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The popular stop-smoking drugs Chantix and Zyban will carry strong "black box" warnings on risky mental health side effects, as suicides among users of the drugs continue to rise, the FDA announced today.
The new warnings will be required on the prescribing information for Chantix (made by Pfizer) and Zyban (manufactured by GlaxoSmithKline), and "will highlight the risk of serious mental health events including changes in behavior, depressed mood, hostility, and suicidal thoughts when taking these drugs," the FDA says.
The "black box" warnings -- so named because the cautionary information must be prominently displayed inside a black box, set off against other text in the drug's packaging -- were ordered based on reports of mental health problems and suicidal behavior submitted to FDA safety officials.
According to the FDA, people taking Chantix and Zyban "have reported experiencing unusual changes in behavior, become depressed, or had their depression worsen, and had thoughts of suicide or dying. In many cases, the problems began shortly after starting the medication and ended when the medication was stopped."
In recent years, there have been 98 suicides and 188 attempted suicides among people taking Chantix , the New York Times is reporting today.
The FDA acknowledges that people taking Chantix and Zyban are in the process of quitting smoking, and that people may experience things like depression, anxiety, irritability, and restlessness as a result of nicotine withdrawals. But, the agency points out, "some patients who were using these products experienced the reported adverse events while they were still smoking."