Chantix, Zyban get Black Box warnings from FDA
July 2nd, 2009 joshua
The popular and extremely controversial stop-smoking drugs Chantix and Zyban have received the Food and Drug Administration’s most stern warning.
Regulators ruled earlier this week to place its Black Box warning on the labels of all lots of Chantix and Zyban to notify physicians, pharmacists and consumers of their link to severe psychological side effects, including suicidal behavior and thoughts.
Thousands, if not more than a million people have been subscribed Chantix or Zyban to help quit smoking. Off-label applications of the drug were to treat Post Traumatic Stress Disorder.
However, as more people began receiving Chantix, more reports began to surface of aggressive and suicidal behavior in those taking it.
Reports of soldiers being given Chantix upon returning from tours of active duty were also noted, including a military program to use Chantix in such a way, despite it not being approved to treat PTSD.
In mandating the warning, the FDA also wants further study on the drugs to determine the extent of the side effects.
