Quoted from http://www.reuters.com/article/idUSTRE62H2NZ20100318
May need wider eczema caution for kids: FDA
Thu Mar 18, 2010 10:07am EDT
WASHINGTON (Reuters) - Novartis AG and Astellas Pharma eczema drugs may need their warning labels expanded after dozens of new reported cases of cancer and infection in children, U.S. Food and Drug Administration staff said in documents released on Thursday.
Agency scientists said 46 cancer cases and 71 infection cases have been reported in patients aged 16 and younger from 2004 to 2008 with Novartis' Elidel and Astellas' Protopic.
Both drugs -- also known as pimecrolimus and tacrolimus respectively -- already carry strong warnings about cancer and infection, but officials should consider expanding them to include the new post-marketing reports, they wrote.
The documents were released ahead of an FDA advisory meeting Monday to weigh potential safety concerns with a variety of drugs used in younger patients.