When taking medication, the first thing we do is read the side effects. If prescribed by a doctor, sometimes we omit reading the fine print because they’re the experts. We trust their word. Somehow Tepezza managed to fly under the radar for quite some time.
Tepezza was given FDA approval in 2020. Touted as a miracle drug to treat Thyroid Eye Disease (TED), many patients put their trust in it, hoping the medication would live up to the hype.
TED is an autoimmune disease. The condition is connected to an over-active thyroid gland as a result of Graves’ disease. Penn Medicine says a quarter of patients with Graves’ disease end up developing TED.
Treatment for mild cases includes eye drops and Selenium supplements. Tepezza was marketed as the only drug that treated the source of TED and not just the symptoms.
Never mind the side effects; those were minor details… until the first Tepezza lawsuit was filed. From muscle cramps to nausea to hearing loss. How could such significant factors have been ignored by drugmaker Horizon Therapeutics?
Lawsuit Incoming
Initially, patients were astounded at the outcomes. Not only did Tepezza decrease the symptoms of TED, but the medication was also hailed as “potential for a brighter future.”
The possible side effects of the drug were listed as high blood sugar, hair loss and hearing problems. These symptoms weren’t just minor inconveniences. These symptoms weren’t just minor inconveniences. Hearing loss for instance turned out to be a much bigger issue.
Cynthia Williams was one of the first to take on Horizon Therapeutics. She alleged that the drug’s flawed design led to her hearing loss and tinnitus.
Soon other patients followed with similar claims. A shocking percentage of patients who received Tepezza suffered from hearing loss and other hearing problems, according to TorHoerman Law.
Plaintiffs in the Tepezza lawsuit claim that the biopharmaceutical company failed to warn them about the potential risks of the drug. As of July, there are 138 filings in the Tepezza hearing loss lawsuit.
Tepezza Label Update
The FDA approved a Tepezza label update in 2023 on indications and usage. This was to include unrestricted access for patients across the complete spectrum of TED, reported Pharmaceutical Technology.
In the same year, the public health body issued an update on the warning label to cover hearing impairment or hearing loss. Exacerbation of preexisting hyperglycemia and inflammatory bowel disease were added to the precautions.
The wording on the label reads: “Tepezza may cause severe hearing impairment including hearing loss, which in some cases may be permanent.”
Three Years Too Late
The FDA’s warning may have come three years too late. With a slew of evidence stacked up against Horizon Therapeutics, one wonders how Tepezza was approved in the first place.
A study published by the NIH ran a series of trials. About 46% of patients complained of hearing symptoms. Uutophony and hearing loss or muffled hearing were some of the indicators. The symptoms reportedly developed after receiving 3.6 infusions of Tepezza.
BMJ Journals shared a case report of a woman in her 50s who suffered tinnitus following three doses of teprotumumab (Tepezza). After the fifth dose, she experienced “frank hearing loss”.
Her audiogram was significantly worse when compared to her baseline test before treatment. However, she showed no improvement following the halt of Tepezza.
The study authors did recommend regular audiometric testing before, during and after Tepezza therapy. They proposed potential treatment to reverse the hearing loss effects.
In phase 4 of the Tepezza clinical trial, nine patients claimed they had suffered hearing impairment. The drugmaker said “conductive hearing loss” occurred in the double-masked period.
As it stands, Tepezza lawyers are hopeful the lawsuits may be resolved by negotiating settlements with Horizon Therapeutics.
Debora Welch Klostermann filed her lawsuit in the District Court for the Northern District of Illinois last year. Like others, she claimed Horizon Therapeutics should have known Tepezza when used as prescribed could cause hearing loss.
In response to the court action, Horizon Therapeutics said they believed the lawsuits were without merit and intended to vigorously defend themselves.
The company referred to an FDA advisory committee meeting before Tepezza’s approval. It added that hearing impairment as an adverse event was thoroughly discussed and included in the product label.
There’s one thing the rise in the Tepezza hearing loss lawsuits has taught us. It’s that people are becoming more aware of the drug’s potential side effects. That’s probably worth more than winning any lawsuit.
