Thursday, September 8, 2011

FDA Issues New Alpha TNF Blockers Warning

This news item from the FDA caught my attention yesterday: The FDA has updated the box warnings for alpha TNF inhibitors to include an increased risk of infections from bacterial pathogens - or disease causing organisms -  Legionella and Listeria.

What's an alpha TNF inhibitor? It's a medication that blocks the tumor necrotizing factor found on molecules of the immune system and reduces inflammation and destruction of joints. These drugs are most commonly used in the treatment of Crohn's disease, ulcerative colitis, rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, plaque psoriasis, juvenile idiopathic arthritis, and other autoimmune rheumatic conditions.

Classified with other similar medications as biologics, alpha TNF factor medications include Enbrel (etanercept), Remicade (infliximab), Humira (adalimumab), Simponi (golimumab), and Cimzia (certolizumab pegol). You can read more about biologics including alpha TNF inhibitors here.

These medications suppress the immune system, making users more prone to serious, even fatal infections caused by bacteria, mycobacteria, viruses, fungi, parasites and other opportunistic pathogens - organisms that take advantage of a host's weakened immune system. Practitioners have been aware of this potential ever since their introduction in 1998, however the recent incidence of Legionella and Listeria infections have prompted this new warning.

Are you taking one of these medications? Read this information from the U.S. Food and Drug Administration:

Information for Patients 

  • TNFα blockers can lower the ability of the immune system to fight infections.
  • Patients should inform their healthcare professional if they are being treated for an infection or have infections that keep coming back.
  • Patients should read the Medication Guide that accompanies their prescription for a TNFα blocker.
  • Patients should contact their healthcare professional if they have any questions or concerns about TNFα blockers.
  • Patients should report serious side effects from the use of TNFα blockers to the FDA MedWatch program, using the information in the "Contact Us" box at the bottom of this page.

As always, discuss your questions and concerns regarding benefits versus risks associated in the use of these medications with your physician.

You can read more about this FDA decision here and here.

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