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FDA Updates Tepezza Warning Label Amidst Lawsuits

Riddle Brantley LLP   |  August 2, 2023   |  

Tepezza’s Updated Warning Label

The FDA has updated teh warning label for Tepezza due to potential hearing loss risk.The U.S. Food and Drug Administration (FDA) has recently updated the warning label for Tepezza, a drug used to treat thyroid eye disease (TED). The new label now includes a section that highlights the risk of severe hearing impairment, including permanent hearing loss, a warning that plaintiffs claim in Tepezza hearing loss lawsuits should have been provided by Horizon Therapeutics, the manufacturer of Tepezza, when the drug was first introduced.

To be clear, Horizon Therapeutics strongly denies any negligence and/or liability related to plaintiffs’ claims.

The New Warning

The updated Tepezza label now states:

“Tepezza may cause severe hearing impairment including hearing loss, which in some cases may be permanent. Assess patients’ hearing before, during, and after treatment with Tepezza and consider the benefit-risk of treatment with patients.”

This warning echoes the concerns raised by plaintiffs in recent and ongoing lawsuits against Horizon Therapeutics. At Riddle & Brantley, we are investigating these claims and anticipate that the updated warning label will potentially impact the outcome of these cases.

“We are concerned by the new FDA warnings related to Tepezza and potential hearing damage. Potential victims are entitled to justice.”

-Gene Riddle, dangerous drugs attorney, Riddle & Brantley

Tepezza and Hearing Loss: A Known Risk?

Despite the alleged link between hearing problems and Tepezza, Horizon Therapeutics had resisted calls to add a hearing loss warning to the label. A recent study published in the medical journal Endocrine Practice observed that many patients who took the thyroid eye disease drug suffered hearing problems, including hearing loss, tinnitus, autophony, and eustachian tube dysfunction.

Lawsuits Allege Negligence by Horizon Therapeutics

Lawsuits filed against Horizon Therapeutics allege that the drugmaker knew or should have known about the potential for Tepezza to cause hearing loss. The Thyroid Eye Disease treatment works by blocking a protein called IGF-1R, which may harm hair cells responsible for hearing and balance. These hair cells play a crucial role in detecting sound waves and transmitting them to the brain, and their damage can lead to hearing loss and other auditory issues.

The lawsuits claim that Horizon Therapeutics failed to conduct proper follow-up or disclose the potential side effects. We are actively investigating these claims and are committed to seeking justice for potential victims.

What It Means for You

The FDA’s decision to update Tepezza’s warning label is a significant development in the ongoing legal battle surrounding the drug’s side effects. As lawsuits continue to be filed, the focus will remain on Horizon Therapeutics and its alleged failure to warn patients and healthcare providers about the potential risks associated with Tepezza. The addition of this new warning label is a step towards ensuring patient safety and informed decision-making in the medical community.

Do You Qualify for a Tepezza Lawsuit or Claim?

Have you suffered from hearing problems after taking Tepezza for Thyroid Eye Disease (TED)? You may qualify for compensation in a Tepezza lawsuit. Our firm is actively investigating these claims. For a FREE, no-obligation case review, please call 1-800-525-7111 or complete the fast and easy form below. There are never any upfront costs and you won’t pay any attorney fees unless we win your case and you receive compensation.