Tepezza Side Effects May Increase Risk of Hyperglycemia: Study
Amid growing concerns that the side effects of Tepezza may cause permanent hearing loss, a new study now warns the thyroid eye disease drug may also increases the risk of hyperglycemia, causing potentially dangerous increases in blood sugar levels.
Tepezza (teprotumumab-trbw) is a biologic treatment approved by the FDA in January 2020, as the first drug approved to treat thyroid eye disease, which is caused by hyperthyroidism and linked to Graves’ disease, causing inflammation of eye muscles, eyelids, tear glands and fatty tissues behind the eye. Commonly referred to as bulging eye disease, this condition can cause blurred or double vision.
The FDA approved Tepezza through a fast-track Orphan Drug designation, which allowed the drug maker to introduce the injection without extensive testing, since it targeted a condition which has no other treatment available. However, over the few years that the injection has been on the market, information about a number of potential Tepezza side effects have begun to emerge.
A number of studies and case reports have been published over the last two years, which identified a link between Tepezza and hearing problems, which critics indicate the manufacturer knew or should have known about.
Horizon Pharmaceuticals now faces Tepezza lawsuits brought by former users, who indicate that signs of the problems were apparent during clinical trials and should have been disclosed to users and the medical community. The lawsuits allege that if information and warnings had been provided about the importance of monitoring for hearing loss, many users may have avoided permanent Tepezza problems.
Late last month, new concerns emerged when a study was published late in The Journal of Clinical Endocrinology & Metabolism, warning the side effects of Tepezza may increase the risk of hyperglycemia, particularly in patients who already have diabetes.
Stanford researchers already knew the drug was linked to the condition, since it is known to inhibit insulin-like growth factor-I receptors. However, they sought to define the incidence and severity of the problem, as well as how it could be managed. They conducted a longitudinal, observational study which looked at all patients treated with Tepezza at one institution from March 2020 to May 2022.
According to the findings, 52% of the patients taking Tepezza developed hyperglycemia. Of those, 55% of cases were mild, 41% were moderate, and 5% were considered life-threatening. The researchers also found age, pre-existing diabetes, and having Hispanic or Asian ethnicity were significant risk factors for Tepezza hyperglycemia.
In earlier randomized clinical trials, hyperglycemia appeared to occur in only 10% of patients, the researchers noted.
“While effective, teprotumumab carries a significant risk of hyperglycemia, especially in patients with diabetes,” the researchers concluded. “Hyperglycemia may persist after stopping teprotumumab. These findings underscore the importance of guidelines for screening and management of teprotumumab-related hyperglycemia.”
December 2022 Tepezza Lawsuit Update
While no Tepezza lawsuits have been filed over hyperglycemia problems, at least two complaints have been brought by former users who allege they were left with hearing loss following use of the drug.
The first Tepezza hearing loss lawsuit was filed in August 2022, by Daniel Weibel, who indicates that he was left with permanent damage after receiving intravenous infusions of the drug from June 2020 through September 2020.
That complaint was followed by a second lawsuit filed in November 2022, alleging that Tepezza side effects caused irreversible hearing loss for Donna Walker, after receiving infusions from June 2020 through November 2020, Walker alleges that the drug maker misrepresented the safety of their medication, suggesting that reports of hearing loss were moderate and reversible, which has not been the case for many users.
As more individuals learn that hearing loss problems may be the result of Tepezza side effects, it is expected that dozens of additional lawsuits may be filed against the drug maker in the coming months and years.
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