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FDA: Thinking Outside The Black Box

Today the Food and Drug Administration announced that Pfizer's Chantix and GlaxoSmithKline's Zyban will carry new warnings about mental side effects. Not just any old warnings, but so-called "Black Box" warnings. Or, at least, that's what we in the news media used to call them. Until the FDA called us out today.

Zyban Prescribing Information
Source: us.gsk.com
Zyban Prescribing Information

This is the black box on the Zyban label. It looks pretty much like every other one. It isn't shaded black. It doesn't have a black background with white lettering. It's just a bunch of drug safety-related words doctors and patients should pay attention to that are framed, literally, by a black box. Hence, the term "Black box warning." It's shorthand for the most severe type of warning the FDA can issue. Drugmakers dread it. Investors hate it even more. But, perhaps it will be no more.

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."

The FDA, Pfizer and GSK are all emphasizing what a health burden smoking has become. PFE's Director of Worldwide Communications, Sally Beatty, emailed me to point out that around 70 percent of smokers want to quit, but only three percent are able to do it on willpower alone. On average, she added, smokers try six to nine times in their lifetime to butt out. "We want patients to get the support they need."

When I was growing up my mom was a chain smoker. I hated it. She finally quit cold turkey years after I moved out of the house. But it was too late. She developed kidney cancer, which occurs in cigarette smokers at a much higher rate than non-smokers, and died of metastatic disease.

Chantix sales have already taken a pretty big hit since the reports of mental side effects surfaced about a year-and-a-half ago. And Zyban is a relatively small-selling product for GSK. Sales may shrink even more, though, now that the drugs are getting a new boxed warning. There, you happy FDA? I said it. Boxed is the new black.

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