FDA MedWatch- Remicade, Enbrel, Humira and Cimzia- FDA Investigating Tumor Necrosis Factor Blockers And Cancer Risk In Children And Young Adults

[Guest guest]

FDA MedWatch- Remicade, Enbrel, Humira and Cimzia- FDA Investigating Tumor

Necrosis Factor Blockers And Cancer Risk In Children And Young Adults

Sent: Wednesday, June 04, 2008 3:55 PM

Subject: FDA MedWatch- Remicade, Enbrel, Humira and Cimzia- FDA Investigating

Tumor Necrosis Factor Blockers And Cancer Risk In Children And Young Adults

FDA issued an Early Communication About an Ongoing Safety Review to inform

healthcare professionals that the Agency is investigating a possible association

between the use of Tumor Necrosis Factor (TNF) blockers and the development of

lymphoma and other cancers in children and young adults. FDA is investigating

approximately 30 reports of cancer in children and young adults. These reports

were submitted to FDA's Adverse Event Reporting System over a ten-year interval,

beginning in 1998 through April 29, 2008. These reports describe cancer

occurring in children and young adults who began taking TNF blockers (along with

other immuno-suppressive medicines such as methotrexate, azathioprine or

6-mercaptopurine), when they were ages 18 or less, to treat juvenile idiopathic

arthritis, Crohn's disease or other diseases. Approximately half of the cancers

were lymphomas, including both Hodgkin's and non-Hodgkin's lymphoma. Long-term

studies are necessary to provide definitive answers about whether TNF blockers

increase the occurrence of cancers in children because cancers may take a long

time to develop and may not be detected in short-term studies. Until the

evaluation is completed, healthcare providers, parents, and caregivers should be

aware of the possible risk of lymphoma and other cancers in children and young

adults when deciding how to best treat these patients.

Read the entire 2008 MedWatch Safety Summary, including a link to the FDA's

Early Communication About n Ongoing Safety Review of Tumor Necrosis Factor (TFF)

Blockers regarding this issue at:

http://www.fda.gov/medwatch/safety/2008/safety08.htm#TNF

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[Guest guest]

----- Forwarded Message ----From: "carwol@..." carwol@...I remember that when I first came into the group some 8 years ago, there were several sisters whose children had developed Rheumatoid Arthritis by their late teens -- This item might possibly be of interest to them. If you know if any are still around --and your have their addresses--please forward to them...Carolyn=============Date: Wed, 4 Jun 2008 14:55:06 -0500 (CDT)From: "U.S. Food & Drug Administration (FDA)" <fda@...>Subject: FDA MedWatch- Remicade, Enbrel, Humira and Cimzia- FDAInvestigating Tumor Necrosis Factor Blockers And Cancer Risk In ChildrenAnd Young Adultscarwol@...MedWatch logo MedWatch - The FDA Safety Information and Adverse Event Reporting Program FDA issued an Early Communication About an Ongoing Safety Review to inform healthcare professionals that the Agency is investigating a possible association between the use of Tumor Necrosis Factor (TNF) blockers and the development of lymphoma and other cancers in children and young adults. FDA is investigating approximately 30 reports of cancer in children and young adults. These reports were submitted to FDA's Adverse Event Reporting System over a ten-year interval, beginning in 1998 through April 29, 2008. These reports describe cancer occurring in children and young adults who began taking TNF blockers (along with other immuno-suppressive medicines such as methotrexate, azathioprine or 6-mercaptopurine), when they were ages 18 or less, to treat juvenile idiopathic

arthritis, Crohn's disease or other diseases. Approximately half of the cancers were lymphomas, including both Hodgkin's and non-Hodgkin's lymphoma. Long-term studies are necessary to provide definitive answers about whether TNF blockers increase the occurrence of cancers in children because cancers may take a long time to develop and may not be detected in short-term studies. Until the evaluation is completed, healthcare providers, parents, and caregivers should be aware of the possible risk of lymphoma and other cancers in children and young adults when deciding how to best treat these patients. Read the entire 2008 MedWatch Safety Summary, including a link to the FDA's Early Communication About n Ongoing Safety Review of Tumor Necrosis Factor (TFF) Blockers regarding this issue at: http://www.fda.gov/medwatch/safety/2008/safety08.htm#TNF

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