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 bolded warning about psychiatric problems should be removed from its medicine's label.
Five advocacy groups are petitioning the Food and Drug Administration to expand Chantix's boxed warning, which currently warns of potential side effects like mood changes, depression, hostility and suicidal behavior. The groups say the label should be expanded to include risks of blackouts, convulsions and other problems reported in some patients.
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The FDA petition comes just a week before the FDA meets publicly to review Chantix's risks. Pfizer has conducted several studies showing no link with suicidal behavior and the company plans to argue that the boxed warning is no longer warranted.