Horizon Pharmaceuticals has been sued by a man in Arizona for allegedly failing to inform regulators that its thyroid eye diseases medication, Tepezza, can cause permanent ear ringing and hearing loss, according to an Aug. 25 report from Law360.
Daniel Weibel told the U.S. District Court for the Northern District of Illinois that he has suffered permanent hearing loss as a result of taking Tepezza for several months in 2020.
Mr. Weibel claims that Tepezza only received FDA approval because Horizon failed to disclose their data about hearing-related side effects.
Horizon earned $1.66 billion in revenue from the medication in 2021, according to court documents obtained by Becker's.
Mr. Weibel alleges that Horizon warns of "adverse hearing events" in 10 percent of patients on Tepezza's label, but says that only 100 patients were studied in clinical trials.
He also claims in the lawsuit that Horizon told the patients the hearing loss was temporary when it was not.
Mr. Weibel also alleges in the suit that several other physicians, researchers and patients have warned of hearing loss issues tied to the medication.
"[Horizon] should have changed the Tepezza label to include warnings and instructions addressing the risk of injury associated with the drug as soon as they had notice of adverse reports relating to the same," the suit reads.
"We are aware that a lawsuit has been filed by an individual plaintiff claiming to have been inadequately informed about the risk of hearing impairment from treatment with Tepezza," Geoffrey Curtis, Horizon's executive vice president of corporate affairs and chief communications officer, told Becker's in an Aug. 29 email. "Hearing impairment was identified as a potential adverse event in the Tepezza pivotal clinical trials, was thoroughly discussed at the FDA advisory committee meeting prior to the approval of Tepezza and is referenced in the Tepezza product label. We do not believe the lawsuit has merit and intend to vigorously defend it."
Mr. Weibel is suing Horizon for liability and negligence claims, seeking punitive and compensatory damages.