The Food and Drug Administration will allow Pfizer to remove a serious warning from the label of its anti-smoking drug Chantix, reports Fox News.
While Chantix was approved 10 years ago, the FDA placed the "black box" warning on the drug's label in 2009 after thousands of users reported mental health side effects.
In September, a FDA advisory panel voted 10-9 that the warning — which highlights psychiatric risks like suicidal thoughts, hostility and agitation — should be removed from Chantix's label.
The FDA's decision was based on results of a clinical trial that showed Chantix does not significantly increase the prevalence of mental health side effects in users.
While the warning can be removed from the label, the FDA will still require Pfizer to feature post-marketing reports of the drug's serious side effects on the label, according to the report.
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