Tepezza Hearing Loss Side Effects May Be Reduced at Lower Doses: Case Report

Researchers indicate that a woman suffered both severe gastrointestinal problems and hearing loss from Tepezza, but the side effects resolved when the dosage was cut in half.

Side effects of the thyroid eye disease drug Tepezza have been linked to reports of severe and permanent hearing loss. However, a new case report suggests cutting the dosage in half may reduce the severity of hearing loss from Tepezza, while still provide effective treatment.

Tepezza (teprotumumab-trbw) is a new-generation biologic treatment introduced 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 the treatment has been shown to be effective, concerns have emerged over the past year about the risk of irreversible Tepezza hearing loss side effects, and the drug maker now faces a growing number of lawsuits that allege inadequate warnings were provided for user and the medical community about the importance of audiological monitoring during treatment. However, a new case report suggests lower doses may also help reduce the risk of hearing damage, while still providing an effective treatment for individuals with moderate-to-severe thyroid eye disease.

In a case report published last month in the medical journal Ophthalmic Plastic and Reconstructive Surgery, researchers from Stanford University describe the experiences of a 64-year-old woman who discontinued Tepezza due to significant hearing loss experienced after four infusions of the drug. She also suffered bilateral worsening of ear popping, loose bowel movements, which occurred up to 12 times per day, severe leg and hand cramping, loss of eyebrow hair and increased urinary frequency.

When she was taken off the drug, within two to five months both her gastrointestinal problems and hearing loss improved. However, after other treatments for her thyroid eye disease failed, she was placed back on Tepezza a year later at half strength. Despite the reduced dosage, the researchers report that her hearing stabilized. While her other gastrointestinal symptoms returned, the report indicate they were milder and more tolerable.

“She tolerated all infusions with an overall reduction in the severity of her adverse events and without return of significant sensorineural hearing loss,” the researchers concluded. “The authors conclude that a lower dose of [Tepezza] can be effective for patients with active moderate-severe thyroid eye disease who experience significant or intolerable adverse events.”

April 2023 Tepezza Hearing Loss Lawsuit Update

Although Tepezza was 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 pursue Tepezza settlements for hearing problems experienced, including persistent ringing in the ears known as tinnitus, and complete hearing loss. In many cases, the problems persist long after the thyroid eye disease treatments, leaving users with irreversible hearing damage.

The lawsuits claim Horizon Therapeutics, the manufacturer, should have been aware of the link between Tepezza and hearing loss before it was ever submitted to U.S. regulators for review, since the drug impacts the insulin-like growth factor I, which is known to play a central role in hearing and low levels have been shown to correlate with human syndromes associated with hearing loss. However, plaintiffs say the drug maker failed to adequately test Tepezza, ignored pose marketing reports that clearly indicated users were experiencing hearing loss, and provided false and misleading information about the safety risks with Tepezza, according to the complaints.

Given similar questions of fact and law raised in the complaints, last month a motion was filed to centralize all Tepezza claims over hearing side effects before one U.S. District Judge for coordinated pretrial proceedings as part of an MDL, or multidistrict litigation.

In complex pharmaceutical litigation, where large numbers of claims are brought by users of the same medication or medical product, each experiencing the same or similar injuries, it is common for the U.S. JPML to centralize the litigation to reduce duplicative discovery into common issues that will arise in all claims, avoid conflicting pretrial rulings and to serve the convenience of certain witnesses and parties who will be required to testify in each of the lawsuits.

As Tepezza hearing loss lawyers continue to review and file claims over the coming months and years, it is ultimately expected that several hundred lawsuits will be brought throughout the federal court system. If an MDL is established, each individual claim may later be remanded back to the U.S. District Court where it was originally filed for trial, if the parties fail to negotiate Tepezza hearing loss settlements or another resolution for the claims.