Chantix and Zyban Get Suicide Warnings

Mounting reports of suicide among users have led federal regulators to warn that users of Zyban and Chantix should be carefully monitored for signs of serious mental illness. Chantix, made by Pfizer, and Zyban, made by GlaxoSmithKline, are smoking-cessation drugs. In 2007, European officials alerted the FDA about problems with Chantix. Since then, the FDA has received reports of 188 attempted suicides and 98 completed suicides among Chantix users. There have also been 17 reported attempted suicides and 14 completed suicides among Zyban users. Glaxo and Pfizer are required to include the agency’s most serious warning, a black box warning, on the prescribing information for Chantix and Zyban. Further, both Glaxo and Pfizer must conduct clinical trials to examine mental health risks linked to Chantix and Zyban. The manufacturers are also required to mention the risks of suicide in their advertising for the smoking-cessation drugs Zyban and Chantix.