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
  • Medication Guide (1/19/2006)
• 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

• FDA Approves Updated Labeling with Boxed Warning and Medication Guide for Two Eczema Drugs, Elidel and Protopic. FDA News (1/19/2006)
• Regulatory History of Pimecrolimus from Drugs@FDA
• Historical Information

Adverse reactions or quality problems experienced with the use of this Product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax, using the contact information at the bottom of this sheet.