Federal health advisers say a bold-letter warning about suicide risks with Pfizer's Chantix should remain on the anti-smoking drug until it can reevaluated based on new, rigorous study information.
Eleven advisers to the Food and Drug Administration voted to retain the so-called black box warning about reports of suicide, hostility and depression among Chantix patients. Six advisers said the label should be slightly changed and one panel member voted to remove the warning completely.
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The twice-a-day tablet has carried the Food and Drug Administration's strongest warning label since 2009, following reports of suicidal tendencies and violent or bizarre behavior among some patients. Pfizer Inc. has asked the FDA to drop the boxed warning, pointing to recent studies suggesting there is no increased risk of psychiatric problems among people taking Chantix.