Pimecrolimus (marketed as
Elidel Cream)
Information
The Food and Drug Administration (FDA) has approved updated
labeling on January 19, 2006 for two topical eczema drugs, Elidel
Cream (pimecrolimus) and Protopic Ointment (tacrolimus). The new
labeling includes a boxed warning about a possible risk of cancer
and a Medication Guide (FDA-approved patient labeling). The
Medication Guide is to be distributed with each prescription to help
ensure that patients using these prescription medicines are aware of
this concern. The new labeling also clarifies that these drugs are
recommended for use as second-line treatments. This means that other
prescription topical medicines should be tried first. Use of these
drugs in children under 2 years of age is not recommended.
- Patient Information
- Healthcare Professional Information
- Healthcare Professional Sheet [PDF]
or [HTML]
The Elidel Cream labels have been updated to reflect the
safety concern described in the Sheet. (6/2006)
-
Prescribing Information
(Elidel Label)
Other Information
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Date created: February 14, 2005, updated June 26, 2006 |