The facts about TEPEZZA and Hearing Issues
Please stay tuned for Important Safety Information about TEPEZZA at the end of this video.
If you have Thyroid Eye Disease, or T-E-D, you may be considering TEPEZZA for your treatment.
TEPEZZA is a prescription medicine used to treat Thyroid Eye Disease, No matter if you’ve had T-E-D for months or years.
One possible side effect of TEPEZZA is hearing issues. In this video, you’ll learn about the relationship between thyroid diseases and hearing issues.
And you’ll also hear the facts about what types of hearing issues patients experienced in the clinical studies of TEPEZZA.
For example, TEPEZZA may cause severe hearing problems including hearing loss, which in some cases may be permanent.
First, let’s look at how thyroid conditions, like Graves’ disease, can affect hearing.
Studies have shown that people who have thyroid conditions are at an increased risk for hearing loss, before receiving treatment.
In fact, in one study, about 1 out of 3 patients with thyroid conditions had mild to moderate hearing loss.
This is because thyroid hormones are needed for the development of hearing. So, imbalances in thyroid hormones may play a role in hearing issues.
Now, let’s review how treatment with TEPEZZA could affect hearing.
When considering a connection between hearing issues and TEPEZZA, it’s important to note that patients did not have hearing tests done before they started TEPEZZA in the clinical studies.
Therefore, pre-existing hearing problems were not considered in clinical studies.
That said, some patients taking TEPEZZA did experience hearing issues during the clinical studies.
The FDA approval of TEPEZZA was based on the first two clinical studies.
In those studies, about 1 out of every 10 patients taking TEPEZZA reported some kind of hearing issue.
In the most recent clinical study with patients who had Thyroid Eye Disease for 2 to 10 years, about two in ten patients taking TEPEZZA reported some kind of hearing issue.
When you hear the words “hearing issues,” you may think that this only refers to hearing loss, or deafness. While some hearing loss was one of the side effects experienced with TEPEZZA, “hearing issues” also refers to different types of less severe hearing problems.
The types of hearing issues reported were:
Hypoacusis, which is a general term for hearing loss that can affect one or both ears. With hypoacusis, a person can still hear, but not as well as usual.
Hearing loss or deafness, which means a partial or total inability to hear sounds.
Tinnitus (TIN-uh-tus), which is a ringing or buzzing sound in one or both ears.
Eustachian (you-STAY-kee-uhn) tube dysfunction, which means one of both ears feel like it is plugged with fluid.
And, finally, autophony, which is when it sounds like your own voice is too loud or echoing in your ears.
Across all of the clinical studies, only one person stopped taking TEPEZZA because of hearing problems. This person stopped when they discovered they had hearing problems that were related to an issue they were born with.
Now that you have the facts about how thyroid conditions and treatment with TEPEZZA are related to hearing issues, talk with your doctor about the risks and benefits of TEPEZZA.
TEPEZZA is a prescription medicine used to treat Thyroid Eye Disease (TED), no matter if you’ve had TED for months or years.
IMPORTANT SAFETY INFORMATION
What is the most important information I should know about TEPEZZA?
Infusion reactions can happen during or within 24 hours after your infusion of TEPEZZA. If you have a reaction while receiving TEPEZZA, your doctor or nurse will slow or stop your infusion and treat your reaction. If you have a severe infusion reaction, your doctor may stop your treatment completely.
Tell your doctor or nurse right away if you have any of these symptoms during or after your treatment with TEPEZZA:
- High blood pressure
- Fast heartbeat
- Redness of the face/Feeling hot
- Difficulty breathing
- Headache
- Muscle pain
If you have inflammatory bowel disease (IBD), such as Crohn’s disease or ulcerative colitis, TEPEZZA may make your IBD symptoms worse. Symptoms of worsening IBD may include: an increased number of loose stools with stomach pain or cramps, and blood in your stools. After each TEPEZZA infusion, tell your doctor right away if you have worsening IBD symptoms.
TEPEZZA may cause an increase in your blood sugar. Before starting treatment with TEPEZZA, tell your doctor if you are currently being treated for diabetes, know your blood sugar is high, or have been diagnosed with diabetes. It is important for you to take your treatments and follow an appropriate diet for glucose control as prescribed by your doctor.
TEPEZZA may cause severe hearing problems including hearing loss, which in some cases may be permanent. Tell your doctor if you have any signs or symptoms of hearing problems or changes in hearing.
Before receiving TEPEZZA, tell your doctor if you:
- Have inflammatory bowel disease (Crohn’s disease or ulcerative colitis).
- Are currently being treated for diabetes, have been diagnosed with diabetes, or know your blood sugar is high.
- Are pregnant or plan to become pregnant. TEPEZZA may harm your unborn baby. Tell your doctor if you become pregnant or suspect you are pregnant during treatment with TEPEZZA.
- Women who are able to become pregnant should use an effective form of birth control (contraception) prior to starting treatment, during treatment and for at least 6 months after the final dose of TEPEZZA.
- Are breastfeeding or plan to breastfeed. It is not known if TEPEZZA passes into your breast milk. Talk to your doctor about the best ways to feed your baby during treatment with TEPEZZA.
- Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, dietary and herbal supplements. Know the medicines you take. Keep a list of them to show your doctor and pharmacist when you get a new medicine.
What are the possible side effects of TEPEZZA?
The most common side effects of TEPEZZA include muscle cramps or spasms, nausea, hair loss, diarrhea, feeling tired, high blood sugar, hearing problems, taste changes, headache, dry skin, weight loss, nail problems, and changes in menstruation.
This is not a complete list of all possible side effects. Tell your doctor or treatment team about any side effect you may have.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/safety/medwatch, or call 1-800-FDA-1088.
Please visit TEPEZZA.com for more information.
You can watch more about side effects of TEPEZZA at TEPEZZAse.com or hear from a T-E-D Specialist during a live online event—register at EyesOnT-E-D.com.
