Quoted from http://www.msnbc.msn.com/id/31685329/ns/health-addictions/
Chantix, Zyban must carry depression warning
FDA to require smoking cessation drugs to warn of mental health risks
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FDA puts two drugs on suicide watch
July 1: The FDA on Wednesday warned that anyone taking Chantix and Zyban should be watched closely for signs of mental illness because of a growing number of reports of suicide among patients who take the drugs. NBC's Brian Williams reports.Nightly News
updated 7:25 p.m. ET, Wed., July 1, 2009
NEW YORK - The Food and Drug Administration will require two smoking-cessation drugs, Chantix and Zyban, to carry the agency’s strongest safety warning over side effects including depression and suicidal thoughts.
The new requirement, called a “Black Box” warning, is based on reports of people experiencing unusual changes in behavior, becoming depressed, or having suicidal thoughts while taking the drugs.
The antidepressant Wellbutrin, which has the same active ingredient as GlaxoSmithKline PLC’s Zyban, already carries such a warning.
The FDA is also requiring an additional study on Chantix and Zyban to determine the extent of the side effects. Pfizer Inc., which makes Chantix, said it is still discussing the potential study design with the FDA. The study could include patients with and without psychiatric conditions to determine the true incidence rate of psychological side effects, Pfizer officials said.
