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Protopic (tacrolimus)

March 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]

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