WASHINGTON (AP) — Public safety advocates are asking the federal government to strengthen warnings on Pfizer’s anti-smoking drug Chantix, even as the drugmaker prepares to argue that a bold-letter warning about psychiatric problems should be removed from the medicine’s label.
Five advocacy groups petitioned the Food and Drug Administration on Wednesday to expand Chantix’s boxed warning, calling for more detailed language about potential side effects like suicidal behavior, hostility and depression. The groups also say that the prominent warnings should include information about blackouts, convulsions and other problems reported in some patients.
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