Posted by TENA/ DIAMOND on 11/23/2008, 8:17 pm
Crohn's Disease Drug Cleared for Children
Thu Nov 20, 2008 1:15 am (EST)
Crohn's Disease Drug Cleared for Children
By ANDREW BRIDGES, Associated
Press Writer
Federal regulators approved Remicade as a treatment for Crohn's disease in
children on Friday, just days after publication of a study linking the
Johnson & Johnson drug to an increased risk of some cancers in rheumatoid
arthritis patients.
The Food and Drug Administration said that expanding availability of the
injectable drug would provide a much-needed option for children who suffer
from Crohn's, in which chronic inflammation of the walls of the intestines
can cause diarrhea, cramping, abdominal pain and bleeding. In 1998, Remicade
became the first approved treatment for Crohn's disease in adults.
"We believe that the potential benefits of this product outweigh the risks
that are known and have been carefully evaluated," said Dr. Steven Galson,
director of the FDA's Center for Drug Evaluation and Research, in a
statement.
Approval comes after Wednesday's publication in the Journal of the American
Medical Association of a study in which researchers said they found an
apparent link between Remicade and a second drug, Humira, and some types of
cancer in rheumatoid arthritis patients. Those cancers include skin,
gastrointestinal, breast and lung tumors.
The FDA-approved labeling for Remicade, also called infliximab, already
mentions the drug's association with an increased risk of lymphoma and other
cancers, including skin, breast and colorectal, the regulatory agency and
the drug's manufacturer both said. The label also mentions an increased risk
of serious and sometimes fatal infections, as well as disorders of the blood
and central nervous system.
Centocor, a J&J subsidiary, and Abbott Laboratories, which makes Humira,
previously said the JAMA study does not prove their drugs are at fault and
added that the research was flawed.
"The issue is that it's not really new news," Centocor spokesman Michael
Parks said Friday. "This information is covered in our label."
The FDA also said it has received reports of an aggressive and frequently
fatal form of lymphoma in adolescent and young adult Crohn's patients
treated with drugs that suppress the immune system and, in most cases,
Remicade as well. The agency said it was working with Centocor to further
revise Remicade's label to reflect those findings as well. Centocor's Parks
stressed that none of the lymphoma patients had received Remicade alone.
Both Crohn's and rheumatoid arthritis are autoimmune diseases, in which the
immune system attacks the body's soft tissues, including those that line the
intestines and joints.
Remicade, a genetically engineered monoclonal antibody, works by binding to
a protein that contributes to the chronic inflammation that is a hallmark of
autoimmune diseases, according to the FDA
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