Drug safety- FDA concern about black box warning

[Guest guest]

Dear Members,

The boxed warning represents the FDA’s highest risk level for prescription medications; however, no guidelines exist that demarcate what events prompt the FDA to issue such a warning.

The US Food and Drug Administration (FDA) introduced a boxed warning label in February 15, 2005 for the topical calcineurin inhibitors (TCIs) pimecrolimus and tacrolimus based on the rationale that systemic immunosuppressives are associated with an increased risk of lymphoma and of squamous cell carcinoma (SCC). Topical immunosuppresives may predispose to malignancy.

The boxed warning label was implemented based on data relating to oral and not topical tacrolimus or pimecrolimus (prescribed for atopic dermatitis).

Tarun Wadhwa