Re: [SymphonicHealth] 2 Eczema creams required to carry new cancer warnings (fwd)

[Guest guest]

Subject: Re: [symphonicHealth] 2 Eczema creams required to carry new cancer

warnings

The FDA's statment implies that there was inadquate long term study and testing

before the creams approval, yet the creams were allowed for sale and

distribution.

And the FDA wants to remove the nutritional supplement DHEA from the market.

http://news.xinhuanet.com/english/2006-01/20/content_4077326.htm

WASHINGTON, Jan. 19 (Xinhuanet) -- Two prescription creams to treat eczema

will have to carry " black box " warnings about possible cancer risks, the U.S.

Food and Drug Administration (FDA) said Thursday.

The FDA action, in accordance with its advisory committee recommendation

last February, affects Novartis AG's Elidel and Astellas Pharma Inc.'s Protopic.

" Black box " warning is the strongest type used in the United States.

The new labels are also required to clarify that both treatments are

recommended for use only after other prescription topical medicines have been

tried first.

The FDA decision is based on reports of cancers, including skin cancer and

lymphoma, in patients using the two drugs. There had been reports of 78 cases

as of last October. However, no evidence has yet established a clear link

between the drugs and human cancer risk.

Novartis and Astellas continued to defend the safety of their products,

but agreed to make the requested changes in labelling. Meanwhile, the companies

are conducting long-term safety studies.

FDA said in a statement " Although studies are being conducted by the

manufacturers of both drugs to try to answer questions about cancer risk, it

could be many years before the research is concluded. "

Elidel and Protopic are applied to the skin to control eczema by

suppressing the immune system. Eczema is a rash-like inflammation that causes

itchy, red skin. It can also be treated with antihistamines, oral and topical

steroids and over-the-counter products.