Elidel Warning!

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 ELIDEL Cream.

Therefore:

• Continuous long-term use of topical calcineurin inhibitors, including ELIDEL Cream, in any age group should be avoided, and application limited to areas of involvement with atopic dermatitis.
• ELIDEL Cream is not indicated for use in children less than 2 years of age.

Prolonged systemic use of calcineurin inhibitors for sustained immunosuppression in animal studies and transplant patients following systemic administration has been associated with an increased risk of infections, lymphomas, and skin malignancies. These risks are associated with the intensity and duration of immunosuppression.

Based on this information and the mechanism of action, there is a concern about a potential risk with the use of topical calcineurin inhibitors, including ELIDEL Cream. While a causal relationship has not been established, rare cases of skin malignancy and lymphoma have been reported in patients treated with topical calcineurin inhibitors, including ELIDEL Cream. Therefore:

ELIDEL Cream should not be used in immunocompromised adults and children.

• If signs and symptoms of atopic dermatitis do not improve within 6 weeks, patients should be re-examined by their healthcare provider and their diagnosis be confirmed.
• The safety of ELIDEL Cream has not been established beyond one year of non- continuous use.

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