In the realm of modern medicine, biologic therapies have revolutionized treatment approaches for a myriad of conditions, offering new hope and efficacy for patients worldwide.

However, alongside their benefits, these novel therapies often come with complex side effects that can pose significant challenges for both patients and healthcare providers.

Recent lawsuits involving biologic therapies have shed light on these side effect profiles. They have prompted a critical examination of their implications for patient care and drug regulation.

Understanding Biologic Therapies

Biologic therapies are a class of medications derived from living organisms or their components, such as proteins, cells, or DNA. These drugs, as explained by, are synthetic proteins engineered to target specific components of the immune system responsible for triggering inflammation. They address a variety of conditions including cancer, psoriasis, and inflammatory bowel diseases.

They are designed to offer specialized treatment options for patients dealing with diverse and often complex health challenges.  Typically administered via injection or intravenous infusion, biologics offer a targeted approach to therapy, modulating immune responses to alleviate symptoms and improve patient outcomes.

The Promise and Complexity of Biologic Therapies

Biologic therapies have transformed the treatment landscape by offering targeted approaches with potentially fewer side effects compared to traditional medications.

Their ability to precisely intervene in disease pathways has led to significant improvements in patient outcomes and quality of life. However, the intricate nature of biologics also introduces complexities, particularly concerning their side effect profiles.

Side Effects of Biologic Therapies

Biologic therapies, while offering promising outcomes, can elicit a spectrum of adverse reactions, ranging from mild to severe. Commonly reported side effects encompass injection site reactions, flu-like symptoms, and gastrointestinal disturbances. Nonetheless, more severe adverse events, including allergic reactions, infections, and immune-related disorders, may also manifest.  

According to WebMD, the likelihood of experiencing side effects depends on factors like the specific biologic drug used and the duration of usage. Individual medical history and response to treatment also play significant roles in determining the occurrence of side effects.  

In a study of 1,000 individuals on biologic medication and 1,000 on a placebo, 770 in the biologic group reported side effects. This was slightly higher than the 724 individuals who reported side effects in the placebo group.

Additionally, 127 individuals in the biologic group reported serious side effects compared to 118 in the placebo group.

Perspectives from Recent Lawsuits

Recent lawsuits surrounding biologic therapies have brought attention to potential risks associated with these treatments. One notable instance is the Tepezza lawsuit, which centers on Tepezza, a biologic medication used for treating thyroid eye disease.

Tepezza has faced scrutiny due to allegations linking it to permanent hearing loss. This issue was highlighted in a recent study published in the medical journal Endocrine Practice. The study found that 16% of patients experienced adverse events related to hearing after receiving Tepezza. These adverse events included symptoms such as tinnitus, hearing impairment, and eustachian tube dysfunction.

These findings have prompted legal actions against the manufacturer, Horizon Therapeutics. As of May 2024, there were 113 pending cases related to Tepezza in the MDL (multidistrict litigation) process, Drugwatch reports.

As per TorHoerman Law, plaintiffs in these lawsuits assert that they were not adequately warned about the potential risks associated with Tepezza. This lack of warning has led to unexpected and severe health complications.

Implications for Patient Care

The emergence of lawsuits related to biologic therapies underscores the importance of thorough risk assessment and informed decision-making in clinical practice. Healthcare providers must carefully evaluate the benefits and risks of these treatments, taking into account individual patient factors and preferences.

Transparent communication with patients regarding potential side effects is essential to ensure shared decision-making and mitigate adverse outcomes.

Challenges in Drug Regulation

The occurrence of side effects linked to biologic therapies raises significant questions about the adequacy of existing drug regulation procedures. For instance, evidence of permanent hearing loss associated with Tepezza dates back to its clinical trials. Despite this, the FDA's delay in adding a warning for this side effect suggests potential gaps in the regulatory process.

Had the FDA taken a more proactive approach in issuing warnings earlier, the situation surrounding Tepezza might have been preventable.

However, post-market surveillance mechanisms must also be robust to detect and address emerging safety concerns promptly. Such measures are essential to ensuring the ongoing safety and effectiveness of biologic therapies for patients.


What are biologic therapies?

Biologic therapies encompass medications sourced from living organisms or their constituents, including proteins, cells, or DNA. They are designed to target specific pathways in the body's immune system or other biological processes to treat various diseases.

What is Tepezza?

Tepezza is a biologic medication approved by the FDA for the treatment of thyroid eye disease (TED). It works by targeting the underlying autoimmune mechanisms associated with TED, reducing inflammation and improving symptoms such as eye bulging and double vision.

What are Tepezza Lawsuits?

Tepezza lawsuits are legal actions filed against Tepezza's manufacturer. They allege that the medication has caused severe side effects, particularly permanent hearing loss, in some patients. These legal actions assert that the manufacturer did not sufficiently inform patients and healthcare providers about these risks.

In conclusion, as the field of biologic therapies continues to advance, it is essential to prioritize patient safety and enhance transparency regarding potential risks. Healthcare providers, pharmaceutical companies, and regulatory agencies must collaborate to promote vigilant monitoring of side effects and facilitate informed patient consent.

They also need to ensure timely intervention in cases of adverse events. By learning from recent lawsuits and incorporating lessons into clinical practice, we can maximize the benefits of biologic therapies while minimizing risks for patients worldwide.