Users of the pharmaceutical drug Tepezza have experienced complications, including hearing loss, thyroid eye disease flare-ups, and the need for a second treatment. Tepezza is supposed to help those suffering from thyroid eye disease, which causes inflammation and protrusion of the eye. The drug was fast-tracked to the market without proper testing by the Federal Drug Administration, which helped to hide some of the issues users have been facing.
Users of Tepezza have had to receive second treatments to deal with thyroid eye disease flare-ups caused by the disease’s progressive nature. Many Tepezza users have filed product liability lawsuits to hold the manufacturer, Horizon Therapeutics, accountable for failing to warn consumers of the issues the drug could present.
What is Tepezza?
Tepezza is a drug designed to treat thyroid eye disease (TED), which can cause inflammation in the eyelids, muscles, tear glands, and fatty tissues behind the eye. Thyroid eye disease is a rare condition that can lead to eye pain, trouble closing the eye, and double vision. Tepezza is administered as an injection by a healthcare professional in the vein, which is known as an intravenous injection. Those receiving the drug treatment will receive an injection eight times, with the injections happening once every three weeks.
Over the course of the six-month treatment process, those suffering from thyroid eye disease should experience relief from their symptoms. There should be a reduction in the eye bulge caused by thyroid eye disease, with less pain and vision difficulties caused by the disease.
The FDA Approved Tepezza in January 2020
The Federal Drug Administration (FDA) approved Tepezza on January 21st, 2020 as the first drug to treat adult thyroid eye disease. At the time, there was a lack of medical treatment options available for those with thyroid eye disease, which led to the Tepezza’s fast track to the market. It received an Orphan Drug designation, allowing it to hit the market without extensive testing.
Only two studies were conducted before the drug was approved by the FDA. While those studies found that Tepezza was effective in reducing proptosis, which is another term for eye protrusion, these were indications of adverse side effects. Some of the side effects found in these studies included hair loss, muscle spasms, headaches, diarrhea, fatigue, and hearing loss. Despite the long list of potential side effects, the drug was fast-tracked because it was the only drug that could help with thyroid eye disease.
New Study Finds Some Tepezza Users Experienced Thyroid Eye Disease Flareups
At the 91st Annual Meeting of the American Thyroid Association, Horizon Therapeutics, which is the manufacturer of Tepezza, presented data from a real-world analysis of the effectiveness of Tepezza. Horizon Therapeutics assessed deidentified claims data, which included 5,845 people living with thyroid eye disease who completed a full Tepezza treatment in 2020. They also looked at those who received a second Tepzza treatment before July 2022.
The study found that 15% of Tepezza users experienced a thyroid eye disease flare-up, which means that those unlucky users had to live with TED symptoms yet again. It is unknown what the cause of the re-emergence of thyroid eye disease could be, but it was speculated it could have to do with stress, pregnancy, and surgery. About 5% of the people whose data was assessed had to receive a second treatment of Tepezza due to their thyroid eye disease flare-up. Issues regarding hearing loss could arise in those that need a second treatment of Tepezza.
Stanford Researchers Found That a Large Portion of Tepezza Users Experienced Hearing Loss
A study published in the American Journal of Ophthalmology saw Stanford researchers look at 27 Tepezza users who had received at least four Tepezza injections. After following up 40 weeks later, they found that about 80% of the people involved in the study had experienced some form of hearing loss.
In August 2022, the American Academy of Ophthalmology released a review of the American Journal of Opthalmology study from Stanford researchers. The study found that of the patients involved in the study that suffered hearing loss, one-third still experienced hearing loss months after receiving Tepezza injections.
The issue that comes to light when you think of these studies along with the data presented by Horizon Therapeutics is the increased risk of hearing loss for Tepezza users. If someone needs to get a second treatment, they could be exposed to more risk of suffering hearing loss. No study has yet to be conducted to establish if a second treatment of Tepezza can be connected to hearing loss.
Tepezza Hearing Loss Lawsuits
Concerns over Tepezza causing hearing loss problems have to do with the drug being an insulin-like growth factor 1 receptor (IGF-IR) inhibitor medication. The insulin-like growth factor 1 receptor protects the ear’s inner hair cells from hearing damage, medication toxicity, and ischemia. Many allege that Tepezza should have known of the risks inherent in their drug due to how it can affect major parts of the ear. Horizon Therapeutics failed to warn consumers of the severity of hearing loss risks, which serves as the basis of Tepezza hearing loss lawsuits.
Horizon Therapeutics did warn of temporary hearing loss risks but did not disclose the permanent hearing loss some have suffered. Their failure to warn of potential hearing loss damages leaves them liable for product liability lawsuits. Victims can pursue compensation for damages caused by the use of Tepezza, including medical bills, lost wages, and pain and suffering.
Contact Dolman Law Group for Help With Your Tepezza Hearing Loss Lawsuit
Dolman Law Group is a personal injury law firm that has helped victims of personal injury incidents, such as slip and fall, motorcycle, and car accidents, recover compensation for damages. Our experienced product liability attorneys could help you recover compensation if you suffered damages from the use of Tepezza. They will assess your current and future damages, determine the liable party, negotiate a settlement with the at-fault party’s insurance company, and represent you in court. If you or a loved one have suffered hearing loss, tinnitus, or similar injuries after use of Tepezza then consider contacting Dolman Law Group's Tepezza lawyers about your case.