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April 2005, Volume 35 Number 4 , p 30 - 30



© 2005 Lippincott Williams & Wilkins, Inc. Volume 35(4)             April 2005             p 30 FDA panel warns of cancer risks [DRUG NEWS: TOPICAL ECZEMA THERAPY]

An FDA advisory panel has recommended aggressive steps to warn consumers about cancer risks associated with two topical prescription drugs, pimecrolimus (Elidel) and tacrolimus (Protopic), which are indicated to treat atopic dermatitis (eczema) in certain patients. Both drugs work by suppressing the immune system and are approved for use in patients age 2 and older.

Among its recommendations, the advisory panel urged adding a prominent “black box” to labels warning of an increased risk of certain cancers, especially among children. Although administered topically, the drugs can be absorbed through the skin; because children have a greater ratio of body surface area to body mass than adults, they're especially vulnerable ...

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