The Tepezza Controversy: Understanding the Lawsuit Surrounding the New Drug
Tepezza is a new drug that was approved by the US Food and Drug Administration (FDA) in 2020 for the treatment of Thyroid Eye Disease (TED), an autoimmune condition that affects the eyes. The drug works by blocking the activity of a protein called TSHR, which is thought to be involved in the development of TED.
Following its approval, Tepezza generated significant excitement as a potential breakthrough treatment for TED, as there were previously limited options for treating the disease. However, soon after its approval, controversy began to emerge surrounding the drug’s safety and effectiveness.
Several lawsuits were filed against the manufacturer of Tepezza, alleging that the drug was not safe and effective as claimed and that the FDA approved it based on flawed clinical trials. Some of the lawsuits specifically alleged that the drug caused serious side effects, including hearing loss, a sensation that their ears were plugged, autophony, and tinnitus.
The lawsuit also claimed that permanent hearing damage associated with the drug could have been avoided if the manufacturer had adequately warned about these potential risks.
The Lawsuit
The Tepezza lawsuit refers to a legal action brought against the makers of Tepezza. The lawsuit specifically alleges that the drug caused hearing loss in some patients and that the manufacturer failed to adequately warn about this potential side effect.
The plaintiffs, in this case, claim they suffered from hearing loss after taking Tepezza and that their doctors did not properly warn them about it before prescribing it as part of their treatment plan. They are seeking compensation for their injuries and damages, as well as changes to labeling requirements so consumers know what risks they may face if taking this medication
Evidence
According to Drugwatch, a research of 26 people who were treated with Tapezza showed 23% suffering from hearing loss. The patient’s hearing loss was either new or worse because of the drug.
In some patients, the symptoms did go away after stopping the drug. However, for many, it continued even after stopping treatment.
The same study also showed 27% of people suffer from tinnitus (ringing in the ears). In this case, also, some patients reported the symptoms to be resolved after a few months.
The researchers were not sure if symptoms could be reversed in people whose tinnitus continued after treatment stopped.
Patient Perspective
From the patients’ perspective, the lawsuit is an opportunity to hold the manufacturer of Tepezza accountable for any harm caused by the drug and to seek compensation for their injuries.
According to Becker’s ASC Review, a plaintiff, Mr. Weibel, has claimed that Tepezza manufacturers received FDA approval only because they did not disclose their hearing-related side effects data of the drug.
Horizon has earned a revenue of USD 1.66 billion from the drug in 2021. The plaintiff alleged that the drug manufacturer warns of hearing loss in 10% of patients, but only 100 people were studied in their clinical trials.
It is also claimed that in the lawsuit the manufacturer told the patients that the loss of hearing was temporary which it was not.
Future Implications
The outcome of the Tepezza lawsuit will have important implications for the future of the drug, as well as for the pharmaceutical industry more broadly. Here are some possible future implications of the lawsuit:
- Impact on Tepezza’s market status: The outcome of the Tepezza lawsuit will have a significant impact on the drug’s market status, including its sales and prescribing patterns.
If the lawsuit results in a settlement or a judgment against the manufacturer, it may discourage doctors from prescribing the drug, leading to a decrease in its sales. On the other hand, if the manufacturer successfully defends the drug’s safety and efficacy, it may continue to be widely prescribed to patients with TED.
- Implications for patient safety: The Tepezza lawsuit is likely to raise important questions about patient safety and the regulatory process for new drugs. If the lawsuit results in a settlement or a judgment against the manufacturer, it may lead to increased scrutiny of the FDA’s approval process and the safety of other new drugs.
On the other hand, if the manufacturer successfully defends the drug’s safety, it may reinforce the FDA’s current regulatory framework and patients’ confidence in new treatments.
- Impact on the pharmaceutical industry: The Tepezza lawsuit may also have broader implications for the pharmaceutical industry, including the development of new drugs and the relationship between the industry and the regulatory agencies.
If the lawsuit results in a settlement or a judgment against the manufacturer, it may lead to increased regulations on the pharmaceutical industry and a decrease in investment in the development of new drugs.
On the other hand, if the manufacturer successfully defends the drug’s safety and efficacy, it may reinforce the current system for developing and approving new drugs.
Conclusion
The Tepezza controversy is a complex issue that raises many questions about the safety and efficacy of new drugs. The lawsuit was brought by patients who felt they were harmed by the drug, but it also raises questions about how we should regulate new treatments to protect consumers while still allowing innovation in medicine.
It will be interesting to see how this case is resolved and what kind of impact it may have on future drug approvals or development processes.
