Apr 25, 2014 5:27 PM by Rob Quirk
The Food and Drug Administration announced Friday it will hold a public meeting in October to review the risks of psychiatric and behavioral side effects with Pfizer's anti-smoking drug Chantix.
The agency said in a federal notice it will convene its 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 of links to 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.
At that time, the FDA also required Pfizer to conduct additional studies to determine the extent of the side effects.
A spokeswoman for Pfizer said Friday that the company recently submitted new data to the FDA designed to establish the drug's safety compared with placebo and other anti-smoking therapies.
"Pfizer has proposed an update to the Chantix labeling based on these new data, which, we believe, would better reflect the product's safety profile as it pertains to neuropsychiatric symptoms," said Victoria Davis, in a statement.
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