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FDA Re-Branding the Black Box Warning: How to Make Potential Death More Palatable

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."

Situation: Sanofi's Lantus Cancer Scare Shows How Enormous Power Lies With Few Experts

Research Reloaded: 

Cancer fears over Sanofi's drug Lantus seem premature and overdone, and the whole affair has shown how a few experts can really shake markets even if their beliefs aren't necessarily proven. Sanofi shares have rebounded a bit after falling on the news, but at $29.5 are still below recent $33 levels.


 

The cancer scare over Sanofi-Aventis' Lantus shows just how much power over a company's drug sales -- and its stock -- are now concentrated in the hands of a tiny number of experts. Sanofi CEO Chris Viehbacher came out of his corner swinging Monday, saying an article in Study of Diabetes journal Diabetologia that called for more research into a potential link between Lantus and cancer was "of poor quality." He also said that "quick and dirty" studies of the link were not the answer.

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