- WASHINGTON (Reuters) - Two
eczema creams -- Novartis AG's Elidel and Fujisawa Healthcare, Inc.'s Protopic,
must carry a strong warning of cancer risk, the U.S. Food and Drug Administration
said on Thursday.
-
- Research shows the creams are absorbed into the body
and can cause cancer, the FDA said. The creams will carry a "black
box" warning -- the strongest warning carried on medicines.
-
- And babies should not be treated with the creams at all,
the FDA said.
-
- "The data showed that the risk of cancer increased
as the amount of the drug given increased. The data also included a small
number of reports of cancers in children and adults treated with Elidel
or Protopic," the FDA said in a statement.
-
- In February members of an FDA advisory panel said they
were concerned the companies were aggressively advertising the medicines
to treat infants and others with skin problems the creams are not approved
to treat.
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- Elidel, known generically as pimecrominum, and Protopic
known generically as tacrolimus, should be used only as directed and only
after other eczema treatments have failed to work because of the risk,
the FDA said.
-
- Since the FDA approved Protopic in 2000 and Elidel in
2001, seven cases of lymphoma and six skin cancer cases have been reported
in patients, the FDA said.
-
- Animal tests have suggested the creams could cause cancer,
the FDA added.
-
- "The manufacturers of the products have agreed to
conduct research to determine whether there is an actual risk of cancer
in humans, and, if so, its extent," the FDA said.
-
- "Both products are applied to the skin to control
eczema by suppressing the immune system. FDA's Public Health Advisory specifically
advises physicians to weigh the risks and benefits of these drugs in adults
and children," the agency added.
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- Doctors who prescribe the drugs should remember they
should be used only for the shortest time possible, it said.
-
- "Elidel and Protopic are not approved for use in
children younger than 2 years old," the FDA added.
-
- "The long-term effect of Elidel and Protopic on
the developing immune system in infants and children is not known. In clinical
trials, infants and children younger than 2 years of age treated with Elidel
had a higher rate of upper respiratory infections than those treated with
placebo cream."
-
- According to the National Institutes of Health (NIH),
about 15 million Americans, including about 20 percent of children, suffer
from eczema, a skin inflammation that can cause itchy thick skin with blisters
or scaly patches.
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