Protopic, Elidel Safety Labeling May Be Reviewed, FDA Tells Pediatric Cmte.
Executive Summary
FDA plans to discuss the pediatric safety profile of topical immunosuppressants with Novartis and Fujisawa after an advisory committee recommended stronger warnings about the potential carcinogenicity of Elidel and Protopic
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Topical immunosuppressant cancer risk management
Strategies for cancer risk associated with the use of topical immunosuppressants in children being treated for atopic dermatitis will be discussed at the Feb. 15 meeting of FDA's Pediatric Advisory Committee. The topic was also discussed in 2003 (1"The Pink Sheet" Nov. 10, 2003, p. 41). [Editor's Note: To 2watch a webcastor order a video/DVD of this meeting, visit FDAAdvisoryCommittee.com.]...