FDA Alert: Warning labels for all Tumor Necrosis Factor-alpha (TNFa) blockers will be updated to include information about the risk of bacterial infection from Legionella and Listeria Monocytogenes. Medications receiving the new labeling changes include Remicade, Enbrel, Humira, Cimzia, and Simponi. The Defective Drug lawyers at Schmidt & Clark, LLP are currently investigating potential lawsuits nationwide on behalf of individuals injured by TNFa side effects.
TNF Blocker Update 11/4/11: The FDA is warning healthcare professionals to report cases of malignancy in patients being treated with TNF blockers. The administration has continued to receive reports of a rare cancer of the white blood cells known as Hepatosplenic T-Cell Lymphoma (HSTCL) in adolescents and young adults being treated for Crohn’s disease and ulcerative colitis with TNF blockers. Click here to learn more.
Free Tumor Necrosis Factor-alpha (TNFa) Lawsuit Case Evaluation: If you or a loved one has been injured by a TNFa medication, you should contact our law firm immediately. You may be entitled to compensation by filing a lawsuit and we can help.
What’s the problem?
September 7, 2011 – The U.S. Food & Drug Administration (FDA) issued a press release today notifying the public and healthcare professionals that the Boxed Warning for the entire class of Tumor Necrosis Factor-alpha (TNFa) blockers has been updated to include verbiage concerning the risk of infection from Legionella and Listeria bacterial pathogens. Additionally, the Boxed Warning and Warnings and Precautions sections of the labels have been revised to contain consistent information about the risk for serious infections and the associated bacterial pathogens. TNFa blockers affected by this action include:
- Remicade (infliximab)
- Enbrel (etanercept)
- Humira (adalimumab)
- Cimzia (certolizumab pegol)
- Simponi (golimumab)
Individuals taking TNFa blockers are at an increased risk for developing life-threatening infections involving multiple organ systems due to bacterial, mycobacterial, fungal, viral, parasitic, and other opportunistic pathogens. The FDA is advising doctors and patients to weigh the risks vs. benefits of TNFa blockers prior to undergoing treatment. Please go to the drug safety communication for a comprehensive listing of recommendations for doctors and patients, as well as a data summary.
TNF Blocker Overview
TNF blockers are designed to neutralize a protein called tumor necrosis factor-alpha that causes inflammation when overproduced due to inflammatory diseases. In doing so, TNF blockers suppress the immune system. This class of drugs is designed to treat a wide variety of ailments including (but not limited to):
- Crohn’s disease
- ulcerative colitis
- rheumatoid arthritis
- plaque psoriasis
In 2008, the FDA issued a press release warning about the risk of potentially fatal fungal infections from TNF blockers including histoplasmosis, blastomycosis and coccidioidmycosis. Interestingly, people living in the Mississippi and Ohio River Valleys have been found to be at a heightened risk for these infections, but individuals taking other medications such as immune-suppressants may also be at an increased risk.
Between 1999 and 2010, the FDA received reports of at least 80 people who developed Legionella pneumonia after taking a TNF blocker, most often to treat rheumatoid arthritis. Sadly, the administration reported 14 cases that resulted in death. An FDA search of medical literature turned up at least 26 cases of listeria infection following the use of TNF blockers, which included seven deaths and reports of meningitis, sepsis and other adverse health conditions.
If you are taking TNF Blockers
If you are taking TNF blockers, the FDA is advising you to inform your doctor if you are being treated for an infection or if you have infections that keep coming back. Doctors are warned to watch for signs of infection, cases of recurring infection, and underlying conditions that could make patients particularly prone to bacterial infections. Healthcare professionals are also advised to be aware of opportunistic pathogens that could cause illness and death, particularly in elderly patients.
Listeria infections, also known as listeriosis, pose a significant risk for children, the elderly, and those with otherwise compromised immune systems. In pregnant women, listeriosis infections can lead to miscarriages and stillbirths. Sadly, about a quarter of those individuals who contract listeriosis will end up dying, even if they receive medical treatment. Signs and symptoms of listeriosis include (but are not limited to):
- muscle aches
- abdominal pain
- severe headaches
According to the Centers for Disease Control and Prevention (CDC), Legionnaire’s disease is a potentially fatal bacterial infection that hospitalizes nearly 20,000 people each year (5% – 30% of whom eventually die). It produces symptoms similar to those found with pneumonia, which can include:
- high fever
- muscle aches
Legionalla bacteria is found in warm water, and can be present in hot tubs, cooling towers, hot water tanks and large plumbing or air conditioning systems. A person can be infected by breathing in mist or vapor contaminated with the bacteria, but it cannot be transmitted person to person.
Do You Have a Tumor Necrosis Factor-alpha (TNFa) Blocker Lawsuit?
The Product Liability & Defective Drug Litigation Group at our law firm is an experienced team of trial lawyers that focus on the representation of plaintiffs in TNFa lawsuits. We are handling individual litigation nationwide and currently accepting new TNF injury cases in all 50 states.