WASHINGTON (AP) — 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 says in a federal notice it will convene its panel of psychiatric drug experts to discuss the pill's risks and how to manage them.
Since 2009 Chantix has carried the government's strongest safety warning due to links to hostility, agitation, depression and suicidal thoughts. The warning was added after the FDA received dozens of reports of suicide and suicidal behavior among patients taking Chantix.
At that time the FDA also required Pfizer to conduct additional studies.
A spokeswoman for Pfizer said Friday that the company recently submitted new data to the FDA designed to show the drug's safety.