Elidel, Protopic May Increase Cancer Risk

Yael Waknine

Disclosures

January 19, 2006

Jan. 19, 2006 — The US Food and Drug Administration (FDA) has approved revisions to the safety labeling for 1% pimecrolimus cream ( Elidel, made by Novartis Pharmaceuticals Corporation) and tacrolimus 0.03% and 0.1% ointment ( Protopic, made by Astellas Pharma, Inc), advising of the potential risk for cancer associated with their use.

The revisions will include a new boxed warning and a medication guide for patients that emphasize appropriate use of these drugs to minimize this risk, according to a news release sent today from the FDA.

The agency has received postmarketing reports of lymphomas and skin malignancies (basal cell and squamous cell carcinoma, and malignant melanoma) in patients using topical calcineurin inhibitors such as pimecrolimus and tacrolimus.

Although a causal relationship has not been established and studies are being conducted by the manufacturers of both drugs to address this potential risk, the FDA notes that it may be many years before conclusive data is obtained regarding their long-term safety.

In the interim, continuous long-term use of these drugs should be avoided in all age groups and their application limited to areas affected by atopic dermatitis.

The FDA also emphasized that topical tacrolimus and pimecrolimus should not be used in children younger than 2 years, and that only 0.03% tacrolimus ointment is indicated for use in children aged 2 to 15 years.

Pimecrolimus cream 1% is indicated as second-line therapy for the short-term and noncontinuous chronic treatment of mild to moderate atopic dermatitis in nonimmunocompromised adults and children aged 2 years and older who have failed to respond adequately to other topical prescription treatments, or when those treatments are contraindicated.

Tacrolimus ointment (0.03% and 0.1% for adults; 0.03% for children aged 2 to 15 years) is indicated as second-line therapy for the short-term and noncontinuous chronic treatment of moderate to severe atopic dermatitis in nonimmunocompromised adults and children who have failed to respond adequately to other topical prescription treatments, or when those treatments are not advisable.

Healthcare professionals are encouraged to report adverse events related to use of pimecrolimus or tacrolimus to the FDA's MedWatch safety information and adverse event reporting program by phone at 1-800-FDA-1088, by fax at 1-800-FDA-0178, online at https://www.fda.gov/medwatch , or by mail to 5600 Fishers Lane, Rockville, MD 20852-9787.

Reviewed by Gary D. Vogin, MD

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