FDA rethinks ‘black box’ warning

About Scott Hensley

Scott Hensley runs NPR's online health channel, Shots. Previously he was the founding editor of The Wall Street Journal's Health Blog and covered the drug industry and the Human Genome Project for the Journal. Hensley serves on AHCJ's board of directors. You can follow him at @ScottHensley.

Quitting smoking, always nerve-racking, may prove even tougher in the wake of a Food and Drug Administration decision to require its strongest warnings for some drugs popular with folks trying to kick the habit.

Pfizer’s Chantix, GlaxoSmithKline’s Zyban, and Zyban’s generic equivalents will now carry a lengthy “boxed warning” about risks of some pretty serious changes in behavior, including hostility and suicidal thoughts, that could dissuade people from using the drugs.


Photo by flattop341 via Flickr

But a “boxed warning?” Hey, FDA, don’t you mean “black box warning?” That’s the way the agency has long been proud to talk about the toughest warning at its disposal. Well, maybe not so much anymore.

CNBC’s Mike Huckman tweeted during an agency call with reporters about the rowback: “FDA official wants media to stop using term ‘Black Box’ & just say ‘Boxed Warning.’ ‘Black Box carries implication ‘Don’t u dare use this.””

Forbes’s Matt Herper wrote that during the call Robert Temple, director of the FDA’s drug evaluation office said the beefed-up boxed warnings on Chantx and Zyban aren’t meant to stop people from using smoking-cessation drugs. “Smoking is really bad for you,” Temple said. “What you want is that people don’t [use the drugs] casually.”

What’s a reporter to do? U.S. News and World Report health writer Katherine Hobson poked FDA on Twitter, “What’s a better substitute for ‘black box warning’? Gentle reminder?”

How about, “Whoa! You sure you really wanna take this pill?”

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