The Food and Drug Administration will ask a panel of experts later this week whether a bold-letter warning on the anti-smoking drug Chantix should be removed based on company-supported evidence that the drug does not cause suicidal behavior.
Pfizer's twice-a-day tablet has carried the FDA strongest warning label, known as a black box, since 2009 because of reports of suicidality, hostility and depression. But the New York drugmaker points to recent studies and analyses suggesting there is no difference in psychiatric problems between people taking Chantix and other smoking-cessation aids.
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Still, the FDA notes in briefing documents posted online that there is little precedent for removing a boxed warning. And the agency will ask its panel of outside efforts whether more data is needed before consider removing the warning language.