Safety Concerns Enter the Eczema Picture

Eczema Creams' Safety A Concern
February 12, 2005Washington Post

WASHINGTON -- 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 warnings to the product labels.A handful of cases of cancer have been reported among adults and children using the creams, sold under the 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 website.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 was approved in 2000 and Elidel in 2001 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, quickly 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 ages 2 and older, but both creams are believed to be widely used for longer periods and on babies.Both Novartis and Fujisawa Healthcare Inc., which makes Protopic, defended the safety of their products to the FDA."Elidel is an effective, steroid-free treatment for mild to moderate eczema and has a well-established safety profile," Novartis spokesman Tom Jones said in an e-mail.