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Psoriasis drug may raise cancer risk
6-14-08
U.S. drug reviewers said in documents released Friday that an experimental
psoriasis drug called ustekinumab from Johnson & Johnson is effective at
relieving symptoms, but long-term use may raise cancer, Reuters reported.
A spokesman for J&J Centocor unit said the risk was theoretical and the company
planned to monitor the drug safety after the drug is put on the market.
Many types of cancer take 10-plus years to develop and many trials last for only
a few years. Because of this, no elevated risk was observed in trials does not
necessarily mean the drugs are safe for a long term.
The reviewers said the FDA will ask a panel of outside advisers for advice as to
whether or not animal data suggesting an elevated cancer risk should be put on
the label or the company should do more research on the safety issue.
Ustekinumab injections were demonstrated in two company-sponsored trials to be
effective at relieving the severity of symptoms in patients with psoriasis, a
skin disorder that affects an estimated 7.5 million Americans.
The drug suppresses interleukin-12 and interleukin-23, two other immune-system
proteins associated with inflammation.
Animal studies showed suppression of these proteins raised the odds of
developing cancer, which the FDA reviewer said should justify putting the
potential risk on the drug label.
Michael Parks, Centocor spokesman, was quoted by Reuters as saying that "the
risk of malignancies with immunosuppressive therapy is theoretically possible."
If the drug is approved, it will compete with Amgen Inc and Wyeth's Enbrel and
Abbott Laboratories Inc's Humira, which block an inflammation-causing protein
called tumor necrosis factor (TNF).
Prescription information for these drugs includes a warning about a possible
elevated risk of cancer.
The FDA is expected to make its decision whether or not to approve ustekinumab
for sales in the U.S. market in September, Reuters reported.
Comment:
It is just as harmful to block interleukins as tnf. Anytime you mess with the
immune system you are asking for trouble. Almost 60% of psoriasis is caused by
an undiagnosed case of Celiac Disease or another food allergy.
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