Sep 24, 2014 11:02 AM
New FDA label bolsters safety case for Chantix
The Associated Press
WASHINGTON (AP) New government-approved labeling on Pfizer's drug Chantix suggests that the anti-smoking medication may not carry the risks of suicidal behavior that first earned it the government's strongest warning more than five years ago.
The FDA has updated the drug's label to include data from a number of recent studies that found little to no evidence of psychiatric problems or suicidal tendencies in patients taking the tablet.
The new labeling represents a victory for Pfizer, which requested the update from regulators.
Company executives say they will now ask the FDA to remove Chantix's so-called black box label the strongest type which warns prescribers of links to hostility, agitation, depression and suicidal behavior.
The FDA is convening a panel of experts next month to review Chantix's risks, at Pfizer's request.