The Food and Drug Administration (FDA) warns that patients taking the popular stop-smoking drugs Chantix and Zyban should be watched closely for signs of serious mental illness. The warning was issued following mounting reports of bizarre behavior, including suicide, among users of the drugs. Pfizer is the maker of Chantix (varenicline), and GlaxoSmithKine is the manufacturer of Zyban (buproprion). Buproprion is also sold under the brand name Wellbutrin, as a treatment for depression.
Both of the drugs will now be required to carry “black box” labels warning that people who take the drugs should be closely monitored for signs of suicidal thoughts, depression, hostility, and other behavioral changes. In addition, both drug companies will be required to conduct clinical trials for the purpose of assessing the mental health risks associated with the uses of the drugs. Unlike the clinical trials leading to the FDA approval of the drugs, the new trials will enroll smokers with underlying psychiatric disorders. Pfizer has already begun enrollment of schizophrenia patients in a trial.
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