In January 2006, the FDA recommended that two prescription medications for eczema—Elidel® cream (pimecrolimus) and Protopic® ointment (tacrolimus)—carry a black box warning, the strongest safety warning the agency issues. These medications belong to a class known as topical calcineurin inhibitors, which act on the immune system to reduce inflammation.
The FDA issued the warning because, between October 2005 and January 2006, the agency received 78 reports of cancers in patients using the medications, including lymphoma and skin cancer. In addition, some animal studies showed an increased cancer signal when the drugs were used systemically or at high exposures.
Because of these concerns, the FDA recommended that Elidel and Protopic be used only after other prescription eczema treatments had been tried, particularly in children.
