Long-term Safety of Topical Calcineurin Inhibitors Has Not Been Established
- Although a causal relationship has not been established, rare cases of malignancy (e.g., skin and lymphoma) have been reported in patients treated with topical calcineurin inhibitors, including PROTOPIC Ointment.
- Continuous long-term use of topical calcineurin inhibitors, including PROTOPIC Ointment, in any age group should be avoided, and application limited to areas of involvement with atopic dermatitis.
- PROTOPIC Ointment is not indicated for use in children less than 2 years of age. Only 0.03% PROTOPIC Ointment is indicated for use in children 2-15 years of age.
FDA and Industry Communications
Dear Health Professional Letter (January 2006)
Tacrolimus (marketed as Protopic Ointment) Information
Protopic (tacrolimus), Elidel (pimecrolimus)
Information for Healthcare Professionals: Tacrolimus (marketed as Protopic)
Patient Counseling Information
Updated January 2018