Case Study Links Tepezza Side Effects to a Potential Risks for Diabetics

Report decribes a patient who suffered diabetic ketoacidosis that was likely caused by side effects of Tepezza, leading researchers to warn that the thyroid eye disease drug could pose serious risks for diabetes patients

A new case study raises additional concerns about potential side effects of Tepezza, indicating that the thyroid eye disease drug may increase certain health risks for users with diabetes.

Researchers with the Atrium Health Carolinas Medical Center in North Carolina warn that Tepezza infusions can have a hyperglycemic effect, increasing the odds that diabetics may lose glycemic control and face heightened risks of diabetic ketoacidosis. Their findings were published on September 19 in a case report in the medical journal Endocrine.

Tepezza (teprotumumab-trbw) is a new-generation biologic treatment introduced by Horizon Therapeutics in January 2020, as the first medication approved to treat thyroid eye disease or bulging eyes, which is caused by hyperthyroidism and linked to Graves’ disease, resulting in inflammation of eye muscles, eyelids, tear glands and fatty tissues behind the eye.

Although Tepezza infusions were originally intended as a niche treatment, with only a limited market, during the second year the drug was on the market in the United States, sales doubled to $1.66 billion, and critics have expressed concern that Tepezza was aggressively marketed without adequately disclosing all of the potential risks.

Hundreds of former users are now coming forward to report that they experienced various hearing loss Tepezza side effects, including persistent ringing in the ears known as tinnitus, and other hearing problems. In many cases, the hearing loss persists long after the thyroid eye disease treatments, leaving users with irreversible damage to their ears.

This latest research was spurred by prior findings that suggested Tepezza has a hyperglycemic effect, because it impacts insulin-like growth factor-1 receptors. The researchers warn that in some cases, this can lead to a “dramatic response” resulting in loss of diabetes control.

The case study centered on a single patient who suffered an acute episode of diabetic ketoacidosis, which doctors linked to severe hyperglycemia caused by Tepezza side effects.

Diabetic ketoacidosis (DKA) occurs when high levels of blood acids, known as ketones, build up in the body. This can result in symptoms like difficulty breathing, nausea, vomiting, abdominal pain, confusion, fatigue or sleepiness, often requiring hospitalization, urgent medical treatment, and potentially resulting in severe health consequences.

After stopping Tepezza infusions, the patient was prescribed insulin and taken off of the thyroid eye disease drug. According to the findings, the patient’s glucose levels and blood sugar levels are now stable using just the drug metformin; a frontline type 2 diabetes treatment.

The patient decided not to continue Tepezza use due to its hyperglycemic effects.

“While additional research is needed as to the cause of severe hyperglycemia in patients, providers should consider proactively monitoring glucose throughout treatment with teprotumumab by ensuring that patients have baseline labs at every visit and access to a glucometer with education for its use,” the researchers concluded.

Tepezza Hearing Loss Lawsuits

The call for additional monitoring mirrors allegations raised in a number of Tepezza hearing loss lawsuits, which indicate that plaintiffs could have avoided permanent damage if the drug makers had warned doctors to monitor patients’ hearing while on the thyroid eye disease drug.

The U.S. Food and Drug Administration (FDA) recently released a new version of the Tepezza prescribing information guide, which now adds many of the same hearing loss warnings plaintiffs indicate should have been included when the drug was first introduced.

The new Tepezza label update now discloses that users have been left with severe and permanent hearing loss. It also indicates doctors should assess patients’ hearing before, during, and after Tepezza infusions, to avoid users experiencing permanent ear damage.

Given common questions of fact and law raised in complaints filed in federal courts nationwide, a Tepezza MDL (multidistrict litigation) was established in July, centralizing the lawsuits before U.S. District Judge Thomas Durkin in the Northern District of Illinois for coordinated discovery and pretrial proceedings.

As part of the coordinated management of the litigation, it is expected that Judge Durkin will establish a “bellwether” program, where a small group of representative cases will be selected to go through case-specific discovery in preparation for early trial dates, which will help the parties gauge how juries are likely to respond to certain evidence and testimony that will be repeated throughout various cases in the litigation.

While the outcome of Tepezza bellwether early trial dates will not be binding on other claims in the litigation, the average lawsuit payouts may influence eventual Tepezza settlement negotiations that will be necessary to avoid each individual case being set for trial in the coming years.