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"Black Box" For Protopic, Elidel Is "Blunt" But Necessary Instrument, Advisory Cmte. Says

This article was originally published in The Pink Sheet Daily

Executive Summary

Although noting that data suggesting a cancer risk from the topical eczema treatments is not definitive, the panel concludes that a black box warning is the best approach to discourage off-label use. A medication guide should also be mandated, the committee says.

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