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FDA Drug Safety Podcast for Healthcare Professionals: Drug labels for the Tumor Necrosis Factor-alpha (TNFα) blockers now include warnings about infection with Legionella and Listeria bacteria

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Welcome, my name is Steve Jackson, a pharmacist in the Division of Drug Information.  On September 7, 2011, the Food and Drug Administration issued a Drug Safety Communication informing healthcare professionals that the Boxed Warning for the entire class of Tumor Necrosis Factor-alpha, or 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. 

Serious, including fatal, infections are a known risk of TNFα blockers. These infections can involve various organ systems and sites due to bacterial, mycobacterial (such as tuberculosis), fungal (such as histoplasmosis, aspergillosis, candidiasis, coccidioidomycosis, blastomycosis, pneumocystosis), viral (such as hepatitis B), and other opportunistic pathogens. 

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. 

It is important for healthcare professionals to be aware of the new labeling changes. 

At this time, FDA recommends that Healthcare Professionals be aware that:

  1. Patients treated with TNFα blockers are at increased risk for developing serious infections involving multiple organ systems and sites that may lead to hospitalization or death due to bacterial, mycobacterial, fungal, viral, parasitic, and other opportunistic pathogens.
  2. The bacterial pathogens Legionella and Listeria have been added to the Boxed Warning for the entire class of TNFα blockers.
  3. The risks and the benefits of TNFα blockers should be considered prior to initiating therapy in patients with chronic or recurrent infection and patients with underlying conditions that may predispose them to infection.
  4. Patients greater than 65 years old and patients taking concomitant immunosuppressants may be at greater risk of infection.
  5. Prior to initiating TNFα blockers and periodically during treatment, patients should be evaluated for active tuberculosis and tested for latent infection.
  6. Patients should be monitored for signs and symptoms of serious infections while taking TNFα blockers.
  7. Empiric antifungal therapy should be considered in patients at risk for invasive fungal infections who develop severe systemic illness.
  8. Healthcare professionals should encourage patients to read the Medication Guide that accompanies their prescription for a TNFα blocker.
  9. Healthcare professionals should report adverse events involving TNFα blockers to the FDA MedWatch program at www.fda.gov/medwatch.

Thank you for listening. The FDA is committed to keeping healthcare professionals informed of the latest safety information.  Please read the Drug Safety Communication for the complete Data Summary detailing this communication.  A link to this DSC can be found at www.fda.gov/Drugs/DrugSafety.   If you have drug questions, you can reach us at druginfo@fda.hhs.gov.


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