FDA panel recommends 'black box' warnings for eczema creams

From my research into eczema, it is a rather complex or the cause of it.

According to the "I-Medicine Sutra" Skin disease is closely related to the health of Lung & Large Intestine & Colon.

The abstract element of Lung; Large Intestine & Colon is Metal. It is the imbalance of "Chi" or conflicts between "Metal" & "Wood" that caused the Skin Disease.

Eczema can be due to the environment pollutions, humilities, the type of food such as prawn, crabs or certainly fish, also some people may be sensitive to alcohol. There is a possibility that the DNA of the of person & their family DNA. The other factor is Stress.

Using of drug must be very careful, such as using steriod & order toxine cream for the skin.

Sea water or hot spring may be a better alternative to heal the eczema.


FDA panel recommends 'black box' warnings for eczema creams
By Donna Leinwand, USA TODAY
ROCKVILLE, Md. — Two popular medicines used to treat eczema should carry a warning about a potential risk for cancer and infection, a Food and Drug Administration advisory panel recommended Tuesday.

The medicines, Elidel and Protopic, were approved originally as second-line treatments for eczema, a skin disorder, to be used when traditional treatment with steroid creams did not work or caused a reaction. But both creams have become popular with parents who believe they are safer than steroid creams.

POSSIBLE RISKS

The Food and Drug Administration is looking into reports that lymph node cancer and other cancers have occurred in children and adults using Elidel and Protopic.

What they treat:
Elidel is for mild to moderate atopic dermatitis, a form of eczema. Protopic is for moderate to severe atopic dermatitis. Neither drug is recommended as a first-line treatment.

Who should not use them:
Among those are children younger than 2 years old, women who are breastfeeding, or anyone whose eczema is infected.
What are the risks?
Lymph node cancer, skin cancer (limit exposure to natural or artificial sunlight), increased chance of chickenpox or shingles.
Source: FDA

One of the creams, Elidel, is advertised often on television and in women's magazines as a safe alternative to steroid creams.

FDA officials said at a hearing Tuesday that they were highly concerned that several animals, including primates, developed cancer in studies of the drugs.

An advisory panel of pediatricians, dermatologists, consumer advocates and other scientists concluded Tuesday that the drug labels should include "black box" warnings about the potential cancer risk and the danger of prescribing the creams for children younger than 2.

"Black boxes" — literally printed black boxes enclosing the warnings — are considered the strongest possible labeling. The FDA usually heeds the advice of its professional panels.

"There are animal models that make us concerned that these products could contribute to an increase in cancer," said Dianne Murphy, director of the Office of Pediatric Therapeutics for the FDA. "We have no human proof, but the monkey data was very concerning."

Murphy calls the potential for cancer "biologically plausible."

"We don't want to scare people," Murphy said. "We just want to make people more informed."

Novartis, the manufacturer of Elidel, said in a statement issued after the hearing that the black box warning was "unwarranted and not substantiated by clinical evidence." About 5 million people worldwide are using the drug, Novartis said.

The FDA raised the issue of a potential cancer risk at a hearing in 2003 when early animal studies showed some signs of cancer.

Several members of the panel said then that they were alarmed by the study and wanted more direct warnings on the label. But the panel stopped short of voting for a black-box warning.

Use of the medicines has increased more than fourfold over the past four years, FDA documents show.

Physicians wrote almost 2 million prescriptions for children between June 2003 and May 2004, the FDA said. Doctors also prescribed the creams for about 500,000 children younger than 2. The creams are not recommended for infants.

USATODAY.com - FDA panel recommends 'black box' warnings for eczema creams