Two anti-smoking drugs to carry severe mental-health warnings

The FDA said Chantix and Zyban will carry the warnings to alert consumers to the risks of depression and suicidal thoughts when using the drugs. The drugs also have been reported to cause changes in behavior, hostility and agitation in users, whether users had a history of psychiatric illness or not.

Two popular anti-smoking drugs will now carry warnings about the risk of severe mental health problems, the Food and Drug Administration announced Wednesday.

The FDA said Chantix and Zyban will carry the warnings to alert consumers to the risks of depression and suicidal thoughts when using the drugs.

The drugs also have been reported to cause changes in behavior, hostility and agitation in users, whether users had a history of psychiatric illness or not. In many cases, side effects started shortly after use began and ended when the medication was stopped. The FDA does not know what is causing the changes and said people taking these products should be monitored by their doctor.

"The risk of serious adverse events while taking these products must be weighed against the significant health benefits of quitting smoking," said Dr. Janet Woodcock, director of the FDA's Center for Drug Evaluation and Research. "Smoking is the leading cause of preventable disease, disability and death in the United States, and we know these products are effective aids in helping people quit."

The agency also is requiring Pfizer Inc., which makes Chantix, and GlaxoSmithKline, maker of Zyban, to conduct a study looking at how often these serious symptoms occur.

Pfizer says it updated its label in 2007 to include information of neuropsychiatric symptoms and has revised the label again to reflect Wednesday's warning.

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