SNY

Black Box warnings are the most severe type of warning that the FDA can require for a pharmaceutical. They can indicate a wide range of potential risks, with varying degrees of probability, but one thing is for sure. The the term Black Box is downright scary and it frequently highlights a serious, though perhaps very improbable, health risk such as, well, death.

Still, to be fair, it could be simply telling me about a suicide risk that has 1/100th the probability of me similarly dying when I get behind the wheel of a car. And given the dark name, I'm far less inclined to risk the Black Box warning than to drive to the corner store. So perhaps this is a problem, that the term Black Box is too scary even if it does warn of some pretty unfortunate risks.

It appears the FDA has recognized this since they are beginning to phase-out the term with some better word choice. Is it fair if we call this a re-branding of the Black Box?

On the FDA conference call with reporters this afternoon to discuss the new warnings, two agency officials told the news media to use the phrase "Boxed warning" instead of "Black box warning." Why? As one of them put it, "Black box carries the implication, 'Don't you dare use this'." The other official added, "We don't want to scare people off (from trying to quit smoking). We just want them to be carefully monitored."