FDA Labeling Changes:
Elidel Cream and Protopic Ointment
The FDA announced the approval of updated labeling
for two topical eczema drugs, Elidel Cream (pimecrolimus)
and Protopic Ointment (tacrolimus). The labeling will
be updated with a boxed warning about a possible risk
of cancer, and a Medication Guide will be distributed
to help ensure that patients using these prescription
medicines are aware of this concern.
The following links provide summaries and information
sheets.
http://www.fda.gov/cder/drug/infopage/elidel/default.htm
http://www.fda.gov/cder/drug/infopage/protopic/default.htm |