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Elidel and Protopic Label Warnings

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On January 19, 2006 the FDA approved an updated label for Elidel and Protopic. Elidel and Protopic are drugs used to treat atopic dermatitis. Both drugs are calcineurin inhibitor drugs that are used topically to target cells that cause atopic dermatitis in patients. More commonly known as eczema, atopic dermatitis is a non-life-threatening skin condition that causes dry, scaly skin and severe rashes. The new label warns users and physicians that continuous, long-term use of calcineurin inhibitor drugs may cause an increased risk of cancer and lymphoma. It also states that the drugs should not be used on children under the age of 2.

The FDA’s recommendation to include a new, updated label on Elidel and Protopic was based on data collected from animal studies, case reports from patients, and the mechanism of these drugs. Although there is not enough scientific evidence to officially link the use of Elidel or Protopic to cancer, the FDA advises that the drugs only be used as a second line drug (patients should try other treatments first) and should only be used as specified.

The FDA requires that drug manufacturers inform healthcare providers and patients with current, updated information regarding potential risks linked to their drugs as soon as it is available. A recent motion to dismiss a case against Elidel’s manufacturer based on federal preemption grounds was denied.