Chantix (varenicline) is a prescription medication that contains no nicotine and is used to help adults quit smoking. Chantix contains no nicotine, but it targets the same receptors that nicotine does, it is believed to block nicotine from these receptors.

Recently the FDA requested information from the manufacturer, Pfizer, Inc., and the company submitted reports to the agency describing suicidal ideation (thoughts). In the wake of a case report citing erratic behavior in an individual who had used Chantix, FDA has also asked the company for any information on additional cases that may be similar in patients who have taken the drug.

FDA’s left for Drug Evaluation and Research is working to complete an analysis of the available information and data. When this analysis is completed, FDA will communicate the conclusions and recommendations to the public.

In the meantime, FDA recommends that health care providers monitor patients taking Chantix for behavior and mood changes. Patients taking Chantix should contact their doctors if they experience behavior or mood changes.

FDA also advises that, due to reports of drowsiness, patients should use caution when driving or operating machinery until they know how using Chantix may affect them.

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