Tepezza Injection Hearing Loss Lawsuit
Injectable prescription drug Tepezza (teprotumumab)—a medication used to treat thyroid eye disease (TED)—has recently been linked to health concerns including hearing side effects, permanent hearing loss, and tinnitus, or ringing in the ears.
Manufacturer Horizon Therapeutics Ireland DAC received FDA approval for the drug on January 21, 2020, when an advisory committee unanimously recommended the medication’s approval for the treatment of adults with thyroid eye disease.
Recent research, however, has found that patients taking the drug may have an increased risk of permanent hearing loss. Horizon Therapeutics now faces Tepezza lawsuits brought by plaintiffs who claim to have taken the drug and then experienced hearing problems.
The defective product liability lawyers at Chaffin Luhana are currently investigating cases in which patients were injected with Tepezza and then developed hearing loss or tinnitus.
Give our experienced Tepezza attorneys a call today to schedule a complimentary consultation at 1-888-480-1123.
What Is Thyroid Eye Disease (TED)?
Graves’ disease is an autoimmune disease that affects the thyroid and often the skin and eyes. It’s caused by a malfunction in the immune system and is more common in women than in men.
The thyroid is a butterfly-shaped gland at the base of the neck that secretes hormones that regulate metabolism, heart rate, body temperature, and blood pressure. In those with Graves’ disease, the thyroid enlarges (goiter) and produces too much thyroid hormone (hyperthyroidism). Symptoms include rapid heartbeat, profuse sweating, high blood pressure, irritability, fatigue, weight loss, and hair loss.
Some people with Graves’ disease also develop TED because the faulty immune system attacks the eyes. TED can also occur in those with an overactive or underactive thyroid. It causes progressive inflammation and damage to the tissues around the eyes, particularly the extraocular muscle (muscles that control eye movement), connective tissue, and fatty tissue.
Symptoms of TED include:
- Gritty feeling in the eyes
- Swelling or abnormal positioning of the eyelids
- Watery eyes
- Bulging eyes (proptosis)
- Double vision (diplopia)
- Blurred vision
- Misalignment of the eyes (strabismus)
- Chronic bloody eyes
- Intolerance of bright lights
- Difficulty moving the eyeballs
The active phase of the disease can last anywhere from 6 months to 2 years, after which the progression stops, but symptoms may remain. In severe instances, vision loss can occur. Progressive damage to the tissues around the eyes can lead to scarring (fibrosis) and tissue remodeling. The extent of the scarring usually becomes noticeable after the inflammation and swelling have subsided.
It’s common for symptoms to range from mild to severe depending on the person. In some people, the condition doesn’t change much for many years, while in others, it may worsen or even slightly improve.
Unfortunately, there is no cure for TED. Treating the thyroid usually doesn’t help slow the progression of the eye disease. Doctors focus on easing the symptoms instead and provide treatments focused on preserving sight and the integrity of the cornea.
What Is Tepezza?
Tepezza is the first and only treatment approved by the FDA (Food and Drug Administration) for thyroid eye disease. Healthcare practitioners administer the injections to patients once every three weeks for a total of eight infusions. The drug has been shown to help improve protrusion of the eyes, double vision, soft tissue inflammation, and quality of life.
The FDA approved the drug based on the results of two studies consisting of 170 patients with active thyroid eye disease who were randomized to either receive Tepezza or a placebo.
In the first study, 71 percent of patients who received Tepezza demonstrated a greater than 2-millimeter reduction in proptosis (eye protrusion) compared to 20 percent who received a placebo. In the second study, 83 percent of patients who received the drug experienced the same improvement, compared to 10 percent of those who received a placebo.
In those original studies, however, one of the side effects of the drug was hearing loss. Horizon Therapeutics later reported that hearing-related adverse events occurred in 9.5 percent of patients treated with the drug versus 0 percent who received a placebo. Horizon characterized these effects as “mild to moderate and reversible.”
Other common side effects included the following:
- Muscle spasm
- Alopecia (hair loss)
- Hyperglycemia (high blood sugar)
- Dry skin
- Dysgeusia (altered sense of taste)
At the time of the approval, Wiley Chambers, M.D., deputy director of the Division of Transplant and Ophthalmology Products in the FDA’s Center for Drug Evaluation and Research, hailed the medication:
“Today’s approval marks an important milestone for the treatment of thyroid eye disease. Currently, there are very limited treatment options for this potentially debilitating disease. This treatment has the potential to alter the course of the disease, potentially sparing patients from needing multiple invasive surgeries by providing an alternative, non-surgical treatment option.”
Tepezza works by inhibiting or blocking the activity of the protein insulin-like growth factor-1 (IGF-1), which is believed to play a significant role in the development of the disorder.
The FDA fast-tracked the drug through the approval process because it was intended for a rare disease. Its development was also in part supported by the FDA Orphan Products Grants Program, which provides grants for clinical studies on the safety and efficacy of products for use in rare diseases or conditions.
How is Tepezza Linked to Hearing Loss?
Beginning in 2021, some new studies came out that linked Tepezza with an increased risk of hearing loss.
In March 2021, for instance, The Endocrine Society reported on one of them. A single-center study presented at the ENDO 2021 conference suggested that more than half of the patients with TED treated with Tepezza developed otologic (related to the ear) symptoms.
The study was small, involving less than 30 patients. Yet 46 percent of those receiving 4 Tepezza infusions reported hearing loss symptoms, which was much higher than the 10 percent of patients who developed hearing symptoms in the original trials used to gain the drug’s FDA approval. The most common symptoms were subjective hearing loss, tinnitus, ear plugging sensation, and autophony (loud hearing of one’s own voice).
“Hearing dysfunction has been described as a side effect in 10 percent of patients in the randomized clinical trials,” the researchers wrote. “Our results demonstrate a much higher percentage of teprotumumab-threated thyroid eye disease patients with new otologic symptoms than previously reported…”
Based on the study results, investigators urged clinicians to be aware of the potential for hearing symptoms among patients receiving Tepezza for TED.
How is Tepezza Linked to Hearing Loss?
Researchers later followed up on those patients involved in the 2021 study, analyzing 27 patients after infusions 2, 4, and 8, and at the 6-month follow-up visit. They found that 22 of them (81.5 percent) had developed new hearing symptoms after receiving about 4 infusions of Tepezza.
At the last follow-up visit after the last infusion, most patients (68 percent) with symptoms like tinnitus, ear plugging/fullness, and autophony no longer experienced those symptoms—they had resolved. Only 45 percent of those with hearing loss/decreased word comprehension, though, experienced resolution.
Three patients who developed hearing loss related to their intake of Tepezza were still suffering from hearing loss at the last follow-up. Two patients required hearing aids. Researchers also found that a prior history of hearing loss was a risk factor for Tepezza-related hearing loss.
The researchers concluded that “hearing loss is a concerning adverse event of teprotumumab” and should be further studied. “Until risk factors for hearing loss are better understood,” they added, doctors should screen patients with hearing tests and repeat those tests if hearing symptoms develop.
How Would Tepezza Negatively Affect the Ear?
As to why Tepezza would cause ear problems, scientists point to its effect on insulin-like growth factor 1 (IFT-1).
“IGF-1 plays a critical physiologic role in the ear,” researchers stated in a 2022 editorial commenting on the 2022 follow-up study. It is critical for the protection of nerve cells, healing noise-induced hearing damage, reducing swelling, and preventing medication toxicity.
Scientists noted in a 2017 study that an IGF-1 deficiency “leads to profound sensorineural hearing loss [SNHL] both in humans and mice.” (SNHL happens when there is damage to the inner ear.) Its also been shown to correlate with age-related hearing loss.
In an earlier 2014 study, scientists noted that IGF-1 “is one of the growth factors that are involved in the development of the inner ear,” and that it may be used to treat SNHL. When comparing human subjects with SNHL treated with IGF-1 to those in a control group, the proportion of patients showing hearing improvement was significantly higher in the IGF-1 treatment group at 24 weeks.
Another 2017 study of over 4,300 participants over 50 years old found that higher levels of IGF-1 seemed to confer some protection against hearing impairment in some older adults. And in a 2021 study, scientists found that nearly half of patients with SNHL treated with IGF-1 experienced some degree of recovery after six months.
Considering these and other studies, it may be that Tepezza’s action to suppress IGF-1 could potentially lead to hearing loss in some people.
Common Injuries Related to Tepezza
Tepezza is related to several side effects, including those listed above. It may also result in:
- A feeling that the ears are plugged
- Autophony (perception that one’s own voice is too loud or echoing)
- Eustachian tube dysfunction
- Hyperacusis (oversensitivity to a range of sounds)
- Hypoacusis (hard to hear clearly)
- Hearing loss
- Tinnitus (ringing in the ears)
- Permanent hearing loss
The first Tepezza lawsuits were filed in mid-2022 by plaintiffs who were treated with the medication and then developed hearing loss injuries.
These plaintiffs claim that the manufacturer failed to provide adequate warnings about the risks of hearing loss, and misrepresented the drug’s association with lasting hearing problems. They also note that the manufacturer failed to adequately research the drug and its connection to hearing loss before releasing it on the market.
Frequently Asked Questions
Does Tepezza Cause Hearing Loss?
Studies have linked treatment with Tepezza to hearing symptoms. These studies have been small so far, but the results are compelling. Scientists have urged further studies to determine just how much of a risk Tepezza poses to healthy ear function.
How Long Does Tepezza Hearing Loss Last?
It’s still unclear how long hearing loss related to Tepezza may last. So far, in studies, it seems to resolve itself in many patients after they stop taking the drug. But some patients continue to suffer from hearing loss long after that, with a few having to obtain treatment in the form of hearing aids.
In a 2022 case report, for example, a 61-year-old woman with Graves disease and TED received treatment with Tepezza. She developed bilateral hearing loss, sound distortion, and tinnitus. An audiogram at her doctor’s office showed mild to moderately severe SNHL.
She returned for another test at 4 months after stopping Tepezza treatment. Her results were unchanged, leading doctors to determine that her hearing loss was irreversible.
Future studies should shed more light on this question.
Who Should Not Take Tepezza?
Researchers have warned healthcare providers to screen patients for potential hearing symptoms or hearing loss before prescribing Tepezza. Though we don’t know for sure yet, it appears that those who are already at risk for hearing loss may be more vulnerable to Tepezza-related hearing problems.
Am I Eligible for a Tepezza Lawsuit?
If you received Tepezza treatment for thyroid eye disease and you subsequently developed hearing symptoms like hearing loss or tinnitus, you may be eligible to file a Tepezza lawsuit. Talk to a Tepezza attorney about your options.