Black Box Warning Should Remain on Chantix: Panel

From the WebMD Archives

Oct. 17, 2014 -- A black box warning about suicide risks should remain on the anti-smoking drug Chantix until it can be reevaluated using findings from thorough scientific studies, a U.S. Food and Drug Administration panel of experts said Thursday.

Chantix has carried the FDA's strongest warning label since 2009 after it was linked to violent or suicidal behavior among some patients taking the drug.

Pfizer asked the FDA to drop the boxed warning, citing recent studies suggesting that patients taking Chantix were not at increased risk for psychiatric problems, the Associated Press reported.

However, the 11-member FDA advisory panel voted to retain the black box warning on Chantix. One member voting in favor of removing the warning and six favored slight changes to the label.

The FDA does not have to follow the advice of its expert panels, but typically does.

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