Most Popular in:

Regulations

Email This Item! Print This Item!

Two Eczema Drugs Receive Black Box Warning Labels

Posted: January 23, 2006

Two prescription skin creams used to treat eczema -- Elidel and Protopic -- will have to carry black box label warnings that they may pose possible long-term cancer risks, the U.S. Food and Drug Administration said Thursday.

A black box warning is the most serious type of alert.

The FDA also said the two drugs' labels must clarify that the creams are for use only after other prescription topical medications have been tried by patients, the Associated Press reported.

This action is based on a recommendation made last February by an FDA advisory committee. As of last October, the FDA had received reports of 78 cases of cancers in patients treated with the two creams. The cancers included lymphoma and skin cancer.

"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 told the AP.