The unintended effects of a boxed warning

To demonstrate a real-life correlation that after the US Food and Drug Administration introduced a boxed warning concerning malignancies to the labeling for topical calcineurin inhibitors, reluctance to use topical calcineurin inhibitors has led to their substitution with other therapies that have their own risks.

An anonymous survey of attendees of the 2007 Fall Clinical Dermatology conference in Las Vegas, Nevada, from October 17-19, 2007. More than 95 percent of attendees were dermatologists; a small number of mid-level practitioners attended as well. Of nearly 700 attendees, the first 504 who agreed to complete the survey were included.

More than 40 percent of dermatologists surveyed claimed that more than 20 percent of their atopic dermatitis patients are not adequately controlled since the introduction of the boxed warning. Forty-eight percent claim that more than 20 percent of those patients were adequately controlled with topical calcineurin inhibitors as part of their regimens. Eighty percent of dermatologists surveyed agree that more than 10 precent of those patients were adequately controlled with topical calcineurin inhibitors in their regimens.

While caution is usually prudent, the introduction of a boxed warning in the case of topical calcineurin inhibitors has led to the use of treatments that often have greater risks than the topical calcineurin inhibitors that they replaced.