions for those taking Tepezza, one of the most alarming side effects is potentially irreversible hearing loss. While the manufacturer reports mild to moderate side effects, a groundbreaking study from Stanford University claims to have determined that there are more significant and long-lasting reactions to Tepezza than previously reported.

In conjunction with anecdotal reports, the study showed that using Tepezza may cause serious hearing dysfunctions, such as:

• Hearing loss,

• Tinnitus (ringing in the ears),

• Autophony (a heightened perception of one’s bodily sounds), and

• Ear plugging sensation.

Stanford University researchers presented their findings at the Endocrine Society’s annual meeting. The researchers reported that 65% of Tepezza users had hearing disorders after taking the medication. Specifically, 23% of patients experienced subjective hearing loss, 27% developed tinnitus, 12% experienced ear plugging sensations, and 29% reported heightened hearing of their voice. Most people develop these symptoms about halfway through their therapy course.

Can You Suffer Long-Term Hearing Problems After Using Tepezza?

Based on recent studies and reports from patients who claim to experience Tepezza hearing loss, the long-term impact of taking Tepezza may cause significant challenges. These hearing issues are even more troubling as the people using this medicine already face vision problems.

Several of the patients in the study with new hearing symptoms had new or worsening sensorineural hearing loss. Sensorineural hearing loss can occur when a Tepezza patient experiences damage to the hair cells in their inner ear. Moreover, other patients developed a patulous eustachian tube. Usually, the eustachian tubes remain closed and open to regulate pressure around the ear drum. Patulous eustachian tube is a disorder that causes the channels between the ear, nose, and throat to remain open. Finally, other patients claim to have experienced sensorineural hearing loss. Researchers reported that while a few patients experienced improvement three months after stopping the medication, many continue to report experiencing the adverse effects of Tepezza.

Tepezza Hearing Loss Lawsuits

Many dangerous drug lawsuits stem from a failure to warn, instruct, advise, educate or otherwise inform patients and consumers of the drug’s adverse effects.

For instance, a Tepezza user recently filed a complaint alleging that he developed permanent hearing loss after receiving Tepezza infusions. The plaintiff asserts that Horizon withheld the extent of hearing loss problems associated with using Tepezza. He argues that this failure to warn caused many users to suffer tinnitus and other serious hearing loss conditions. Further, the plaintiff alleges that the company failed to update its warnings to reflect these findings despite post-marketing safety studies indicating a risk of hearing loss.

The company maintains that it could not have modified the Tepezza warning label unilaterally. The company purports that the plaintiff failed to assert plausible claims for failure to warn and design defects under state law. However, as more Tepezza users realize the extent of their hearing loss, the company will likely have to face a rising number of product liability claims.

Product liability attorneys are reviewing Tepezza hearing loss and tinnitus claims. Lawyers can help those who have suffered hearing loss after using Graves’ disease medication to determine whether they are eligible for a Tepezza lawsuit settlement.