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U.S. Department of Health and Human Services

Safety

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Elidel Cream (pimecrolimus)

Elidel Cream (pimecrolimus)
Protopic Ointment (tacrolimus) 

 

Audience: Dermatological and other healthcare professionals
[Posted 01/20/2006] The Food and Drug Administration 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 (FDA-approved patient labeling) will be distributed 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.

[January 19, 2006 – Elidel Information Page – FDA]
[January 19, 2006 – Protopic Information Page – FDA]
[January 27, 2006 – Elidel letter – FDA]
[January 19, 2006 – Protopic Letter – FDA]