In the past few years, as a result of several studies conducted since the drug was introduced to the market, Tepezza (teprotumumab-trbw) has been under scrutiny for its association with hearing loss risks.
Unfortunately, links between the drug and other harmful adverse effects are also starting to emerge.
A study conducted by a group of researchers at Stanford University and published in October 2022 in the Journal of Clinical Endocrinology and Metabolism, has drawn attention to another potential health risk as a side effect of Tepezza infusion treatment, the risk of hyperglycemia. One important finding of the study is that Tepezza patients with preexisting diabetes are more likely to develop potentially dangerous, even life-threatening high blood sugar levels.
Approved by the FDA with an orphan drug status in January 2020, Tepezza is presently the only prescription drug that got approved for the treatment of thyroid eye disease (TED). Orphan drug designation is meant to encourage drug manufacturers to invest in developing treatment drugs for rare diseases, also called orphan diseases.
TED, also known as Grave's eye disease or commonly also mentioned as bulging eye disease, is a rare disease, defined in the October 2022 study as a"potentially sight-threatening and disfiguring autoimmune disease". Since orphan drug designation permits a faster approval process with no extensive testing, there were basically only two pre-approval clinical trials conducted by the manufacturer.
Based upon data provided by these clinical trials, Horizon Pharmaceuticals, the manufacturer of Tepezza infusion treatment warned future patients and doctors about various adverse effects, among which both hyperglycemia risks and hearing loss risks were stated to have an occurrence risk of 10%. According to the October 2022 study, however, risks of hyperglycemia developing or aggravating as a side effect of the treatment with Tepezza infusion may be alarmingly higher than 10%. Of the 42 patients observed in the study for a period of 47.5 weeks, 52% developed hyperglycemia, and of these cases:
The study also concluded that hyperglycemia may persist even after the Tepezza infusion treatment is stopped and that factors such as age, preexisting diabetes, or Hispanic/Asian ethnicity are significant risk factors in Tepezza-related hyperglycemia.
The situation is no better when hearing loss risks are observed. In a study by Stanford University study presented in January 2021, 65% of the patients observed developed hearing-related adverse effects. The most common otologic symptoms patients complained about were:
Other adverse effects were also observed, such as:
Despite these adverse effects being labeled by the manufacturer as being mild and reversible, according to the study, that is not always the case. Some of these may persist even after the Tepezza treatment is concluded and may cause life-long health damage. This conclusion raises the same safety questions as the high risk of occurrence for hearing-related Tepezza side effects does.
Findings revealed in both studies mentioned above are alarming and question the safety of Tepezza infusion treatment. Both permanent hearing loss and aggravated hyperglycemia are prices too high to be paid for the treatment of TED. While further studies need to be conducted in order for the public to have a deeper understanding of the impact that Tepezza infusion treatment may have on overall health, it is already clear that Horizon Pharmaceuticals has failed to adequately warn future patients and doctors about hyperglycemia and hearing loss risks involved with the use of the drug.
While no hyperglycemia Tepezza claims have been filed yet, the process of holding Horizon Pharmaceuticals accountable for insufficient information regarding hearing loss risks associated with the use of the drug has already started. Two Tepezza lawsuits have already been filed (one by Daniel Weibel in August 2022 and a second one by Donna Walker in November 2022) and it is most likely that many more will follow.
Our team at Atraxia Law can be the first step to help you in your quest to seek compensation for hearing loss suffered as an adverse effect of Tepezza infusion treatment. Before being referred to the attorney or law firm best suited for your individual case and specificities, you will have a relaxed, quick, and effective consultation with us. Our team will go over the details of your situation to gain a clear understanding of your needs and will determine if you are eligible to file a Tepezza claim. We have already, successfully helped individuals involved with challenging personal injuries, with their cases resulting in a cash payout.
If you have no preexisting hearing loss history prior to your Tepezza infusion treatment, but you have been diagnosed with partial or permanent hearing loss or tinnitus after your Tepezza treatment, you may be eligible to seek compensation through a Tepezza claim.
Tepezza claims have a statute of limitations that differs in different states and for this reason, it is essential that you contact our team at Atraxia Law as soon as your Tepezza-related hearing loss diagnosis has been established.