What Is Thyroid Eye Disease? Do Treatments Cause Harmful Side Effects?

What Is TED?

Thyroid eye disease (TED) is a progressive inflammatory disease that affects the muscles and soft tissue around the eyes and is associated with hyperthyroidism, or an over-active thyroid condition. 

Jessica Hanson, who suffers from the condition said that the scary reality of the illness is your own appearance.

“Do you know what it’s like to wake up and not recognize yourself in the mirror?” asks Hanson. “To have this happen so often that you forget what you looked like before?”

Unfortunately, this is just one aspect of the condition, which can include varied experiences from person to person.

TED is a rare eye condition, which impacts between 15,000 and 20,000 patients in the U.S. Studies show that women are impacted more than men and tend to have more severe symptoms. The same studies have found that middle age, a median age of 49.2, is the average age of the patient suffering from the condition.

TED is typically experienced as a result of hyperthyroidism. Hyperthyroidism is a condition in which the thyroid produces more thyroxine than is needed by the body. Graves’ disease is an autoimmune condition and the most common cause of the overactive thyroid, or hyperthyroidism. 

Graves’ disease occurs when antibodies that attack the thyroid gland. The disorder makes antibodies misinterpret the thyroid’s actions as an “attack” and combat this by fighting the thyroid. The body’s immune system turns against the thyroid gland, which causes the thyroid to become overactive. 

However, only about one quarter of those suffering from Graves’ disease will experience TED symptoms. TED, which is also an autoimmune disease, happens when those antibodies attack the back of the eye. This in turn causes inflammation. It can also, in some patients, cause the eye to be pushed forward to appear as a staring or bulging of the eyes.

Some of the most common symptoms include eyes and eyelids becoming swollen and red. Others experience swelling or stiffness of the area around the eye, particularly in muscles involved in eye movement. This muscle tension can cause the eyes to misalign with one another, causing double vision.

It is very rare, but possible, for TED to cause blindness. This occurs when the pressure on the nerve at the back of the eye becomes too great. Some also can form an ulcer on the front of the eye, impairing vision.

There is no set timing with TED. While suffering from Graves’ disease, TED can happen along with it at any point in the progression of the illness. Most feel mild symptoms, but others can experience distressing and disfiguring changes which can be hard to treat.

*NOTICE: As an expert in assessing eligibility in defective drug claims, Miguel Leyva contributed to this article. Aiming to get financial compensation for Tepezza-related hearing impairment and associated damages, Leyva helps TED patients to understand their legal rights and chances for compensation through Atraxia Law, a San Diego-based firm. MedShadow does not partner, with nor profit from, any law firm or its filed suits. We wish to notify readers of this conflict of interest, as Leyva and his firm do have a financial interest in the suit and its potential results.

Smoking and TED

Studies have shown that smoking can worsen TED symptoms, and that those that smoke may respond more slowly to treatment. A smoker is eight-times more likely to get TED than a nonsmoker. Because smoking reduces the amount of oxygen in the body’s tissues,  it has been shown that the reduced oxygen content makes tissues in the back of the eye prone to inflammation.

Overall, experts have determined, if you smoke, your chance of developing TED is doubled. If you have radioactive iodine treatment and you smoke, you are four times more likely to develop TED. Additionally, smoking will lessen the impacts of treatments, as your tissues will heal more slowly due to a lack of oxygen.

Who Treats TED?

With such a rare and complex disease, it can be difficult to know where to start. Most general ophthalmologists are not trained to treat TED. Likewise, few endocrinologists alone can manage the multifaceted struggles of TED specifically.

Instead, many specialized clinics take a team approach. Lilly Wagner, M.D., is an oculoplastic surgeon. She says that it takes a team to manage each patient’s unique TED experience at Mayo Clinic’s Thyroid Eye Disease Clinic.

“During their visit to the Thyroid Eye Disease Clinic, patients are evaluated by an oculoplastic and orbital specialist, a strabismus surgeon, an endocrinologist, and an ENT (ears, nose, and throat) surgeon,” says Dr. Wagner. “The goal of the visit is for patients to gain an excellent understanding of their disease process, to get an idea what their course may be over the next month or even years, and to learn about different treatment options that are available to them.”

This team of doctors with such varied specialities gives patients the opportunity to take a personalized approach to their condition. Because the illness varies greatly in its presentation (patients may have very unique experiences and symptoms), you may need to consult multiple doctors concerning your TED symptoms.

How TED Is Treated

There are multiple ways that TED may be treated by your doctor. Because the condition has various stages, there can be various methods of treating the symptoms. Overall, the goal is to ease the pain or improve the quality of life from those suffering.

Over-the-Counter Options 

Some over-the-counter (OTC) medications can help to alleviate the symptoms of TED. For example, your doctor may recommend simple eye drops to help to lubricate a dry or gritty-feeling eye. These saline-based solutions may ease the scratchy or irritated eye sensations caused by TED.

According to Penn Medicine’s website, some patients have found relief by adding a Selenium supplement to their diet. Ask your doctor if such OTC methods might help your condition.

Surgical Treatment

Though usually a last resort due to the risks involved, there are surgical procedures that can alleviate the pain and vision challenges that come along with TED. Some surgical options include:

• Decompression surgery
• Eye muscle surgery
• Eyelid surgery

Each of the surgeries focuses on a different aspect of the condition. Decompression surgery removes bone and tissue behind the eye, which allows for more space. Just as the name implies, this “decompresses” the pressure in the eye socket. Eye muscle surgery is typically an option for those with severe double vision as a result of TED. Eyelid surgery is to allow for the improvement of the eye’s lid, allowing the appearance and function of the lid to better. This can reduce the “bulging” appearance of the eye.

Prescription Medications

A variety of drugs can be used to treat the symptoms of TED. Presently, three drugs have commonly been used to provide relief for those with the condition:

• Steroids
• Neuromuscular blockers
• Monoclonal antibodies

Steroids, or corticosteroids, are a hormone-based drug which aims to reduce inflammation. Prednisone is the most often prescribed, though it is known to have an array of side effects which can outweigh the benefits of the prescription.

Neuromuscular blockers are medications that aim to stop nerve signals from the muscle to the brain. Drugs of this nature, such as Botox (botulinum toxin), are most commonly used to treat a misalignment.

Monoclonal antibodies are a drug that is categorized as a “disease-modifying drug” (DMD). It  works by “acting” like a protein made naturally by your immune system. The medication tries to mimic the protein and replace the harmful ones, attacking your eye, or the cause of TED. As of 2022, Tepezza is the only drug therapy approved by the FDA to treat TED.

Lifestyle Modifications

Many doctors work to balance the thyroid itself in order to lessen the severity of TED symptoms. Hyperthyroidism is the root cause of this autoimmune disorder, so managing its production of hormones or its imbalances can help to  alleviate TED symptoms. 

Marius Stan, MD, is an endocrinologist with the Mayo Clinic. He says that managing the thyroid can be a central key to managing TED and its symptoms. 

“Many of these (TED) patients have an overactive thyroid, a condition called Graves’ disease, but that is not always the case,” says Dr. Stan. “Some patients have normal thyroid levels or even low thyroid levels. Normalizing thyroid hormone levels is important for overall health: heart, bone, and other organs. But, it is also important for the eye disease itself.”

He also said that working with multiple doctors with open communication is key.

“Some of the medications we use for Thyroid Eye Disease can affect other endocrine functions, like glucose control,” says Dr. Stan. “Thus, these medications are best managed through a multiple-disciplinary team.”

Those that smoke are encouraged to quit, as the impacts worsen the condition. 

As with most autoimmune disorders, TED causes inflammation. In order to decrease this issue, patients are often encouraged to eat an Anti Inflammatory Diet. Foods can decrease inflammation and thus reduce symptoms and their severity.

Still others find that lifestyle alterations are best managed by tracking symptoms. “Flare Tools” such as these can allow the person to track what conditions cause flare ups or worsened symptoms. Because each person’s body is so unique, what causes your symptoms to worsen may not impact another TED patient. Tracking your own, personal experience with the illness can help you manage your specific journey.

What Is It Like To Have Thyroid Eye Disease

Amyleigh Foster said she had been diagnosed with hypothyroidism at age 16. It wasn’t until she was taking selfies in her late 30s that she began to notice something wasn’t quite right with her eyes.

Difficulty Diagnosing TED

“I had moved so I saw a new doctor and she came into the room and said, ‘What’s wrong with your eye? I need you to get your labs done right now. There’s something going on,’” says Foster. That’s when she found out her hypothyroidism was going into hyperthyroidism, forcing a more careful adjustment of her medication (levothyroxine). 

During her care, Foster says that it was not a major, noticeable thing to strangers, but she could tell something was off. She suffered, missing sometimes two days per week of work, with terrible headaches, which began to take as much of a mental and emotional toll as it was physical. Finally, she was able in January 2020 to find a more integrative doctor who diagnosed her with Hashimoto’s disease.

“Hashimoto’s thyroiditis” is an autoimmune condition that slowly destroys the thyroid. It is the most common cause of hypothyroidism in the U.S., and is often found in patients with a genetic history of thyroid problems in the family.

Foster says she had to continue to advocate for herself until she found a doctor that would really listen.

“I was told by my doctors at the time that there was nothing I could do about TED or my thyroid issues and for a while I believed them and just kept deteriorating,” she says. “I was uninsured and biologics weren’t options. When I finally reached my breaking point I went looking for a functional doctor who helped me by running a full thyroid panel. Can you believe that even with a TED diagnosis I had never had a full thyroid panel? He diagnosed me with Hashimoto’s and prescribed T3. He also took me off traditional thyroid meds and prescribed compounded medication that is additive free.”

Foster didn’t give up.

“I started to educate myself on autoimmunity and realized I was going to have to heal myself,” she said. “My body was sending up alarms that it was in serious trouble, and I was the only person who could do the work to get better. I realized that this illness was a turning point in my life, and that I had a lot of healing I had been needing to do my entire life that I had been resisting.”

Instead of giving up, Foster decided on some lifestyle changes while she continued to seek a physician that might have solutions.

“I started by making lifestyle changes and went on the autoimmune protocol diet which gave me relief within six, or so, weeks,” she says. “I was in bed three to four days a week with migraines. I had stabbing pain in my eyes, exhaustion, itchiness, miserable digestive issues, anxiety, and they all started to improve [with lifestyle changes]. The bulging in my eyes slowly reversed as I removed allergens and stress from my life, and I started to look more like my old self.”

A Change of Diet

Once Foster had clarity about her condition, she decided on an autoimmune disorder diet.

“I eliminated grains, dairy, legumes, refined sugar, alcohol, and nightshade foods,” she says of her eating habit changes. “I also stay away from most oils except avocado, coconut, and olive oil.”

Foster saw improvements within the first few weeks.

“I started feeling better within a month,” she says. “After one month, I had only a few migraines. After three months, a lot of the eye swelling was gone, and I had zero migraines. Also, my weight dropped.”

The diet and lifestyle changes took Foster plenty of hard work, but the handling of her condition brought her also to a new career choice. Instead of the restaurant industry, Foster now has her own Hashimoto’s Coaching business, to help others battle the brain fog, weight, and anxiety symptoms of the condition. You can find out more at her website here. You can also find Foster’s full story here about her experiences with TED.

An Emotional Toll

Jessica Hanson said that her challenges with TED were emotional and mental.

“I no longer recognized myself in the mirror,” she says. “Who was that person whose eyes looked so strained and painful? I stopped using mirrors as much as possible. Photos became incredibly triggering. I untagged myself in several alarming-looking pictures on social media, then began dodging cameras altogether.”

Though she has had many surgeries to help with her pain, she said that the impacts people could not see were just as difficult as those they could. 

“The emotional journey isn’t over,” says Hanson, who is currently in remission from her TED struggle. “Will I always examine photos and question if my eyes look normal enough? Will I ever be carefree, smiling for the camera with my friends, and not wonder if my eyes look scary? Will I ever feel like me again?”

Hanson says that working on the emotions of the disease is critical. Though currently her symptoms are controlled, her eye damage cannot be reversed.

“As I’m working on getting acquainted with the new me, in the back of my mind there will always be a twinge of anxiety,” she says. “Thyroid eye disease is a lifelong condition, and there is so much that is unknown. Though I’m currently in the “inactive” phase, my symptoms could resume at any time.”

Foster agrees that the emotional toll of the illness was difficult to overcome.

“I really struggled with my diagnosis,” says Foster. “It felt like as soon as there was a label my health and my eyes really started to deteriorate and that I had ZERO control over what was happening to me. Both of my eyes started bulging, but especially my right. They pointed in opposite directions and my eyelids retracted.”

Beyond the cosmetic impact, Foster says being in pain makes it all the harder to deal with the physical and emotional hurdles.

“My body was inflamed, my joints hurt, and I was suffering from debilitating migraines three to four days a week,” says Foster. “I had just purchased a house by myself, a huge milestone in life, and I couldn’t even be proud of myself or happy about it. “

Foster says that the illness began to make her feel terrible about her own self image. These symptoms made it even harder to find quality care.

“My self worth was deeply affected,” says Foster. “I had always been the heavy girl with a ‘pretty face’ and now, not only did I not recognize the person in the mirror, but living with chronic pain impacted my productivity and what I believed about myself,” she says. “During this time, I experienced a lot of medical gaslighting and because my self worth and efficacy was so low I had a really difficult time advocating for myself.”

Foster says that her dedication to herself really is what made the difference. She would tell others suffering to also keep trying! Make the lifestyle changes and commit to treating your body with pride, and you can make a difference in your condition.

“If you have control over just one thing it’s how well you treat your body!” says Foster. “As I have healed, my hormones have begun to balance, I’ve reduced systemic inflammation and calmed my digestive issues. I’ve lost 70 pounds, improved my sleep and got my energy and enthusiasm for life back!”

It isn’t an easy road, but Foster credits her dedication to her better state of health.

“This journey has been incredibly profound,” she says. “It changed who I am, how I see myself and ended up changing my career as well!”

Now, Foster dedicates her career to helping others figure out how to balance their hormones and health choices.

“I now get to help 100s of women figure out what’s going on with their health and how to fix it,” she says. “As a Functional Health Coach, I specialize in helping women recover from chronic illness, thyroid, gut and autoimmune disease by getting to the root of the problem through functional testing, real food and lifestyle change.”

What Is Tepezza? 

Tepezza is a prescription medication to treat TED. The medication is delivered via infusion, which must be done by a healthcare professional in an office setting. The treatment includes a series of eight injections given every three weeks until the course is completed. 

Each injection session lasts from 60 to 90 minutes for the patient to get the full dose. Hearing loss was noted in clinical trials, along with other side effects of the medication.

Tepezza’s serious side effects include:

•  infusion reactions
• worsening of inflammatory bowel disease
• high blood sugar

The most common side effects of Tepezza that were noted in trials included:

• muscle spasm
• nausea
•  hair loss
• diarrhea
• fatigue
• high blood sugar
• dry skin
• change in taste
• headache

Technically speaking, the only prescription drug to specifically treat TED is Tepezza (teprotumumab-trbw) infusion, created by Horizon Therapeutics in early 2018 and approved by the U.S. FDA in early 2020. While other prescription medications and therapies can slow the symptoms, Tempezza is the only to focus on the root cause of the condition.

Despite being a niche drug for a rare disease, Tepezza was widely prescribed and was on the fast lane to becoming the blockbuster drug of Horizon. However, a mere year after receiving FDA approval, the manufacturer started facing criticism for its lack of proper warning on its label regarding hearing loss as being an adverse effect with a high rate of occurrence.

Partial or Permanent Hearing Loss Is a High-Occurrence Side Effect of Tepezza

Warnings issued in the Tepezza Prescribing Information listed hearing impairment as a reversible adverse effect of the Tepezza infusion treatment with a risk of occurrence of 10%. With a low rate of occurrence, this was a risk that TED patients seeking relief from the symptoms from their burdening condition were willing to take. 

Unfortunately, what looked like an informed decision for doctors and their patients, became a reason for concern as soon as reports of severe hearing-related complications as an immediate effect of Tepezza infusion treatment started to emerge.

• The first study to draw attention to an alarming discrepancy between the warnings of the manufacturer and research findings concerning hearing loss risks was conducted by a team of researchers at Stanford University and was presented virtually at the annual meeting of the Endocrine Society in January 2021. This study found that 65% of the patients who participated in the testing process developed hearing-related adverse effects, with some of the auditory symptoms persisting months after the conclusion of the Tepezza infusion treatment.
• Further studies confirmed the suspicion that Tepezza users might pay too high a price for the treatment of TED. Auditory symptoms resulting from treatment with the Tepezza IV infusions included muffled hearing, plugged ear sensation, tinnitus, autophony, sensorineural hearing loss, eustachian tube dysfunction, and even permanent hearing loss. Some findings showed that hearing impairment due to Tepezza treatment might affect 81.5% of the Tepezza patients.

The Stanford study, however, only included 26 patients, of which 17 experienced hearing-related difficulties. The study included those that had had at least four injections of the medication. These patients were also only followed for three months, and the Endocrine Society noted that more follow-up would be necessary to understand the lasting effects of Tepezza on hearing.

Tepezza Users May Experience a Decrease in Their Quality of Life Due to Permanent Hearing Loss

Suffering from permanent hearing loss or tinnitus and the effects these have on the quality of life is not an outcome that TED patients who accepted Tepezza infusion treatment should have to face, especially when the warning does not fit the findings accurately.

• The frustration of not being able to have unimpeded conversations with friends, family, and coworkers is only a starting point, but as it affects the quality, length, and deepness of these conversations. Hearing loss may lead to a sensation of isolation and mental health issues such as severe depression and anxiety. Impeded communication ability may lead to broken marriages, loss of friendships, and even jobs. Such depression and anxiety may also lead to a need for more medication, meaning more potentially harmful side effects.
• A major downside of permanent hearing loss is losing access to some enjoyable moments in life. Missing out on how the voice of the loved ones sounds, what feelings the sounds of nature evoke, or on the peace of mind that only music can offer, deprives permanent hearing loss patients of sources of enjoyment.
• Safety is yet another serious concern. Missing the sound of smoke alarms, that of a fast-approaching car, or the sound of heavy machinery at the workplace can all result in health-endangering scenarios that make living alone or working independently challenging.

If you developed permanent hearing loss, tinnitus, or other auditory symptoms following a Tepezza infusion treatment, you have the option to speak to legal counsel. If you are eligible for a Tepezza lawsuit, you can get rightfully compensated for the impact of hearing impairment on your life.

Horizon Faces Liability Lawsuits for Failing to Adequately Warn About Hearing Loss Associated With Tepezza Use

According to legal experts, there are two essential aspects in regards to which Horizon failed to adequately warn about when it chose to overmarket Tepezza infusion treatment:

• the high risk of hearing impairment as an adverse effect
• the seriousness of hearing damage that may occur

Opting for Tepezza infusion treatment, knowing that hearing loss is a reversible effect with a risk of 10%, is an entirely different scenario from having to face a risk of 65% of permanent hearing loss due to treatment. By minimizing the hearing loss risks involved, the manufacturer left no room for patients or doctors to make an informed decision. According to some law firms, Horizon “can and has to be held accountable for the failure of adequate warning.”

Further filings relatively quickly followed the first Tepezza lawsuit filed in Arizona in August 2022. As of March 2023, 34 Tepezza lawsuits are being filed in federal courts nationwide. As there is an increasing number of reports sent to the U.S. FDA about tinnitus, hearing loss, and even deafness that occurred after treatment with Tepezza infusion, tens to hundreds of Tepezza lawsuits are expected to be filed in the upcoming few months.

With no settlement yet, only speculations can be made about the financial compensation Tepezza users can get from the manufacturer through a Tepezza lawsuit or claim. Compensation calculations consider the economic and non-economic damages suffered due to a life-altering condition such as permanent hearing loss.

Those With Tepezza-Related Hearing Loss May Seek Legal Help

As with many drugs that cause adverse effects in patients, a class-action lawsuit has begun regarding Tepezza. In the unfortunate event of Tepezza-related hearing loss or tinnitus in your own, personal journey, legal assistance is typically required to find out more information. To find out if you are eligible for a Tepezza lawsuit, you must speak to a legal representative. Determining eligibility is a complex process in which several factors are considered, a few general guidelines apply to all cases. You may be eligible if you:

• were prescribed Tepezza infusion for the treatment of thyroid eye disease
• have received one or more Tepezza infusions
• have subsequently been diagnosed with partial or permanent hearing loss or tinnitus

MedShadow Foundation does not partner with, nor profit from, any law firm or its suits. Readers are always encouraged to research facts independently and consult their own legal counsel if they feel the need for advice. MedShadow does not provide legal advice. Class-Action Lawsuits are simply noted to inform our readers of legal actions involving a medication.