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VA Statement on Smoking Cessation Research Program
Date:6/17/2008

WASHINGTON, June 17 /PRNewswire-USNewswire/ -- Reports in the news media today that the Department of Veterans Affairs (VA) is testing drugs on war veterans are inaccurate and misleading. VA conducts extensive and often groundbreaking, evidence-based research nationwide to discover better health care methods for our veterans. In our PTSD and smoking cessation study, our research is to learn if it is easier to stop smoking when smoking cessation treatment is combined with PTSD therapy, or whether the two therapies are more effective if they are provided separately. In either case, patients are receiving treatment recommended by their own doctors using counseling with or without FDA approved medication that includes Varenicline (Chantix). Participation in this program is voluntary, and all participants are closely monitored clinically by mental health professionals who provide smoking cessation methods patients agree to use.

More than six million prescriptions were written for Varenicline in the United States in 2007; it is an FDA-approved, widely used medication for smoking cessation. In November, 2007, FDA issued an "early communication" to health care providers indicating concerns had arisen about the medication having a possible side effect involving mental health; VA immediately passed along that concern to practitioners at all of our medical centers. On February 1, FDA issued a "Public Health Advisory," to providers, providing more information on potential side effects of which clinicians and patients should be aware. VA distributed this alert to pharmacists in its system on that same day, and to researchers on February 5. FDA has never asked that Varenicline be removed from the market, and it continues to be FDA approved as a safe and efficacious medication.

It is important to note that neither FDA nor the manufacturer has ever recalled Varenicline, and VA has never been asked to do so.

Had a recall been requested, VA would immediate
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SOURCE U.S. Department of Veterans Affairs
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