You come home from a hard day at work and notice a slight protrusion in your eyes. Within months, an alarming transformation occurs. Your eyes begin bulging out at an angle, the skin behind them appearing swollen and inflamed. Squinting brings dull headaches, your vision is blurred and simple tasks like listening to music are getting difficult.
Your doctor diagnoses you with thyroid eye disease. As they explain treatment options, you feel a wave of desperation. There are no FDA-approved drugs to stop the autoimmune attack on your optic nerves.
But then they mention a newly approved medication called Tepezza. Could this drug rescue your vision when nothing else could? In this blog post, we will shed light on the efficacy of Tepezza, the recent developments around its severe side effects, and the balanced path ahead.
What Tepezza Offers
Tepezza is the first FDA-approved medication for treating thyroid eye disease, a rare autoimmune ailment. In severe cases, optic nerve compression can cause permanent vision loss. Tepezza promised a game-changing medication, administered intravenous, once every 3 weeks, for a total of 8 shots.
Clinical trials by manufacturer Horizon Therapeutics claimed extraordinary results in a majority of thyroid patients. Results described “improved quality of life” through less eye bulging, reduced eye pain and light sensitivity, stabilized vision
Based on these promising results, the manufacturer petitioned the FDA for accelerated approval in early 2020 while pursuing additional larger confirmatory studies. This approval pathway helps patients gain expedited access to therapies showing the impact on serious conditions lacking treatments.
It marked hope for thousands living with rapidly deteriorating vision.
The Emergence of Side Effects
In the beginning, doctors remained unaware of the risks accompanying Tepezza’s benefits. With accelerated approval based on limited trials, the full scope of side effects had yet to emerge.
However, complaints of adverse reactions escalated quickly. Weeks into treatment cycles, patients sounded alarms about sudden, painful pressure behind the ears and increased sensitivity to sound.
The National Library of Medicine conducted research including 131 patients. Adverse events were reported in over 80% of patients. According to TorHoerman Law, some potential adverse effects of Tepezza include hair loss, inflammatory bowel disease getting worse, change in taste perception, and diarrhea, to name a few.
Horizon maintained confidence in Tepezza’s overall “favorable benefit-risk profile” for thyroid patients. But with no root cause identified, the painful consequences have left patients questioning if shortcuts in the hurried approval process have put them at risk.
Patients Take Legal Action
A recent research study published by the Endocrine Society revealed that as many as 65% of patients reported experiencing hearing loss or other related auditory issues following treatment with Tepezza.
If you or a loved one took Tepezza and experienced tinnitus or other severe hearing issues, as a result, you might be qualified to file a Tepezza lawsuit.
Filed complaints allege Horizon knew or should have known about immuno-inflammatory risks based on the drug’s mechanism. By failing to warn patients on labels and through physician guidance, victims allege the manufacturer showed negligence and defective designs.
Claims stemming from issues with Tepezza fall within the realm of product liability law. Unlike other legal avenues, product liability law does not require plaintiffs to prove negligence by the defendant.
Under this legal framework, you, as a plaintiff, have the option to pursue legal action against not only the drug manufacturer but also merchants and other entities involved in distributing the product.
If you can demonstrate that Tepezza caused harm when used as intended or that they were not adequately warned about the product’s risks, they may be entitled to compensation for losses resulting directly from the company’s shortcomings.
The Dilemma of Access vs. Safety
Access advocates argue that despite side effects, you should rely on your physician’s guidance using the only approved treatment for your condition. According to them, weighing the larger positive patient experience is more important instead of panicking over risks affecting a minority.
But critics increasingly question if limiting access, till further tests are done, offers the wiser, more ethical path.
However, public interest groups believe in guidelines limiting Tepezza’s use to specialized physicians until additional monitoring offers prudent safeguards. Lawsuits may also bring to light additional safety data to inform policy decisions.
Path Forward: Achieving Balance
Rather than a simplistic binary choice between access and safety, experts suggest a few potential paths that balance both ethical imperatives.
- Horizon could continue controlled distribution to physicians but implement safety-focused measures. It could use enhanced adverse event monitoring and modify informed consent language to emphasize vision loss risks.
- Lowering Tepezza’s price tag also warrants consideration. Currently, you can get hold of one vial at $14,900 to $16,301.09 in the United States. The treatment is supposed to go on for 8 infusions. Critics argue high costs burden patients and insurers when safer alternatives could emerge.
Federal agencies might collaborate to research cheaper therapies or insurance coverage options easing the dilemma between patient needs and price points.
To conclude, open, constructive dialogue between stakeholders – patients, physicians, manufacturers, and regulators – offers the best hope. You need to remain cautiously optimistic that your physician can mitigate risks if you resume treatment.