FDA eyes warnings for eczema creams

WASHINGTON – Government scientists, concerned that two prescription creams used widely to treat eczema, a common skin condition, may increase the risk of certain cancers, especially among children, will propose adding strong new warnings to the product labels.

A handful of cases of cancer have been reported among adults and children using the creams, sold under brand names Elidel and Protopic, and animal and laboratory studies suggest the drugs could be to blame, according to a new Food and Drug Administration analysis.

“The evidence raises serious safety concerns in children regarding the potential for carcinogenicity in humans treated with these agents,” wrote Jean Temeck of the FDA’s division of pediatric drug development in a recommendation posted late Friday on the agency’s Web site.

Protopic and Elidel were approved in 2000 and 2001, respectively, to treat eczema, a common, chronic skin condition that causes redness and itching. They were meant for short-term or intermittent use by adults and children ages 2 and older, but Novartis Pharmaceuticals Corp. has marketed Elidel aggressively, and both creams are believed to be widely used for longer periods and among babies.