Labeling for Chantix and Zyban will be updated to include a Black Box Warning regarding their link to mental health events, including changes in behavior, depressed mood, hostility, and suicidal thoughts. A Black Box Warning is the Food & Drug Administration’s (FDA) most serious safety notice.
It should be of no surprise to readers of this blog that Chantix is getting such a serious safety warning, as its problems are well-documented. The FDA actually began investigating its link to psychiatric side effects in late 2007. In 2008, Chantix maker Pfizer elevated the prominence of safety information regarding suicidal thoughts and other psychiatric problems to the warnings and precautions section of the Chantix prescribing information, or labeling. However, many consumer advocates, including the group Public Citizen, want the FDA to go further and highlight the Chantix suicide risk with a Black Box warning. (more…)

