FDA Considers Warnings for Eczema Creams

The Washington Post ^ | February 12, 2005 | Rob Stein

[neverdem]

Government scientists, concerned that two prescription creams used widely for 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 yesterday on the agency's Web site.

The document was one of several posted in preparation for a meeting of an expert panel next week to assess the safety of the creams and recommend what action the agency should take.

Protopic and Elidel were approved in 2000 and 2001, respectively, to treat eczema, a common, chronic skin condition that causes redness and itching. Before the new creams, the only treatment had been steroid creams and ointments, which can be used only for short periods and can have a variety of side effects.

The new creams, which were seen as effective and much safer, immediately became popular. At least 5 million prescriptions have been written for the creams.

The creams were approved for short-term or intermittent use by adults and children age 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.

"These products are being widely used to treat . . . a non-life-threatening disease, and heavily advertised for use in young children without appreciation . . . regarding the... carcinogenic risk,"

[Paul C. Jesup]

For that matter eczema used to be a common cause of death via widespread secondary skin infections in the pre-antibiotic era.

This statement needs to be repeated as much as possible.

[norwaypinesavage]

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