* TNF blocker drugs to carry stronger warnings
* Cancer risk occurs about 30 months after treatment-FDA
(Adds Abbott comment, paragraphs 15, 16)
By Susan Heavey
WASHINGTON, Aug 4 Blockbuster prescription
drugs used to treat rheumatoid arthritis and other conditions
can increase the risk of potentially deadly cancer in children
and teenagers, U.S. health regulators said on Tuesday in
ordering stronger warnings on such medications.
The Food and Drug Administration, which urged greater
caution with so-called TNF blockers last September, said an
analysis of 48 reported cancer cases in children using the
drugs "showed an increased risk of cancer, occurring after 30
months of treatment on average."
Eleven of the reported cases were fatal, the FDA said.
Anti-TNF drugs include Johnson & Johnson's (JNJ.N) Simponi
or golimumab and its Remicade or infliximab; Abbott
Laboratories' (ABT.N) Humira or adalimumab; UCB SA's (UCB.BR)
Cimzia or certolizumab pegol; and Amgen Inc (AMGN.O) and
Wyeth's WYE.N Enbrel or etanercept.
Rheumatoid arthritis is an autoimmune disease that can
strike young people, causing pain, stiffness and swelling.
It affects about 20 million people worldwide.
The drugs are used to treat other inflammatory conditions,
including the bowel disorder known as Crohn's disease.
TNF (tumor necrosis factor) blockers make billions of
dollars for manufacturers, but it is unclear how much they earn
specifically from sales for children and teens. Not all of the
drugs are approved for use in children for all related
Last year, Abbott's Humira earned $4.5 billion worldwide,
while Amgen and Wyeth's Ebrel earned $1.2 billion. J&J's
Remicade had 2008 sales of $3.7 billion. Its newer drug,
Simponi, was approved earlier this year. UCB's Cimzia, launched
in 2008, had about $14.4 million in global sales.
The drugs already carry the strongest warnings possible
about the risk of possible serious infections. A new caution
about cancer in younger patients will be added to the so-called
"black box", the FDA said.
EVALUATING THE CANCER RISK
The FDA said in a statement on its website that its
year-long analysis of the increased cancer risk in children
showed about half the 48 cases involved lymphoma, which targets
the immune system.
Rates for cancer cases with J&J's Remicade "were
consistently higher compared to expected background rates for
lymphomas and all malignancies," the FDA said. Cancer rates for
lymphoma were also higher for Amgen and Wyeth's Enbrel, but
rates for all cancers were similar to background rates, the FDA
The FDA did not calculate cancer rates for Abbott's Humira
and UCB's Cimzia "because of minimal use in pediatric
patients." J&J's Simponi was not approved at the time of the
time of the analysis.
The FDA said it had "identified new safety information
related to the occurrence of leukemia and new-onset psoriasis"
that would also be included on the drugs' labeling.
An Abbott spokeswoman said the company would follow the
regulator's new warning guidance.
"We will comply with FDA's guidance regarding labeling
changes for the anti-TNF class and will continue to monitor the
data to ensure patients and physicians have the information
they need to make decisions about treatment," Abbott
spokeswoman Raquel Powers said.
The FDA said it had reviewed 147 reports of leukemia in
adults and children using TNF blockers, including 30 deaths.
While rheumatoid arthritis patients may already be at
greater risk for the white blood cell cancer, "there is a
possible association between treatment with TNF blockers and
the development of leukemia in all patients treated with these
drugs," the FDA said.
The FDA also reviewed 69 cases of psoriasis and said it
found a possible link between the skin disorder and use of TNF
Brian Kenney, a spokesman for Johnson & Johnson's Centocor
Ortho Biotech Inc unit, which makes Remicade and Simponi, said
the company would work with the FDA to adopt the new warnings.
Amgen and Wyeth also said in a statement that they would
revise their product warnings and continue evaluating risks and
benefits of Enbrel.
(Reporting by Susan Heavey; Editing by David Gregorio)