FDA Reviews Arthritis Drugs for Links to Childhood Cancer
After receiving 30 reports of children and young adults developing cancer
while taking arthritis drugs over the last 10 years, the FDA is investigating
to see if there is a link, especially for younger children.
The drugs under investigation include:
Humira (Abbott Labs)
Remicade (Shering-Plough)
Enbrel (Amgen Inc. and Wyeth)
Cimzia (UBC, Belgium)
The drugs, called tumor necrosis factor blockers (TNF blockers), are prescribed to children
with a certain type of arthritis, and work by blocking a chemical that causes
inflammation. Formerly known as Juvenile Rheumatoid Arthritis (JRA), the condition is now
known as Juvenile Idiopathic Arthritis (JIA). The drugs are sometimes also used to treat
children with an intestinal disorder known as Crohn's disease.
About half of the cancers reported were lymphomas, a cancer of the immune system.
Other cancers reported were leukemia, melanoma, and various organ cancers. The FDA
says that long-term studies will be required to accurately determine the risks, since
cancers can take years to develop. The Belgian drugmaker UBC is being required to conduct
such a long-term study on Cimzia, but it won't be complete until 2019.
The FDA has been aware of the possible association of a link between taking the drugs and
developing cancer, and the drugs' labels currently contain warnings. Manufacturers of these
drugs are being asked to provide the FDA with all available information about the 30 cases
in which cancer developed, and the FDA will work with experts and issue its findings in about
six months.
For now, the FDA believes that the benefits of the drugs still outweigh the risks, and is
simply advising doctors and caregivers to consider the risks of cancer when considering
prescribing the drug to children.
