The Food and Drug Administration (FDA) 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.
Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program using the contact information at the bottom of this page.
FDA Approves Updated Labeling with Boxed Warning and Medication Guide for Two Eczema Drugs, Elidel and Protopic
FDA news release (1/19/2006)
- Elidel Prescribing Information (Labeling)
- Elidel Medication Guide (PDF - 96KB)
Information for Healthcare Professionals: Pimecrolimus (marketed as Elidel)[ARCHIVED]
- Historical Information on Pimecrolimus (Elidel) [ARCHIVED]