Recently the FDA’s Pediatric Advisory Committee met to discuss the level of adverse events and malignancies reported with the use of Novartis’ Elidel^® and Fujisawa’s Protopic^®. According to the FDA neither agent is genotoxic and do not interact directly with DNA, however, they may have a potential to impair local immune system function. A data summary of the cancer related adverse events reported can be found at:

For Elidel^® http://www.fda.gov/cder/drug/infopage/elidel/default.htm
For Protopic^® http://www.fda.gov/cder/drug/infopage/protopic/default.htm

The FDA Pediatric Advisory Committee recommendations to the FDA were to implement a “Black Box” warning and patient medication guide for both agents.

Both agents are approved for second-line use in atopic dermatitis in patients two years of age and older in whom the use of alternative, conventional therapies is deemed inadvisable because of potential risks, or in the treatment of patients who are not adequately responsive to or intolerant of alternative, conventional therapies.

Effective 4-1-2005, the University of Michigan Prescription Plan will not cover Elidel^® or Protopic^® for children under the age of 2 years.