Two Eczema Drugs Should Have Cancer Warning -- FDA

http://www.healthsentinel.com/news.p...st_item&id=678

Maggie Fox, "Two Eczema Drugs Should Have Cancer Warning -- FDA",
Reuters, March 11, 2005,
Link:
http://www.reuters.com/newsArticle.j...toryID=7872988

Two eczema creams, Elidel and Protopic, should carry a strong advisory
about a cancer risk, the U.S. Food and Drug Administration said on
Thursday in a warning disputed by the manufacturers.

Research shows the creams are absorbed into the body and may have the
potential to cause cancer, said the FDA, which is working on a "black
box" warning for the salves -- the strongest warning carried on
medicines.

Babies should not be treated with the creams at all, it said.

But Novartis AG, which makes Elidel, disputed the FDA's call for a
black box warning and said there would be no change in its label for
the time being.

"FDA has informed Novartis that we will begin discussions about the
type of label and the exact wording contained in the label within the
next few weeks. There is no change in the label at this time," Novartis
said in a statement.

The American Academy of Dermatology, which represents skin specialists,
also questioned the move.

"Because these medications are applied to the skin, virtually none of
it gets inside the body," dermatologist Dr. Clay Cockerell, president
of the academy, said in a statement.

"These are valuable medications, and if used properly they
significantly reduce the debilitating impact of eczema and allow
millions of our patients to live normal lives."

The FDA usually negotiates changes in drug labeling with the makers.
But the agency has been under fire from consumer groups and Congress,
which question whether the agency does enough to monitor the side
effects of medications after they are approved for the market.

COMPANY SAYS CREAM SAFE

"Novartis agrees that patients suffering from mild to moderate eczema
need to be informed about the safe and effective use of Elidel, but we
believe a recommendation to add a black box warning to the label is
unsubstantiated by clinical evidence and experience in more than five
million patients worldwide," the company said.

The FDA said animal studies showed a link with cancer. Tests of whether
an agent can cause cancer are done on animals because it would be
unethical to experiment on humans.

"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.

They included seven cases of lymphoma and six of skin cancer.

Japan's Fujisawa Pharmaceutical Co. Ltd., which makes Protopic, said in
Osaka that it has not found any scientic human data or evidence to
clearly link Protopic to a cancer risk and believes it has provided
sufficient information to ensure doctors and patients will use the drug
safely.

Fujisawa spokeswoman Hideko Nakamura said its U.S. unit, Fujisawa
Healthcare Inc., is looking closely into the FDA warning but has not
yet decided how to deal with it.

"Our local unit has been promoting the proper use of Protopic and it
has said it would be willing to consider any other or additional
measures to help improve the way it provides information about the
proper use of the drug," Nakamura said.

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 that the creams are not approved
to treat.

Elidel, known generically as pimecrolimus, 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.

"Both products are applied to the skin to control eczema by suppressing
the immune system," the agency said. Suppressing the immune system is
known to potentially contribute to cancer.

Doctors who prescribe the drugs should remember they should be used
only for the shortest time possible, the FDA said.

"Elidel and Protopic are not approved for use in children younger than
2 years old," it said.

Novartis stock closed down 12 cents at $48.70 on the New York Stock
Exchange on Thursday.

Fujisawa shares rose 0.8 percent to 2,640 yen by mid-afternoon on
Friday in Tokyo, in line with a rise in the benchmark Nikkei average.