Tumor necrosis factor-alpha blockers, otherwise known as TNFα inhibitors, are used to treat a variety of autoimmune disorders including: Crohn’s disease, ulcerative colitis, rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, plaque psoriasis, and juvenile idiopathic arthritis. Unfortunately, TNFα treatment has become the subject of intense scrutiny in the healthcare community. Because the pharmacodynamics of TNFα blockers suppress the immune system, they may significantly increase the risk of developing severe, life-threatening opportunistic infections. rare forms of aggressive cancer, and extensive nerve damage.
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If you or a loved one has been injured by a TNFα blocker, you should contact our lawyers immediately for a free confidential case evaluation. You may be entitled to compensation for your injuries and we can help.
What’s the problem?
TNFα blockers are biologic products that include name brands such as Remicade (infliximab), Enbrel (etanercept), Humira (adalimumab), Cimzia (certolizumab pegol), and Simponi (golimumab). Each of which have the inherent ability to treat Crohn’s disease, ulcerative colitis, rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, plaque psoriasis, and/or juvenile idiopathic arthritis.
TNFα blockers are specifically designed to neutralize tumor necrosis factor-alpha, a protein with the inherent ability to promote inflammation in the presence of inflammatory diseases. Subsequently, TNFα blockers bind to tumor necrosis factor-alpha, preventing it from activating receptors. Doing so has proven to be beneficial in suppressing inflammatory reactions associated with autoimmune diseases.
Unfortunately, an influx of adverse events related to the use of TNFα blockers has created a cause for concern in the healthcare community. Recent studies suggest that treatment with a TNFα blocker may be responsible for catastrophic complications. Patients who utilize TNFα blockers to treat autoimmune diseases, may significantly increase their risk of developing severe, life-threatening infections. Because TNFα blockers suppress the immune system, prolonged treatment may significantly increase the risk of infection from two bacterial pathogens known as Legionella and Listeria. Recent evidence suggests that these medicines may also be responsible for the development of a rare form of cancer. Due to the severity of infections associated with TNFα blockers, patients may contact a lawyer at The Senators (Ret.) Firm, LLP for a free case evaluation of their potential Tumor necrosis factor-alpha blocker lawsuit.
TNFα Label Change
The following FDA warning is to inform the healthcare community that TNFα inhibitors may weaken the immune system and make it susceptible to dangerous infections:
The U.S. Food and Drug Administration (FDA) is informing healthcare professionals that the Boxed Warning for the entire class of Tumor Necrosis Factor-alpha (TNFα) blockers has been updated to include the risk of infection from two bacterial pathogens, Legionella and Listeria. In addition, the Boxed Warning and Warnings and Precautions sections of the labels for all of the TNFα blockers have been revised so that they contain consistent information about the risk for serious infections and the associated disease-causing pathogens.
FDA Safety Communication
The following FDA Safety Communication acknowledges the dangers associated with TNFα treatment:
Serious, including fatal, infections are a known risk of TNFα blockers. These infections can involve various organ systems and sites due to bacterial, mycobacterial (e.g., tuberculosis), fungal (e.g., histoplasmosis, aspergillosis, candidiasis, coccidioidomycosis, blastomycosis, pneumocystosis), viral (e.g., hepatitis B), and other opportunistic pathogens (organisms that usually do not cause disease in healthy people, but can cause serious illness when a person’s immune system (resistance) has weakened).
Recently, FDA reviewed cases of infection in patients treated with TNFα blockers. The addition of Legionella and Listeria to the drug labels of the TNFα blockers will provide healthcare professionals with more information about opportunistic pathogens that can cause serious infections in patients treated with TNFα blockers.
Adverse Event Reports
The FDA has recently been made aware of a number of cases of Legionella pneumonia in patients treated with TNFα blockers. After conducting a search of their Adverse Event Reporting System (AERS) database, the FDA discovered a total of 80 patients who were diagnosed with Legionella pneumonia after having received TNFα blockers between 1999 and 2010. Sixty-five percent of the cases that involved TNFα blocker administration dealt with rheumatoid arthritis. The median duration of TNFα blocker administration prior to onset of Legionella pneumonia was 10.4 months (range <1 to 73 months). Of the 80 cases, reports for 30 patients provided information regarding laboratory confirmation of Legionella infection. Many of the patients received methotrexate, corticosteroids, or both drugs, concomitantly. According to the reports, there were 14 deaths in the case series investigated by the FDA.
Scientific literature reviewed by the FDA acknowledged 23 patients who developed Legionella pneumonia after being treated with TNFα blockers for rheumatologic disorders, inflammatory bowel disease, and psoriasis. The published English-literature revealed that patients were between the ages of 26 and 71 years of age. TNFα blockers included in the scientific literature were infliximab, adalimumab, and etanercept. Twenty-two of the patients received concomitant immunosuppressive drugs to assist in the process of treatment. Four patients experienced severe pneumonia requiring mechanical ventilation, and five patients received treatment in a hospital intensive care unit. Unfortunately, three of the infections proved to be fatal, while one developed a reoccurrence of Legionella pneumonia following re-initiation of a TNFα blocker.
The U.S. Food and Drug Administration has also received numerous reports of serious Listeria monocytogenes infections in patients undergoing TNFα blocker treatment. A review of scientific literature acknowledged 26 situations associating Listeria infection to TNFα blocker-treated patients. Infections included meningitis, bacteremia, endophthalmitis, and sepsis. Unfortunately, these infections resulted in seven fatalities. Furthermore, the FDA identified fatal Listeria infections in a review of data regarding laboratory-confirmed infections that occurred in pre-marketing phase 2 and phase 3 clinical trials and from post-marketing surveillance.
TNFα Blocker Cancer Risk
Recent studies suggests that adults, and particularly children, who receive TNFα blocker treatment may significantly increase their risk of developing a rare type of cancer that attacks white blood cells. According to an FDA Safety Communication, some people have developed hepatosplenic T-cell lymphoma, following TNFα blocker treatment. There is currently no cure for this aggressive cancer that often leads to fatal circumstances.
Those who use TNFα blockers may also increase their risk of developing two types of skin cancer (basal cell and squamous cell). While these types are generally not life-threatening, neglecting treatment may result in catastrophic complications.
Do I Have a TNFα blocker Lawsuit?
The trial lawyers at The Senators (Ret.) Firm, LLP have decades of experience navigating through complex legislative and regulatory issues and litigating high stakes cases all over the nation. Our law firm focuses on the representation of plaintiffs in TNFα blocker lawsuits. We are currently accepting new cases in all 50 states.
Again, if you or a loved one has been injured by a TNFα blocker, you should contact our lawyers immediately by clicking the link below or calling toll free 1-(949) 557-5800. You may be entitled to compensation for your injuries and we can help.