Tepezza Hearing Complaints Known By Drug Maker For Years Before Warnings Provided, According to Lawsuits

Former users allege that Horizon Therapeutics was aware of long-term Tepezza hearing complaints years before a warning label update in July 2023

Although Horizon Therapeutics just introduced Tepezza about three years ago, there is increasing evidence that suggests the drug manufacturer knew about an alarming number of hearing loss complaints among users of their thyroid eye disease infusions, yet failed to provide adequate warnings about the potential Tepezza hearing risks to patients and the medical community until a few months ago.

Dozens of former users are now pursuing Tepezza hearing loss lawsuits, each raising similar allegations that they may have avoided permanent damage if the drug maker had disclosed information it had from adverse event reports and warned about the importance of monitoring for damage during and after Tepezza infusions.

In July 2023, a new Tepezza warning label update was announced, adding some of the same language that plaintiffs maintain should have been provided when the medication was first introduced. However, rather than disclosing information to potential users and the medical community years earlier, lawsuits allege that Horizon made misleading statements and withheld details about the Tepezza hearing complaints being experienced by users in real-world settings.

In this featured post, AboutLawsuits.com will explain allegations being presented in lawsuits brought by former users throughout the U.S., and provide information about complaints submitted by users who were left with permanent hearing complaints from Tepezza.

Tepezza Hearing Loss Risks Were Known Since Clinical Trials

Tepezza (teprotumumab-trbw) was the first FDA-approved drug specifically for the treatment of thyroid eye disease (TED); a rare condition where the muscles and fatty tissues behind the eye become inflamed. This can lead to symptoms like bulging eyes, double vision, pain, and potential vision loss. Thyroid eye disease is often associated with Graves’ disease, an autoimmune disorder that causes hyperthyroidism, or overactive thyroid.

Prior to Tepezza, treatments for TED often revolved around addressing the symptoms or underlying causes of the disease, such as using corticosteroids to reduce inflammation or surgical procedures for more severe cases. However, these treatments did not specifically target the mechanisms believed to be at the heart of TED.

Tepezza was granted Orphan Drug Designation by the FDA in May 2013,  which is given by the FDA to medications and biologics that are intended for the safe and effective treatment, diagnosis, or prevention of rare diseases/disorders that affect fewer than 200,000 people in the U.S. The drug was later put on the agency’s Fast Track designation 2016, to help expedite its development and review of potential benefits it could bring to patients with thyroid eye disease (TED), a condition that had limited specific treatment options at that time.

By January 2020, the FDA granted Tepezza market approval for the treatment of thyroid eye disease (TED) based on clinical trials that consisted of less than 200 participants total, which is a decision that has been highly criticized in recent years by individuals claiming the population size was not large enough to fully understand the scope or severity of potential side effects.

Despite the limited clinical trial data, lawsuits filed in recent months now point out complaints that suggest Horizon was aware of hearing-related side effects during clinical trials, which the manufacturer categorized as temporary, and told the FDA would resolve within several months of stopping treatment.

Tepezza Clinical Trials vs Real World Side Effect Rates

During the preliminary clinical trials presented to the FDA, Horizon’s data indicated a mere 10% chance of temporary hearing issues from Tepezza. However, later findings reveal that the actual rates of hearing side effects from Tepezza in real-world scenarios are over sixfold compared to what the manufacturer had reported. Furthermore, many of these auditory issues remain even after ceasing treatment.

In March 2021, the Journal of the Endocrine Society published a significant study. This research highlighted a much higher rate of auditory complications in patients who underwent Tepezza treatment than what Horizon Pharmaceuticals had projected during their FDA approval submission.

The study specifically showed that 65% of patients treated with Tepezza exhibited signs of auditory impairment or tinnitus. This rate is six times higher than original estimates presented by Horizon in the FDA review process.

Contrary to the manufacturers’ claims that hearing impairment would resolve, individuals have now been left with permanent hearing loss after receiving Tepezza infusions. This has resulted in a growing number of Tepezza hearing loss lawsuits being filed, each raising allegations that the manufacturer knew about the risk of permanent hearing loss side effects during clinical trials, and was also aware of the hundreds of hearing-related injuries submitted through the FDA Adverse Event Reporting System (FAERS) by Tepezza users following treatments.

Hearing Loss Complaints Reported to The FDA

According to the FDA’s FAERS database, the number of adverse reactions reported since Tepezza was released have climbed annually, reaching a total of 2,192 adverse events as of June 30, 2023, with 347 reported so far in 2023.

The number of Tepezza complaints reported per year are as follows;

• 2020 Adverse Events: 431
• 2021 Adverse Events: 686
• 2022 Adverse Events: 728

Of the adverse events and side effects reported, many of them have involved hearing complaints, reinforcing plaintiffs’ claims that the manufacturer should have acted quicker in issuing a drug label update.

Some of the most common Tepezza hearing related adverse events reported to the FDA have included:

• Hypoacusis
• Tinnitus
• Deafness
• Autophony
• Eustachian tube dysfunction

In many of the Tepezza lawsuits filed to date, plaintiffs outline a long list of hearing complaints reported to Horizon Therapeutics and the FDA during the months after the drug was introduced in 2020, and started to be used by patients outside of a clinical setting:

• May 13, 2020 – FDA received a report of a consumer experiencing tinnitus following use of Tepezza;
• June 2, 2020 – Horizon notified the FDA of a consumer reporting experiencing tinnitus following use of Tepezza;
• June 4, 2020 – Horizon notified the FDA of a consumer reporting experiencing hypoacusis following use of Tepezza;
• June 8, 2020 – Horizon notified FDA of a report from a healthcare professional of a patient experiencing tinnitus following use of Tepezza;
• June 15, 2020 – Horizon notified FDA of a report from a healthcare professional of a patient experiencing tinnitus following use of Tepezza;
• July 1, 2020 – Horizon notified the FDA of a report from a healthcare professional of a patient experiencing tinnitus and hypoacusis following
  use of Tepezza;
• July 14, 2020 – Horizon notified the FDA of a report from a healthcare professional of a patient experiencing deafness following use of Tepezza;
• July 28, 2020 – Horizon notified the FDA of a report from a healthcare professional of a patient experiencing tinnitus following use of Tepezza;
• August 6, 2020 – Horizon notified the FDA of a report from a healthcare professional of a patient experiencing hypoacusis following use of Tepezza;
• August 14, 2020 – Horizon notified the FDA of a report from a patient experiencing hypoacusis following use of Tepezza;
• August 20, 2020, Horizon notified the FDA of a report from a healthcare professional of a patient experiencing bilateral deafness following use of Tepezza;
• September 1, 2020 – Horizon notified the FDA of a report from a healthcare professional of a patient experiencing tinnitus following use of Tepezza;
• September 7, 2020 – Horizon notified the FDA of a report from a healthcare professional of a patient experiencing hypoacusis following use of Tepezza;
• September 8, 2020 – Horizon notified the FDA of two separate reports—one from a consumer and one from a healthcare professional—of patients experiencing hypoacusis following use of Tepezza;
• September 9, 2020 – Horizon notified the FDA of a report from a healthcare professional of a patient experiencing deafness following use of Tepezza;
• September 10, 2020 – Horizon notified the FDA of a report from a consumer of experiencing hypoacusis following use of Tepezza;
• September 11, 2020 – Horizon notified the FDA of a report from a consumer of experiencing hypoacusis following use of Tepezza;
• September 15, 2020 – Horizon notified the FDA of a report from a healthcare professional of a patient experiencing hypoacusis following use of Tepezza;
• September 18, 2020 – Horizon notified the FDA of a report from a consumer of experiencing hypoacusis and tinnitus following use of Tepezza;
• September 18, 2020 – Horizon notified the FDA of a report from a healthcare professional of a patient experiencing deafness following use of Tepezza;
• September 25, 2020 – Horizon notified the FDA of a report from a healthcare professional of a patient experiencing hypoacusis following use of Tepezza;
• September 28, 2020 – Horizon notified the FDA of a report from a healthcare professional of a patient experiencing hypoacusis following use of Tepezza;
• September 30, 2020 – Horizon notified the FDA of a report from a healthcare professional of a patient experiencing deafness following use of Tepezza;
• September 30, 2020 – Horizon notified the FDA of a report from a consumer of experiencing hypoacusis and tinnitus following use of Tepezza;
• October 9, 2020 – Horizon notified the FDA of a report from a consumer of experiencing deafness following use of Tepezza;
• October 16, 2020 – Horizon notified the FDA of a report from a healthcare professional of a patient experiencing hypoacusis following use of Tepezza;
• October 21, 2020 – the FDA received a report of a consumer experiencing deafness following use of Tepezza;
• October 27, 2020 – Horizon notified the FDA of two separate reports from consumers of experiencing deafness following use of Tepezza;
• November 2, 2020 – Horizon notified the FDA of a report from a consumer of experiencing tinnitus following use of Tepezza;
• November 10, 2020 – Horizon notified the FDA of a report from a consumer of experiencing hypoacusis following use of Tepezza;
• November 16, 2020 – Horizon notified the FDA of a report from a healthcare professional of a patient experiencing deafness following use of Tepezza;
• November 19, 2020 – Horizon notified the FDA of a report from a consumer of experiencing dysacusis and tinnitus following use of Tepezza;
• December 4, 2020 – Horizon notified the FDA of a report from a consumer of experiencing tinnitus following use of Tepezza;
• December 17, 2020 – Horizon notified the FDA of a report from a consumer of experiencing hypoacusis following use of Tepezza;
• December 28, 2020 – Horizon notified the FDA of a report from a healthcare professional of a patient experiencing deafness following use of Tepezza; and
• December 30, 2020, Horizon notified the FDA of a report from a healthcare professional of a patient experiencing hypoacusis following use of Tepezza.

Rather than updating the warning label immediately, lawsuits indicate that Horizon continued to provide false and misleading information to users and the doctors, and information about these problems was not added until nearly three years later.

Tepezza Warning Label Updated As Lawsuits Mount

On July 20, 2023, the FDA released an updated prescribing guideline for Tepezza. This new version mirrors the wording that legal claims suggest should have been part of the original Tepezza label. The updated advisory explicitly states that Tepezza’s side effects could lead to significant hearing damage, which, in certain cases, may be irreversible.

Furthermore, the new directive underscores the need for healthcare professionals to evaluate a patient’s hearing through a thorough auditory assessment before starting the treatment, closely monitor hearing during the therapy, and re-evaluate any auditory complications after the Tepezza treatment has concluded.

This precautionary strategy seeks to detect and address any potential hearing-related issues promptly, especially since many patients undergo multiple Tepezza treatments.

Tepezza Multidistrict Litigation

The updated warning was released as the manufacturer currently faces dozens of Tepezza hearing loss lawsuits, with potentially hundreds or thousands more expected.

Given common questions of fact and law raised in complaints filed in federal courts nationwide, a Tepezza MDL (multidistrict litigation) was established, centralizing the lawsuits before U.S. District Judge Thomas Durkin in the Northern District of Illinois for coordinated discovery and pretrial proceedings.

As part of the litigation, it is expected that a “bellwether” program will be established, where a small group of representative cases will be selected to go through case-specific discovery in preparation for early trial dates, which will help the parties gauge how juries are likely to respond to certain evidence and testimony that will be repeated throughout various cases in the litigation.

Following coordinated discovery and trials in the MDL, if the parties fail to reach a Tepezza settlement agreement or other resolution for the litigation, each individual claim may later be remanded back to the U.S. District Court where it was originally filed for trial.

Have a Tepezza Lawyer Review Your Hearing Loss Case

If you or a loved one received any number of Tepezza infusion and have complaints involving hearing loss side effects, compensation may be available through a Tepezza lawsuit.

Lawyers across the nation are reviewing claims for individuals on a contingency fee basis, meaning there are never any expenses or fees unless a settlement is obtained. Submit information to have a lawyer review your potential case to see if you qualify after experiencing any of the following side effects from Tepezza, including;

• Permanent hearing loss
• Partial hearing loss
• Tinnitus (ringing of the ears)
• Sensorineural hearing loss
• Ear plugging sensation
• Autophony
• Deafness
• Other hearing side effects