FDA Announces Warning Label Update Over Tepezza

FDA Announces Warning Label Update Over Tepezza

Introduction

Federal regulators have announced a warning label update over Horizon Pharmaceuticals' Tepezza which may cause severe and permanent hearing damage.

The drugmaker faces a growing number of lawsuits over Tepezza, alleging that the organization failed to adequately warn users or the medical community about risks associated with their new-generation thyroid eye disease treatment.

As the first treatment for bulging eyes and double vision brought on by thyroid eye disease, Tepezza was released in January 2020. These diseases, which lead to inflammation of the eye muscles, eyelids, tear glands, and fatty tissues behind the eye, are brought on by hyperthyroidism and are connected to Graves' disease.

Tepezza was first thought of as a niche medicine, but Horizon Therapeutics soon elevated the medication to a blockbuster level when it received approval, generating sales of more than $1 billion annually. However, questions regarding the possibility of Tepezza hearing adverse effects and whether the drug's manufacturer did enough study on their treatment or adequately explain the dangers that patients could have after treatment immediately surfaced.

The U.S. Food and Drug Administration (FDA) recently issued an updated edition of the Tepezza prescription information guide that includes a new section on the risks of severe hearing loss, which might sometimes be irreversible. Additionally, clinicians should check their patients' hearing before, during, and after Tepezza infusions, according to the updated Tepezza cautions about hearing loss.

After several former users filed product liability lawsuits against Horizon, claiming that Tepezza's adverse effects that were not sufficiently reported on the first warning labels had left them with irreparable hearing issues, the warnings update was released. Plaintiffs contend that if Horizon Therapeutics had given them early warnings regarding the need of monitoring their hearing both before and during treatments, they would have been able to prevent irreversible damage to their ears.

A new part of the FDA-approved Tepezza label has been added, and it carries virtually similar cautions to those that plaintiffs contend Horizon Therapeutics should have included when the medication was initially made available.

The new Tepezza label warning states that the medication "may cause severe hearing impairment, including hearing loss, which in some cases may be permanent." Assess the hearing of patients before, during, and after Tepezza therapy, and weigh the benefits and risks of patient care.

Despite the knowledge that Tepezza has been connected to irreversible hearing loss since its clinical trials, according to many lawsuits brought against the maker, Horizon Therapeutics, the business has fought efforts to include a warning about hearing loss on the label.

In recent research, it was shown that over 16% of people who used medication for thyroid eye illness experienced hearing issues, including hearing loss, tinnitus, autophony, and eustachian tube malfunction. This led to the amendment of the warning.