Summary

The Food and Drug Administration said Tuesday there’s an increased risk of lymphoma and other cancers associated with the use of drugs like Remicade [infliximab] and Humira [adalimumab] in children and adolescents.  The FDA is requiring stronger warnings regarding the risk for cancer associated with tumor necrosis factor (TNF) blockers.


 

Analysis

FDA’s safety information and adverse event reporting program, states that the warnings will include an updated boxed warning and highlight the increased risk for cancer in children and adolescents who take TNF blockers for the treatment of juvenile rheumatoid arthritis, Crohn’s disease, and other inflammatory diseases. 
 
These drugs work by neutralizing a protein that, when overproduced, causes inflammation and damage to bones, cartilage and other tissue.  FDA scientists said that after more than a year of review the drugs appear to increase the risk of cancer after they are used beyond 2 1/2 years.
 
We are reminded that new drugs must continue to be studied when in use in the general population as new side effects and delayed events can be the result of these new, useful and powerful medications.  Certainly, the younger the patient the greater the concern level that should be exercised about  prolonged exposure to any medication.
 
Continued post-market approval studies are always needed, especially when powerful medications are to be used in the pediatric age group.
 
FDA Warns on Cancer Risk In Immune-System Drugs – http://online.wsj.com/article/SB10001424052970204313604574330702054833562.html?mod=googlenews_wsj
 
FDA: Arthritis drugs pose cancer risk to children – http://www.google.com/hostednews/ap/article/ALeqM5gwU2Cj_4MEY0NDkE6OUtYyKHrBOQD99SBSSO1
 
Arthritis Drugs to Carry Warning on Kids’ Cancer Risk – http://www.bloomberg.com/apps/news?pid=newsarchive&sid=aNB2zQF.rHdw
 
FDA Updates Warnings for TNF Blockers and Cancer Risk – http://www.medscape.com/viewarticle/706973
 
Certain Arthritis, Crohn’s Drugs May Raise Kids’ Cancer Risk: FDA -  http://healthday.com/Article.asp?AID=629711
 
Remicade – http://www.remicade.com/remicade/global/index.html
 
Centacor Inc – http://www.centocor.com/centocor/index.html
 
Humira – http://www.humira.com
 
Abbott – http://www.abbott.com/
 

Analyses are solely the work of the authors and have not been edited or endorsed by GLG.