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New Warnings About TNF Blockers

The human immune system is complex and more is being learned about it all the time. A substance produced by some of the immune system cells is called Tumor Necrosis Factor (TNF). It is a molecule that helps to regulate immune cells by carrying messages between them.

If you have a chronic inflammatory disease, too much TNF can be produced and that causes even more inflammation. Examples of chronic inflammatory diseases are:

  • Crohn’s disease
  • Juvenile idiopathic arthritis (JIA)
  • Psoriatic arthritis
  • Rheumatoid arthritis
  • Plaque psoriasis

Drugs have been developed called TNF blockers to treat these conditions. The drug names are Simponi, Humira, Cimzia, Remicade, and Enbrel.

FDA Studies of TNF Blockers
From the U.S. and other countries, 48 reports were sent to the FDA of childhood cancer apparently connected to use of TNF blockers. Starting in 2001, the FDA did a study of these drugs and in 2008 they released their conclusions. TNF blockers increase the risk of lymphoma, leukemia, and “other malignancies” in children, teens, and adults.

Last week the FDA called for new warnings on TNF blocker labeling and information sheets. The Boxed Warning will now warn doctors about the increased risk of cancer. There will also be an updated Warnings section that will include leukemia information relevant to all ages; and the Adverse Events section will now include text about increased risk for psoriasis with use of TNF blockers.

If you have a child who is taking a TNF blocker, try to be alert for any symptoms of cancer, such as:

  • Weight loss
  • Fatigue
  • Increased bleeding or bruising
  • Swollen lymph nodes

You might also want to watch your child’s skin for red patches and bumps which could indicate psoriasis. Please contact your child’s doctor if you have any concerns.

If you have already noticed suspicious symptoms, either in your child or yourself, please contact our pharmaceutical litigation attorneys. We will be happy to schedule a free case evaluation for you.

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