CHICAGO, IL – The U.S. Food and Drug Administration (FDA) approved Tepezza only three years ago, but mounting evidence shows the drug maker failed to adequately disclose all of the potential side effects. As a result, Tepezza warning were withheld from users and the medical community.
In July, the FDA finally approved a Tepezza label update which added important information the “Warning and Precautions” section, indicated that Tepezza may cause severe and permanent hearing loss. Doctors should test their patients’ hearing before and after Tepezza treatments while carefully weighing the benefits and risks with users.
Unfortunately, these new warnings come too late for former users who are left with permanent Tepezza hearing loss side effects, including:
- Permanent hearing loss
- Partial hearing loss
- Sensorineural hearing loss
- Tinnitus (ringing of the ears)
- Ear plugging sensation
- Among other hearing side effects
Tepezza was approved by the FDA in January 2020 giving Horizon Therapeutics the go ahead to market the drug to treat thyroid eye disease symptoms such as bulging, double vision and Thyroid Eye Disease (TED).
The FDA approval immediately drew criticism, including claims that clinical trials Horizon Therapeutics lacked ample population sizes among diverse groups of patients. Horizon began to market the Tepezza and generated sales in excess of $1 billion a year. Once users began to experience Tepezza hearing problems, it became clear the initial label warnings failed to provide critical information for not only users, but the medical community.
July 2023 Updated Tepezza Label Update
On July 20, 2023, the FDA issued an updated version of the prescribing information for Tepezza. The revised language now discloses the side effects users may experience including severe hearing impairment, which unfortunately, is now permanent hearing damage.
The language also highlights the importance of healthcare providers assessing patients by conducting a comprehensive evaluation of their auditory function prior to initial treatment, monitoring hearing through the therapy and reassessing any Tepezza hearing problems post-treatment.
Future users of Tepezza will now have an opportunity to make an informed decision to undergo infusions and minimize any risk of permanent hearing damage. However, thousands of individuals have received Tepezza since it was approved initially in 2020 and are left with irreversible hearing loss side effects that could have been prevented.
Our attorneys at the Dinizulu Law Group, Ltd. currently represent individuals who are now pursuing a personal injury and Tepezza hearing loss lawsuit, alleging that they may have avoided permanent hearing damage if the Tepezza label had accurately disclosed risks associated with the TED treatment when the drug was initially approved.
If you or a family member have experienced hearing loss or any other auditory complication after receiving a Tepezza injection, you may be eligible for a settlement or financial compensation. Even if you have questions about the Tepezza lawsuit, our team of skilled lawyers are here to help. Call our office anytime at (312) 384-1920 to schedule a free consultation today.