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The Food and Drug Administration announced Friday it will convene a public meeting in October to review the risks of psychiatric and behavioral side effects with Pfizer's anti-smoking drug Chantix.
The agency will gather a panel of psychiatric drug experts to discuss the pill's risks and how to best manage them.
Since 2009 Chantix has carried the government's strongest safety warning — a "black box" label — because it may cause hostility, agitation, depression and suicidal thoughts. The warning was added after the FDA received dozens of reports of suicide and hundreds of reports of suicidal behavior among patients taking the smoking-cessation drug.
The drug's labeling tells patients to stop taking Chantix immediately if they experience agitation, depressed mood, suicidal thinking and other behavioral changes. Doctors are advised to weigh the drug's risks against its potential benefits in helping patients quit smoking.
A spokeswoman for Pfizer said Friday that the company recently submitted new data to the FDA comparing the drug's psychiatric safety to placebo and other anti-smoking techniques.
Just this week, FDA said it would seek to regulate e-cigarettes, and was encouraging research into whether they might help smokers kick the habit.