Stop Smoking Drugs Get Black Box Warnings

Pfizer’s smoking cessation drug Chantix and GlaxoSmithKline’s Zyban will both receive black box warnings for their potentially fatal side effects. Both drugs have been linked to suicidal tendencies and the FDA has issued a public health advisory about them.
In part, the FDA advisory states, “People who are taking Chantix or Zyban and experience any serious and unusual changes in mood or behavior or who feel like hurting themselves or someone else should stop taking the medicine and call their healthcare professional right away.
Friends or family members who notice these changes in behavior in someone who is taking Chantix or Zyban for smoking cessation should tell the person their concerns and recommend that he or she stop taking the drug and call a healthcare professional right away.”
Behavioral changes in those taking the stop smoking drugs have been noted for since 2007 and there have been reports of suicides among those taking Chantix.
The black box warnings will appear prominently in the packaging inserts as well as any marketing materials associated with the drugs.
The black box warning for Zyban caught some industry insiders by surprise. While the problems associated with Chantix have been well known, Zyban’s troubles began when officials began examining Chantix. Zyban, a re-branded version of the anti-depressant Wellbutrin, was approved for use as a stop smoking drug in 1997.