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FDA Medwatch Alert: Elidel Cream (pimecrlimus)
Posted 20 Jan 2006 by Drugs.com
[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] Read more
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FDA Medwatch Alert: Elidel (pimecrolimus)
Posted 10 Mar 2005 by Drugs.com
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] Read more
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Eczema, Atopic Dermatitis, Contact Dermatitis, Perioral Dermatitis