Cancer Risk With Topical Immunosuppressants Subject Of Pediatric Advisory Cmte. Meeting
This article was originally published in The Pink Sheet Daily
Executive Summary
Risk management strategies, including evaluation and communication, will be discussed at the Feb. 15 meeting. The advisory committee will also meet Feb. 14 to hear pediatric adverse event updates for several drugs.
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Risk management strategies for the potential risk of cancer in pediatric patients treated with topical dermatologic immunosuppressants will be the subject of FDA's Pediatric Advisory Committee meeting Feb. 15. Risk evaluation, labeling, risk communication and dissemination of information on potential cancer risk among pediatric patients treated for atopic dermatitis with topical dermatologic immunosuppressants will be discussed. Topical immunosuppressants, such as Fujisawa's Protopic (tacrolimus) and Novartis' Elidel (pimecrolimus), have emerged as steroid alternatives for treatment of AD. Labeling for both products includes an extensive section on carcinogenicity. The committee will meet on the afternoon of Feb. 14 to receive adverse event reporting updates for Lotensin (benazepril), Brevibloc (esmolol), Malarone (atovaquone/proguanil), Viracept (nelfinavir), Xenical (orlistat) and Glucovance (glyburide/metformin), as required by the Best Pharmaceuticals for Children Act. FDA will also ask the committee "how to improve the process and content of the adverse event reviews and reporting as mandated by BCPA." [Editor's Note: To 1 watch a webcast or order a video/DVD of this meeting, visit FDAAdvisoryCommittee.com.] - Mary Jo Laffler |