Jul 7 2009 UPDATE –People using two popular anti-smoking drugs, Chantix and Zyban, are being advised to exercise caution due to reports received by the Food and Drug Administration (FDA) that may link the medications to mental illness. Both products will receive the FDA's most serious caution – a black box warning.
The FDA has received 98 reports of suicide and 188 reports of suicide attempts from people using Chantix, which is made by Pfizer. There have been 14 suicide and 17 attempted suicide reports among those using Zyban. Zyban is produced by GlaxoSmithKline and also sells under the brand name Wellbutrin, which is prescribed for depression.
Although officials at the FDA believe that individuals should not necessarily quit using the products because of the warning, they are advising caution when using them.
Oct 2008 ORIGINAL ALERT –The Food and Drug Administration (FDA) has said that it may once again strengthen warnings on Pfizer's antismoking drug Chantix. The agency is currently reviewing a report issued by the Institute for Safe Medicine Practices that claims there were 1,001 adverse incidents linked to the medication in the first quarter of this year.
If the institute's analysis is correct, this means that Chantix was linked to more serious reactions than the top 10 most-prescribed brand-name drugs combined. Among the incidents reported, 15 were linked to traffic accidents and 52 were linked to blackouts.
Pfizer has questioned the institute's findings, saying that there is not sufficient medical evidence to make any conclusions. Chantix has already been linked to serious side effects such as depression and suicidal behavior, and Pfizer strengthened the drug's warning label in 2007. A report issued in May 2008 linked the medication to 173 accidents, some involving automobiles. This report resulted in the Department of Transportation, the Federal Aviation Administration, and the Department of Defense banning pilots, air traffic controllers, and others from using Chantix.