Early Communication for Smoking Cessation Product Chantix

On Nov. 20, 2007, FDA announced that it is evaluating adverse event reports for Chantix (varenicline), a prescription medicine to help adults stop smoking.

The manufacturer, Pfizer, Inc., recently submitted reports to FDA describing suicidal 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. There are also reports of patients experiencing drowsiness that affected their ability to drive or operate machinery.

FDA’s Center 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

  • Health care providers should monitor patients taking Chantix for behavior and mood changes.
  • Patients who take Chantix should contact their doctors if they experience behavior or mood changes.
  • Patients should use caution when driving or operating machinery until they know how using Chantix may affect them.

Early Communication

FDA has issued an Early Communication about an Ongoing Safety Review of Chantix. An Early Communication reflects FDA’s current analysis of available data and does not mean the agency has concluded that there is a causal relationship between the drug and the emerging safety issue.

For More Information

Full text of the Early Communication about Chantix
http://www.fda.gov/cder/drug/early_comm/varenicline.htm