Safety Alerts & Recalls

What does this mean?

This early communication is in keeping with FDA's commitment to inform the public about its ongoing safety reviews of drugs. Since TNF blockers are used to treat serious medical conditions, and since most doctors have been aware of a possible link between TNF blockers and cancer for some time, the FDA believes that the benefits of treatment still outweigh the risks based on current evidence.

That said, until the FDA's investigation is complete, any healthcare providers, parents or caregivers should be aware of the possible risk of lymphoma and other cancers when deciding on a course of treatment - and should have a monitoring plan in place to detect early problems.

If you currently provide care to a child or young adult receiving TNF blocker therapy, please click the following link to receive ongoing information on this issue.

http://www.iGuard.org/tnfblock.ig?hk=_uid&ver=_code

Early communication regarding cancer link in children

The FDA has issued an early communication today regarding a possible link between the use of medicines known as tumour necrosis factor (TNF) blockers (such as Certolizumab) and the development of lymphoma and other cancers in children and young adults. The FDA is currently investigating this issue and will continue to report as new information emerges.

Today's announcement follows approximately 30 reports of cancer in children and young adults treated with TNF blockers for Juvenile Idiopathic Arthritis (JIA), Crohn's disease or other diseases. While cancers are known to occur in children and young adults, these reports in children and young adults receiving TNF blockers are of concern and have prompted the FDA's further investigation.

Source: FDA
Publication Date: 2008-06-04
Last Updated: 2009-12-06

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