FDA Makes Rare Call, Removes Boxed Warning From Chantix, Zyban Labels
Pfizer, GSK score as neuropsychiatric symptom risks now only appear in Warnings and Precautions section following EAGLES trial results.
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FDA could use advisory committee members' comments to maintain the smoking cessation drug's boxed warning, even though they voted to remove it.
Those patients need more options for smoking cessation, Pfizer says, but that is the group FDA most worries about when deciding whether to remove its boxed warning.
When industry rep questioned whether problems with smoking cession drug trial were overestimated, FDA's rebuke was swift.