An FDA advisory panel voted on Thursday in favour of keeping a black boxed warning on the label of Pfizer's smoking cessation therapy Chantix (varenicline). Eleven panellists voted in support of maintaining the warning about the risks of adverse effects including suicide, hostility and depression associated with the therapy, while six panellists suggested that the label should be altered slightly, with one committee member recommending removal of the warning entirely.
The FDA added the warning in 2009 following reports linking the treatment to neuropsychological effects, including suicidal thoughts and erratic behaviour. In documents released ahead of the panel vote, FDA reviewers also expressed support for maintaining the black box warning on the drug's label. Agency staff have indicated that any decision regarding removal of the black box warning should not be issued until Pfizer completes a required large-scale study comparing the psychiatric side effects of Chantix and buproprion.
Pfizer has asked the US regulator to remove the warning, noting that recent studies identified no association between Chantix and an increased risk of psychological problems. However, the advisory panel determined that the warning should remain on the drug's label until it can be re-evaluated based on new, rigorous study data.
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