Tacrolimus (marketed as Protopic Ointment) 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
  • Patient Information Sheet [PDF] or [HTML] (updated 5/2006)
  • Medication Guide (1/19/2006)
• Healthcare Professional Information
  •  Healthcare Professional Information Sheet  [PDF] or [HTML] (3/2005)
    The Protopic Ointment labels have been updated to reflect the safety concern described in the Sheet. (6/2006)
  • Prescribing Information (Protopic Label)

Other Information

• Dear Healthcare Provider Letter (3/2/2006)
• 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 Tacrolimus from Drugs@FDA
• Historical Information

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Date created: February 14, 2005, updated June 26, 2006

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