Thursday, January 26, 2006

Elidel & Protopic (Eczema Drugs) Black Box Warnings Added

The Federal Drug Administration (FDA) announced updated labeling for two topical eczema drugs, Protopic Ointment (tacrolimus) and Elidel Cream (pimecrolimus), each made by Novartis.

There will be a black box warning about a possible cancer risk. The boxed warning lets healthcare professionals know that the long term safety of the drugs is yet to be established. What is new? The updated label will say that each drug is to be used as secondary treatment used only after other prescription topical medicines have been tried.

The possible cancer link was first broached in a February 2005 FDA meeting.

For more information, check out the FDA information by going here.