New FDA label bolsters safety case for Chantix
WASHINGTON - 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.
Desktop NewsClick to open Continuous News in a sidebar that updates in real-time.
Deputies looking for trucker who may be tied to deadly ATV accident
Head of State Troopers Association arrested after firing gun at office during...
No serious damage to Sunshine Bridge after weekend tanker collision
Undersized culverts source of resident headaches
Witnesses recall group abandoning wounded 14-year-old after Father's Day shooting
'That's typical LSU;' Tailgating underway ahead of Baton Rouge Super Regional
PREVIEW: Southern breaks down Starkville Regional
LSU softball lands national No. 10 seed
Balancing Football and Track: The story of Kary Vincent Jr.
Sha'Carri Richardson's impressive impact on LSU Track and Field