FDA Issues Early Communication to Pfizer for the Drug Chantix

Chrissie Cole

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Chantix, a prescription drug aide to help adults quit smoking, is being evaluated by the FDA for adverse health effects.

Pfizer Inc., the manufacturer, recently submitted reports to the FDA describing suicidal ideation (thoughts). In the aftermath of a recent case that reported erratic behavior while taking Chantix, the FDA also requested any additonal information on cases with any similarities.

The FDA's Center for Drug Evaluation and Research is completing an analysis of available data and information. After the research is compiled and completed, the FDA will announce 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.

For more information on this subject, please visit our section on FDA & Prescription Drugs.