Eczema drugs linked to cancer risk, says FDA
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Eczema drugs linked to cancer risk, says FDA
Elidel and Protopic creams to
carry 'black box' warnings
Updated: 3:07 p.m. ET March 10, 2005
WASHINGTON - Two eczema creams — Novartis AG¡¯s Elidel and
Fujisawa Healthcare, Inc.¡¯s Protopic, must carry a strong warning of cancer
risk, the Food and Drug Administration said 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.
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.
Drugs linked to lymphoma, skin
cancer
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.
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, 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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