When it first appeared on the pharmaceutical market, Tepezza (having teprotumumab as its active ingredient) was received with anticipation by both doctors and patients.
Having been the first and sole prescription drug approved by the U.S. Food and Drug Administration for the treatment of thyroid eye disease (TED), it promised long-awaited relief to TED patients all over the nation.
Soon enough, though, studies that followed the FDA approval raised serious concerns about the safety of the drug and revealed a scary link between Tepezza usage and hearing loss (partial or permanent). These studies did not question the drug's efficacity in treating TED but drew attention to the high probability of developing health-endangering conditions as side effects of Tepezza.
Tepezza was approved by the FDA in January 2020 with orphan drug designation. The concept behind the orphan drug designation applied by the FDA for some drugs is to encourage drug manufacturers to invest time, energy, and resources into developing treatments for rare diseases (also known as orphan diseases).
Orphan drug designation permits a fast-track approval process for the drug's manufacturer, and it also involves far less extensive pre-approval testing than a standard approval process would. Manufacturers may benefit from appealing incentives, such as:
These incentives aim to ensure that treatment possibilities for rare diseases are sought after and actively pursued and that the number of drugs available to treat rare diseases increases.
Orphan drug designation, however, grants no exemption from rigorous testing even after approval, nor from the accurate and proper information of the public with regard to all possible side effects and occurrence risk rates.
In the Tepezza Prescribing Information issued by Horizon Pharmaceuticals, the manufacturer of Tepezza warned about possible adverse effects of the drug, listing hearing impairment too (further detailed as including deafness, eustachian tube dysfunction, hyperacusis, hypoacusis, and autophony), giving it a possible occurrence rate of 10%. Hearing-related health risks associated with the use of the drug were warned by Horizon to be mild and reversible.
Several studies conducted after the drug was already approved and prescribed as a treatment for TED have later drawn attention to the fact that hearing impairment risks are more than six times higher than the estimated 10%, reaching 65% or more. An alarming conclusion of these studies was the fact that hearing loss, tinnitus, or other auditory adverse effects are not reversible in each case and that treatment with Tepezza carries the risk of permanent hearing impairment.
In January 2021, a small study conducted by a group of researchers at Stanford University and presented virtually at ENDO 2021 (the annual meeting of the Endocrine Society) found that 65% of the patients participating in the study developed hearing loss, tinnitus or other hearing impairment. Furthermore, some of these adverse effects were found to remain permanent, persisting even after the Tepezza treatment was long concluded.
In February 2022, another study published in the American Journal of Ophthalmology raised more alarming question marks regarding the safety of Tepezza, as its findings concluded that the risk of developing otologic symptoms can reach as high of a percentage as 81.5%. This study also revealed that in some patients, hearing-related health damages proved to be irreversible.
Opting for any treatment of a rare disease is a big decision, and it should always be an informed one, where both doctors prescribing the drug and patients using it are fully aware of any significant health risks involved. Unfortunately, because Horizon Pharmaceuticals failed to properly and accurately warn about the hearing loss risks involved, neither doctors nor Tepezza patients were given the option to take an informed decision. Patients who suffered permanent hearing loss or tinnitus following their Tepezza treatment may be entitled to compensation, and as a result, Tepezza claims that hold Horizon Pharmaceutical accountable for inadequate product marketing are currently filed nationwide.
Generally speaking, if you have no hearing history prior to your Tepezza infusion treatment and have an established diagnosis of hearing loss after treatment with Tepezza, you fulfill the two main requirements for participating in a Tepezza claim.
Your quest for rightful compensation from the manufacturer of the Tepezza drug starts with determining your eligibility in a Tepezza claim.
Our team at Atraxia Law can help you understand every detail involved with a Tepezza claim and is able to determine whether or not you qualify. We will carefully go over the details of your case and will thoroughly analyze your chances for compensation.