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Elidel FDA Alerts

The FDA Alert(s) below may be specifically about Elidel or relate to a group or class of drugs which include Elidel (pimecrolimus).

MedWatch Safety Alerts are distributed by the FDA and published by Following is a list of possible medication recalls, market withdrawals, alerts and warnings. For the latest FDA MedWatch alerts, go here.

Recent FDA Alert(s) for pimecrolimus

Elidel Cream (pimecrlimus)

Jan 20, 2006

Audience: Dermatological and other healthcare professionals

[Posted 01/20/2006] The Food and Drug Administration announced the approval of updated labeling for two topical eczema drugs, Elidel Cream (pimecrolimus) and Protopic Ointment (tacrolimus). The labeling will be updated with a boxed warning about a possible risk of cancer and a Medication Guide (FDA-approved patient labeling) will be distributed 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. p>
[January 19, 2006 – Protopic Information Page – FDA]
[January 27, 2006 – Elidel letter – FDA]

Elidel (pimecrolimus)

Mar 10, 2005

Audience: Dermatological and other healthcare professionals

The FDA issued a public health advisory to inform healthcare providers and patients about a potential cancer risk from use of Elidel (pimecrolimus) and Protopic (tacrolimus), products that are applied to the skin. This concern is based on information from animal studies, case reports in a small number of patients, and how these drugs work. It may take human studies of ten years or longer to determine if use of Elidel or Protopic is linked to cancer. In the meantime, this risk is uncertain and FDA advises that Elidel and Protopic should be used only as labeled, for patients who have failed treatment with other therapies.

[March 10, 2005 - Public Health Advisory - FDA]
[March 10, 2005 - Talk Paper - FDA]
[March 10, 2005 - Elidel Drug Information Page - FDA]
[March 10, 2005 - Protopic Drug Information Page - FDA]

More Elidel Resources