Time to Revise the FDA Black Box Warning for Topical Calcineurin Inhibitors?

Graeme M. Lipper, MD


August 24, 2015


Is it time to revise the FDA black box warning for TCIs? According to the PEER data recently reported by Margolis and coworkers, it should at least be considered, as the warning deters parents from using a medication that represents a significant step up from topical corticosteroid monotherapy. It should be noted, however, that the PEER study has only reached the projected halfway point, with investigators expecting to reach 8000 participants and an anticipated 40,000 person-years. Furthermore, the PEER data pertain to pimecrolimus use, although similar encouraging safety data have been reported for topical tacrolimus.[5] Finally, PEER participants used pimecrolimus only intermittently, with a wide range in cumulative dose (60-900 g), so heavier use of this TCI may be associated with risks not detected in the PEER cohort. Nevertheless, even frequent topical TCI use has been associated with negligible systemic absorption,[6] further arguing against any malignancy risk due to systemic immunosuppression.

In sum, we now have more encouraging safety data to report to young patients and parents who might otherwise be scared away from TCI use. This should, in turn, lead to better long-term control of both pediatric and adult AD. It is the responsibility of every prescribing healthcare provider to put the FDA's vague black box warning in proper context.


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