Tepezza and Hearing Loss - Bernstein Liebhard LLP

Were you diagnosed with Thyroid Eye Disease (TED)?

How many Tepezza infusions have you received?

What injury are you or a loved one suffering?

Full Name: Email Address: Phone Number:

The U.S. Food & Drug Administration approved Tepezza (teprotumumab) in 2020 under the Fast Track and Breakthrough Therapy Designation protocols.

Tepezza is manufactured by Ireland-based Horizon Pharmaceuticals and is the only medication approved to reduce the eye bulging and double vision associated with Thyroid Eye Disease (TED). The drug also improves symptoms related to the condition, including redness, swelling, and eye pain.

In March 2021, the U.S. Food and Drug Administration (FDA) issued a safety communication regarding hearing loss and balance disorders linked to Tepezza usage, highlighting multiple reported cases of hearing loss and tinnitus among patients undergoing the treatment.

Injuries May Include:

Hearing loss
Tinnitus (ringing in ears)
Clogged/plugged ear sensation
Balance Issues
Clicking or ringing noise in the ear
Deafness including sensorineural deafness,
Dizziness
Hyperacusis - a type of reduced tolerance to sound
Hypoacusis - a partial or total loss of hearing acuity
Muffled hearing
Autophony (unusually loud hearing of a person's own voice)
Vertigo
Patulous Eustachian tube dysfunction (a disorder of the valve of the Eustachian tube that causes it to remain open)
Pulsatile Tinnitus (Rhythmic thumping, whooshing, ringing, or throbbing in ears)
Sensorineural hearing loss (SNHL)- Soft sounds may be hard to hear. Even louder sounds may be unclear or may sound muffled

Horizon Therapeutics, the manufacturer, is facing an increasing number of lawsuits related to hearing damage. In response to the similarity of issues raised in various complaints filed across U.S. District Courts, a group of plaintiffs sought to establish a Tepezza MDL (Multidistrict Litigation) specifically for hearing loss lawsuits in 2023.

In complex pharmaceutical litigation, where numerous claims arise from the use of the same medication or medical product, often leading to similar injuries, it is customary for the U.S. JPML (Judicial Panel on Multidistrict Litigation) to centralize the legal proceedings. This consolidation aims to avoid redundant discovery processes for common issues that will arise in all claims, prevent conflicting pretrial rulings, and enhance the convenience of witnesses and parties required to testify in multiple lawsuits.

Consequently, a panel of federal judges has decided to consolidate all Tepezza-related hearing loss lawsuits from the federal court system. These cases will be subject to pretrial proceedings before a single U.S. District Judge in Illinois, as part of the multidistrict litigation (MDL) process.

Unfortunately, a growing body of research published since Tepezza’s approval suggests that up to 65% of patients who receive Tepezza infusions may suffer hearing-related side effects. And contrary to the findings in clinical trials, these side effects appear irreversible in many cases.

For example, according to a recent study published in The Lancet, hearing loss was one of the most commonly reported adverse events in two Tepezza trials involving patients treated at 28 specialty centers.

In May 2021, another study published in the Journal of the Endocrine Society indicated that 46% of patients receiving four or more Tepezza infusions had reported issues with hearing, including:

Hearing loss
New tinnitus (ringing of the ears)
Ear plugging or muffled hearing
Autophony (the unusually loud hearing of an individual’s own voice)

An additional 23% of patients experienced a sensorineural hearing loss that had yet to resolve three months after stopping Tepezza infusions. The study authors characterized the hearing loss as a “concerning adverse event” that “should be further studied.”

A third study analyzing hearing dysfunction in 27 patients treated with Tepezza found that 81.5% developed new subjective otologic symptoms, including tinnitus, ear plugging/fullness, autophony, and hearing loss/decreased word comprehension. Three of the five patients who developed sensorineural hearing loss experienced persistent subjective hearing loss at their last follow-up.

That paper, which appeared in the American Journal of Ophthalmology, was written in part by a consultant for Horizon Therapeutics and an individual who has served on the corporation’s advisory boards.

Tepezza infusions for Thyroid Eye Disease (TED) linked to hearing problems. – there’s no question now that it’s on the label and lawsuits have been filed!

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