According to a Reuters report, US FDA staff have suggested that the warning labels for pimecrolimus (Elidel®) and tacrolimus (Protopic®) may need to be expanded, to include details of post-marketing reports of cancer and infection in children.  There have been 46 reported cases of cancer and 71 of infection in patients aged ≤16 treated with pimecrolimus or tacrolimus for eczema, between 2004 and 2008. 

These concerns are included in documents released ahead of a meeting on Monday, where potential safety concerns with a variety of drugs used in younger patients will be discussed.  Other recommendations made by the panel and outside advisors will be considered by the FDA before any action is taken.