In the summer of 2022, patients who underwent treatment for an eye illness through an FDA-approved drug are now suffering from severe hearing damage and hearing loss after a biopharmaceutical company failed to inform doctors of the risk behind their drug. Tepezza®, also known as teprotumumab, is a prescription drug that was developed by Horizon Therapeutic® to help treat a condition known as Graves' eye disease and thyroid eye disease (TED).
TED is a condition that occurs when the eye muscles, tear glands, eyelids, and the fatty tissue behind the eyes become inflamed. The eye inflammation is triggered by an abnormal autoimmune response and can cause the eyes to swell and obstruct vision. When administered, Tepezza® works by blocking a specific protein that is believed to be the cause of the development of TED. Tepezza® is administered through injection about every three weeks for roughly five months. However, those who have taken Tepezza® are now filing lawsuits after taking the drug and suffering from hearing loss in one or both ears.
Research Shows Tepezza® Is Six Times More Likely to Cause Hearing Loss
As previously mentioned, in January 2020, during the FDA review and approval process for Tepezza®, Horizon claimed to acknowledge that the drug presented some risk of hearing damage as a possible side effect. According to their reports, while Horizon did inform the FDA of the potential risks, they also stated that the hearing loss would only be "temporary and generally of limited duration" and had occurred in less than 10% of patients. After gaining FDA approval, Tepezza® was released into the U.S. market, and soon after reports came flooding in from patients and doctors of severe hearing damage after starting use of the drug.
Then, in March 2021, studies showed that not only had Horizon severely understated the severe risks associated with hearing damage or loss with Tepezza® but that Horizon had also downplayed how severe the hearing damage could be with continued use. Along with the understated information behind the drug's side effects severity, the study also discovered that 65% of patients who were on Tepezza® reported some form of hearing loss, damage, or ringing in the ears. This is roughly six times higher than the original estimated risk of hearing loss disclosed by Horizon during the FDA approval process. While Horizon claims that they had given enough information about the potential issues with hearing loss, their post-marketing studies suggest that Tepezza® has a much higher risk of causing permanent hearing damage or loss than what was previously reported.
Lawsuits Are Launched Against Horizon
According to the lawsuits, the labels on the drug did not warn patients or doctors about the potential risk for hearing loss or tinnitus, nor did it warn how these issues could be permanent to those taking the eye drug. Horizon claims to have somewhat acknowledged in its warnings that the potential for hearing damage was a potential side effect of Tepezza® transfusions. However, as the lawsuits claim, the warnings provided by Horizon were grossly inadequate due to the level of understanding behind the risk of hearing loss or damage, and they did not advise medical professionals nor patients about the high risks when taking the drug or if usage should have been monitored during treatments. The lawsuits claim that Horizon knew or should have known about the potential risks of their drug.
Join the Fight With Morgan & Morgan
In order to qualify to file a Tepezza® lawsuit, you must have taken the drug and have experienced permanent or persistent hearing loss. The best way to understand if you qualify to file a claim against Horizon Therapeutics® is by speaking to a Tepezza® attorney as soon as possible. Depending on your state of residence, there may be a statute of limitations for filing a claim, ranging from two to four years on average.
If you suspect that you may have lost your hearing after taking Tepezza®, do not wait to speak with an attorney. To follow along with this case or to learn more information regarding the Tepezza® lawsuits and how you may be eligible to file, contact Morgan & Morgan today by completing our free, no-obligation case evaluation form today.