only 10 million at risk for cancer from Eczema drugs...

[Guest guest]

SSRI-Research@

Fri, 20 Jan 2006 09:57:58 -0500

[sSRI-Research] only 10 million at risk for cancer from

Eczema drugs...

 

 

 

[-- sound familiar????]

 

 

FDA to Require Warnings on 2 Eczema Drugs

 

http://news./s/ap/20060120/ap_on_he_me/eczema_warning

 

By ANDREW BRIDGES, Associated Press Writer 9 minutes ago

 

The labels on two prescription creams to treat eczema will have to

bear " black box " warnings of possible cancer risks.

 

The Food and Drug Administration action Thursday follows an agency

advisory committee recommendation last February that Elidel cream and

Protopic ointment carry the label warnings.

 

The new labeling also will clarify that the two drugs are recommended

for use only after other prescription topical medicines have been

tried by patients, the FDA said. The agency is also issuing a guide

updating patients of its concerns.

 

A black box warning is the most serious type of warning in

prescription drug labeling. The warning will be located lower on the

labels of the two drugs than is typical, although a statement higher

on the labels will refer to the risk.

 

" This is something that is a possible risk, is a long-term possibility

and is something that still needs to be researched, " FDA spokeswoman

Susan Cruzan said.

 

As of October, the FDA has received reports of 78 cases of cancers,

including skin and lymphoma, in patients treated with the two drugs,

said Dr. Stanka Kukich, the acting director of the FDA's dermatologic

and dental drug products division.

 

Novartis Pharmaceuticals, which makes Elidel, said in a statement

Thursday that it remained confident in the safety and efficacy of Elidel.

 

" While Novartis believes this action is not substantiated by

scientific or clinical evidence, Novartis has agreed to make the

requested changes, " the company said.

 

Astellas Pharma Inc., formed through the merger of Protopic maker

Fujisawa Healthcare Inc. and Yamanouchi Pharmaceutical Co., said in a

statement that its drug " is safe and effective when used in a manner

consistent with its label. "

 

" It addresses a theoretical risk - a potential risk, not a

demonstrated link, " Dr. Joyce Rico, vice president for medical

sciences research and development at Astellas, said of the warning.

 

While the two manufacturers dispute whether there is a cancer link,

the FDA felt it had to convey notice of the cancer reports to doctors

and patients, said Dr. Julie G. Beitz, an acting director of one of

the FDA's drug evaluation offices.

 

Along with the small number of cancers reported in both children and

adults treated with the drugs, animal tests have shown an increase in

cancer associated with the drugs, the FDA said last year.

 

No causal link between use of the drugs and cancer has been

established, Beitz said. [oh - of course not....]

 

The long-term safety of the drugs has not been established [so what

else is new?], according to the FDA. While both companies are studying

that issue, the results may not be known for years, the FDA said.

 

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

suppressing the immune system.

 

The companies estimate that roughly 10 million people combined have

used the two drugs.

 

___

 

On the Net:

 

Food and Drug Administration: http://www.fda.gov

 

Novartis Pharmaceuticals: http://www.novartis.com/

 

Astellas Pharma Inc.: http://www.astellas.com/

 

2006 The Associated Press. All rights reserved. The

information contained in the AP News report may not be published,

broadcast, rewritten or redistributed without the prior written

authority of The Associated Press.

 

 

2006 Inc. All rights reserved.

Questions or Comments

Privacy Policy -Terms of Service - Copyright/IP Policy - Ad Feedback