The FDA is considering expanding the warning labels of the Novartis AG cream Elidel (pimecrolimus) and AStellas Pharma’s Protopic (tacrolimus) used to treat eczema. The drugs already carry a strong warning, called a black box warning, about the increased risk of cancer in children.
The documents, released a head of an FDA advisory meeting, are part of a conference to evaluate potential safety concerns with a variety of drugs used in younger patients.
The FDA has received reports of 46 cancer cases and 71 infection cases in patients aged 16 and younger from 2004 to 2008 with these medications, called topical calcineurin inhibitors or TCI’s.
More here.
