http://www.fda.gov/cder/drug/early_comm/TNF_blockers.htm
Early Communication About an Ongoing Safety Review of Tumor Necrosis
Factor (TNF) Blockers
(marketed as Remicade, Enbrel, Humira, and Cimzia)
FDA is investigating the possible association between the use of
medicines known as tumor necrosis factor (TNF) blockers and the
development of lymphoma and other cancers in children and young
adults. These individuals were treated with TNF blockers for Juvenile
Idiopathic Arthritis (JIA), Crohn=92s disease or other diseases. JIA is
the new name for what was called Juvenile Rheumatoid Arthritis (JRA).
FDA is investigating approximately 30 re****ts of cancer in children
and young adults. These re****ts were submitted to FDA=92s Adverse Event
Re****ting System over a ten-year interval, beginning in 1998 after
approval of the first TNF blocker, and extending through April 29,
2008. These re****ts described 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 (JIA), Crohn=92s disease or other diseases.
Approximately half the cancers were lymphomas and included both
Hodgkin=92s and non-Hodgkin=92s lymphoma. Lymphoma is a cancer of the
cells in the immune system. Lymphoma is not a recognized complication
of JIA or of Crohn=92s disease. Other cancers re****ted included
leukemia, melanoma, and solid organ cancers. While cancers are known
to occur in children and young adults, the re****ts of these events in
children and young adults receiving TNF blockers are of concern and
deserve further investigation. 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.
TNF blockers suppress the immune system by blocking the activity of
TNF, a substance in the body that can cause inflammation and lead to
immune system-related diseases. There are currently four TNF blockers
available in the United States. Remicade, Enbrel, Humira, and Cimzia
are each approved to treat one or more of a number of immune system
diseases including JIA, rheumatoid arthritis, psoriatic arthritis,
plaque psoriasis, Crohn=92s disease, and ankylosing spondylitis.
Remicade is approved for use in children to treat Crohn=92s disease.
Enbrel and Humira are approved for use in children to treat JIA.
FDA has been aware of the possible association between the use of TNF
blockers and the development of cancer. The prescribing information
for all four TNF blockers warns about the possible risk of cancer.
FDA is also aware of the risk of hepatosplenic T cell lymphoma in
children and young adults with Crohn=92s disease treated with Remicade
and immunosuppressive drugs such as azathioprine or 6-mercaptopurine.
This risk was described in the Remicade prescribing information in
2006.
FDA has asked the makers of the TNF blockers approved for use in
children (Remicade, Enbrel, and Humira) to provide information about
all cases of cancer re****ted in children taking TNF blockers. The
maker of Cimzia is required to conduct a study to *****s long-term
risks of the product, including lymphoma and other cancers. This
study will begin in 2009 and take about 10 years to complete. FDA has
contacted medical experts to *****s the potential association between
TNF blockers and cancers, including lymphoma, and to determine if
there are children and young adults with JIA and Crohn=92s disease who
may be at particular risk for developing a lymphoma or other cancer.
This early communication is in keeping with FDA=92s commitment to inform
the public about its ongoing safety reviews of drugs. FDA will
communicate the conclusions and any resulting recommendations to the
public after it completes its evaluation of the new information within
about six months. At the current time, the FDA believes that the
potential benefits of the use of TNF blockers outweigh the potential
risks in certain children and young adults having one of the diseases
for which the TNF blockers are approved to treat. 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.
The FDA urges both healthcare professionals and patients to re****t
side effects from the use of Remicade, Enbrel, Humira, and Cimzia, to
the FDA's MedWatch Adverse Event Re****ting program.
* by re****ting online at www.fda.gov/medwatch/re****t.htm;
* by returning the postage-paid FDA form 3500 available in PDF
format at www.fda.gov/medwatch/getforms.htm to 5600 Fishers Lane,
Rockville, MD 20852-9787;
* by faxing the form to 1-800-FDA-0178; or
* by phone at 1-800-332-1088.
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Luke
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