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While all immunosuppressant drugs carry an inherent risk of infection, the FDA recently warned that drugs belonging to the class of Tumor Necrosis Factor-alpha (TNFα or TNF) blockers place patients at a higher risk of contracting Legionella and Listeria pathogens, which may cause potentially fatal illnesses like sepsis, pneumonia or meningitis.

TNF Blockers: An Overview

The class of drugs known as Tumor Necrosis Factor-alpha (TNFα or TNF) blockers are used to treat autoimmune conditions that cause a constant inflammation in the body.

In people suffering from autoimmune disorders, the body cannot tell the difference between natural tissue and foreign body substances. Because of this confusion, the body initiates an overreactive immune response, which leads to chronic inflammation of parts of the body and conditions like Crohn’s disease, ulcerative colitis, rheumatoid arthritis, ankylosing spondylitis, plaque psoriasis and juvenile idiopathic arthritis.

TNF blockers are immunosuppressants, meaning they try to inhibit the functions of the immune system, in order to normalize it and prevent it from overactive response and chronic inflammation.

Unfortunately, immunosuppressants also carry an inherent risk. Because they reduce the activity of the immune system, there’s always the potential that they also reduce the body’s ability to fight infections, leaving the body susceptible to infections involving various organ systems and sites. The infections may be bacterial, mycobacterial, fungal, histoplasmosis, aspergillosis, candidiasis, coccidioidomycosis, blastomycosis, pneumocystosis, viral or caused by other opportunistic pathogens.

On September 7, 2011, the FDA announced it was updating warning labels on TNF blockers to include the risk of infection from two bacterial pathogens, Legionella and Listeria, which could cause life-threatening and fatal illnesses including pneumonia, meningitis and sepsis.

Due to the severity of the Legionella and Listeria infections caused by TNF blockers, you or someone you know who took TNF blockers and contracted an illness associated with Legionella or Listeria may want to contact an TNF blockers lawyer or attorney with The Clark Firm to discuss the potential for a TNF blockers lawsuit.

Side Effects of TNF Blockers

TNF Blockers have been linked to Legionella and Listeria pathogens. When people contract these bacteria, it may lead to illnesses like:

  • Flu-like symptoms
  • Pneumonia
  • Bacteremia
  • Endophthalmitis
  • Sepsis
  • Meningitis

FDA Warning

The FDA has identified 80 cases of Legionella pneumonia in patients treated with TNF blockers between 1999 and 2010. Of the 80 reports, there were 14 deaths. The median age of patients was 56 years old (range 25 to 85 years). Most frequently, the patients were receiving TNF blockers for rheumatoid arthritis.

Additionally, a search of the English-language medical literature identified published case reports of 23 additional patients who developed Legionella pneumonia after TNF blocker treatment for rheumatologic disorders, inflammatory bowel disease or psoriasis. Four of these patients experienced pneumonia severe enough that it required mechanical ventilation with a breathing machine and five patients received treatment in a hospital ICU. Three of the 23 patients died. Notably, one patient developed a second episode of Legionella pneumonia after restarting TNF blocker therapy.

The FDA has also received reports of serious infections due to Listeria monocytogenes in patients taking TNF blockers. After reviewing the medical literature, the FDA identified 26 cases of Listeria infection in TNF blocker-treated patients. The infections led to meningitis, bacteremia, endophthalmitis and sepsis. Seven of these 26 patients died.

In all sets of data, the majority of patients were taking other immunosuppressive drugs simultaneously with TNF blockers.

Said the FDA about the infection risk:

“The pathogens Legionella and Listeria have been added to the Boxed Warning for the entire class of TNFα blockers, so that healthcare professionals are aware that these pathogens can cause serious and potentially fatal outcomes in patients treated with TNFα blockers.”

What is Legionella?

Legionella is a bacteria that was discovered in 1976. Most commonly transmitted through the inhalation of mist droplets, Legionella may be found in cooling towers, swimming pools, fountains, ponds and creeks. Initial symptoms of a Legionella infection are flu-like, including fever, chill and cough. Legionella is particularly dangerous if it advances into pneumonia, which is an infection of the lungs.

While Legionella is not normally a threat to most healthy people, it can be potentially dangerous to patients with weakened immune systems as a result of TNF blocker therapy.

What is Listeria?

Listeria is a rare infection that usually infects people who have eaten food contaminated with the bacteria. Listeria can cause manifestations of sepsis and meningitis, which are both severe and life-threatening illnesses. Sepsis occurs when the entire body is overcome with bacteria, leading to a whole-body inflammatory state. Meningitis is a bacteria infection of the brain. Listeria has a mortality rate of 25 percent.

Like Legionella, Listeria is a rare infection that normally would not harm healthy individuals. However, people who have been taking TNF blockers and may have a weakened immune system may be at risk.

Drugs in the TNFα Blockers Class

The following drugs are TNFα blockers:

  • Remicade (infliximab)
  • Enbrel (etanercept)
  • Humira (adalimumab)
  • Cimzia (certolizumab pegol)
  • Simponi (golimumab)

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