The FDA (US Food and Drug Administration) has published a Public Health Advisory to health care professionals, patients, as well as caregivers, concerning varenicline (Chantix), a prescription drug aimed at helping people give up smoking. Last November the FDA informed in an Early Communication to doctors and the public that it was evaluating post-marketing adverse event reports on Chantix, specifically linked to behavior changes, actual suicidal behavior, suicidal ideation, depressed mood and agitation. As the FDA's review of adverse event reports continues, it seems increasingly probable that there may be a link between Chantix and significant neuropsychiatric symptoms. Therefore, the FDA has asked Chantix's manufacturer, Pfizer, to elevate the prominence of this safety information to the warning and precautions section of the Chantix prescribing information/labeling. Moreover, the Agency is working with the manufacturer to complete a patient's Medication Guide. "This is an example of FDA working with drug manufacturers throughout products' lifecycles to keep health care professionals and patients informed of new and emerging safety data," the FDA reports. Bob Rappaport, M.D., Director, Anesthesia, Analgesia and Rheumatology Products, FDA said "Chantix has proven to be effective in smokers motivated to quit, but patients and health care professionals need the latest safety information to make an informed decision regarding whether or not to use this product. While Chantix has demonstrated clear evidence of efficacy, it is important to consider these safety concerns and alert the public about these risks. Patients should talk with their doctors about this new information and whether Chantix is the right drug for them, and health care professionals should closely monitor patients for behavior and mood changes if they are taking this drug." Chantix, which was approved by the FDA in May 2006 to aid smoking cessation, acts at parts of the brain that nicotine affects and may assist people who want to give up smoking. It can ease the nicotine addict's withdrawal symptoms by blocking the effects of nicotine from tobacco if users resume smoking - in other words, if you relapse and have a cigarette, the nicotine is less likely to hit that spot in the brain. In the Public Health Advisory and a Health Care Professional Sheet that was also issued, the Agency stressed the following safety information for patients, caregivers, and health care professionals: -- If you are a patient you should tell your doctor about any history of psychiatric illness that existed or has existed before you start/started on Chantix. -- There is a possibility that Chantix may aggravate a current psychiatric illness, even if that illness is currently under control. -- Taking Chantix raises the risk that an previous psychiatric illness reoccurs. The FDA comments that patients with these illnesses were not included in the studies that were carried out for the drug's approval. -- Doctors, patients, and families/caregivers of patients should be on the lookout for changes in mood and behavior in patients taking Chantix. They should be especially vigilant for symptoms that include anxiety, nervousness, tension, depressed mood, unusual behaviors and thinking about or attempting suicide. In most cases, neuropsychiatric symptoms developed during Chantix treatment, but in others, symptoms developed following withdrawal of varenicline therapy. -- Any changes in mood and behavior should be reported to the patient's doctor. The FDA reports that it is not uncommon for a patient taking Chantix to experience unusual or strange dreams. Some patients may find it harder to operate heavy machinery and/or drive. The FDA says that it will continue to keep health care professionals informed with new information from the Agency's continuing review or if new information is received on Chantix and serious neuropsychiatric symptoms. FDA may request further revisions to the labelling or taking other regulatory action as the agency's continuing reviews and conclusions warrant.

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