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Why Is Tepezza Prescribed?
Tepezza is a medication, teprotumumab, for treating TED — thyroid eye disease. If you have TED, your immune system creates inflammation that causes swelling behind your eyes. (1)
TED “can lead to disfigurement, debilitation, and permanent vision loss.” Teprotumumab is a “human monoclonal antibody that inhibits insulin-like growth factor-1 receptor (IGF-1R).” Tepezza is intended to improve “proptosis, diplopia, Clinical Activity Score, and quality of life in patients with TED.” (2)
Potential Tepezza Side Effects
Many patients have already experienced significant Tepezza side effects. Some of the most concerning are:
- Ongoing hearing loss or deafness.
- Tinnitus — ongoing ringing in the ears.
- Hypoacusis — partial or total loss of sharpness or acuity in understanding words.
- Autophony — loud hearing of your own voice.
- Muffled hearing.
- Ear-plugging sensation.
- Eustachian tube dysfunction.
This Eustachian tube dysfunction condition occurs when “the mucosal lining of the tube is swollen, or does not open or close properly.” If you experience this Tepezza side effect, your hearing may be muffled. You might also have to deal with pain, a ringing in your ear (tinnitus), a feeling of fullness in your ear, or balance problems. Reduced hearing is also possible. (3)
Serious Side Effects
There are many other serious Tepezza side effects that may occur. These include: (4)
- Diarrhea.
- Rectal bleeding.
- Abdominal pain.
- Cramping.
- Extreme thirst.
- Frequent urination.
- Extreme hunger.
- Blurred vision.
- Weakness.
Additional significant, but less intense, Tepezza side effects include: (5)
- Muscle spasms.
- Nausea.
- Hair loss.
- Fatigue.
- Changes in ability to taste food.
- Headache.
- Dry skin.
- Missed, irregular, or painful menstrual periods.
- Decreased weight.
- Change in appearance or color of nails.
Tepezza and Hearing Loss
The manufacturer of Tepezza aggressively marketed Tepezza for thyroid eye disease, downplaying signs of potential hearing loss and the fact Tepezza hearing damage could be permanent.
Tepezza failed to change the warning on its label until the FDA recommended a label change, despite a post-market study reporting that “more patients than previously reported may experience hearing symptoms such as hearing loss or muffled hearing,” stating “In two clinical trials conducted prior to FDA approval of the drug, otologic symptoms were reported in 10 percent of patients. The new study found the rate could be as high as 65 percent.” (6)
Results of another study about Tepezza demonstrated an even higher percentage of TED patients treated with teprotumumab who developed new otologic symptoms. This was as high as 81.5%. “Symptoms ranged from mild (the sensation of ear popping once per week) to significant declines in word recognition resulting in a change from serviceable to nonserviceable hearing.” (7)
Four of the six patients with persistent hearing loss began wearing hearing aids. Some patients “discontinued therapy because of otologic symptoms.” (8)
Even worse, less than 50% of patients who had noticed subjective symptoms of hearing loss “experienced symptom resolution” at a mean follow-up just shy of 39.2 weeks. (9)
Tepezza Warnings and Precautions
In addition to side effects leading to significant hearing damage, Tepezza comes with warnings. These include the possibility of: (10)
- Infusion reactions. Signs and symptoms of these reactions include temporary increases in blood pressure, fast heart rate, feeling hot, difficulty breathing, headache, and muscular pain. These reactions tend to occur during an infusion or within a couple of hours after an infusion.
- Inflammatory Bowel Disease Worsening: IBD is actually a term for two conditions: Crohn’s disease and ulcerative colitis. Both conditions “are characterized by chronic inflammation of the gastrointestinal (GI) tract.” Chronic inflammation can damage your GI tract. (11)
- Hyperglycemia. This refers to high blood sugar level. Chronic high blood sugar levels can damage your nerves, organs, tissues, and blood vessels. (12)
Legal Options
If you or a loved one suffered significant side effects after taking Tepezza to treat TED, you may be eligible to join the litigation against the manufacturer. Sadly, you are just one of many people who may have developed irreversible hearing damage, deafness, or tinnitus.
We are interested in hearing from anyone harmed by Tepezza. Now, you are facing not only serious vision impairment, but also may be facing permanent hearing damage.
Lawsuits against Horizon claim the company withheld data and analyses showing Tepezza could cause irreversible hearing damage, even as it was seeking market approval for the drug. All across the country, lawsuits are being filed.
If you or a loved one has sustained such injuries, you may be eligible to join the Tepezza litigation. We are a national firm that has nearly four decades of experience standing up to pharmaceutical giants, such as Horizon. We encourage you to reach out to us today.
One of our experienced defective drug attorneys can help you consider your legal options. This is what W&L attorneys are trained to do. Holding irresponsible companies accountable is what drives us.
Tepezza Side Effects and Multidistrict Litigation
People across the country are experiencing serious Tepezza side effects. Because the lawsuits filed against the manufacturer relate to the same Tepezza side effects injuries and have “common questions of fact,” the Court has approved of cases are being temporarily coordinated in one multidistrict litigation (MDL). This is to reduce “the burden on federal district courts, and make litigation more convenient for the parties and to promote overall efficiency in the courts.” MDLs “can sometime involve several thousand individual lawsuits.” (13)
How W&L Can Help
Weitz & Luxenberg has a long history of helping our clients hurt by defective drugs and due to the actions of large corporations. We have made it our mission to secure just and appropriate compensation for your injuries.
As a national law firm, Weitz & Luxenberg has been standing up to pharmaceutical giants across the country — whenever and wherever we are needed.
Our attorneys have won billions of dollars on behalf of our clients. Here are a couple examples of our major victories:
- Weitz & Luxenberg achieved a $13.5 million jury verdict for our client who sustained a debilitating fall while having a heart attack, brought on by the pain medication Vioxx.
- Weitz & Luxenberg secured $9 billion on behalf of our client who developed bladder cancer after taking Actos, a medication intended to alleviate diabetes.