Public Health Advisory Issued by FDA on Chantix

February 7, 2008, 11:30AM. By Ginger Gillenwater

Rockville, MDA Public-Health Advisory has been issued by the US Food and Drug Administration to caregivers, health care providers, and patients regarding new warnings that concern the stop smoking prescription medication, Chantix.

An Early Communication was issued to health care providers and the public by the FDA on November 20, 2007, regarding the evaluation by the agency of the reports stating that there had been adverse events related to the use of Chantix. Such events included: agitation, changes in behavior, suicidal ideation, depressed mood, and actual suicide.

As the agency continues to review the reports regarding these adverse events, it is appearing that there may indeed be a connection between Chantix and the neuropsychiatric symptoms of those who are taking Chantix. As a result of this evaluation, the FDA has made a request to Pfizer, the manufacturer of the drug, that they increase the prominence of this information to the public via their prescribing information and labeling so that health care providers and the public may be aware of the precautions and warnings regarding use of the drug. Also, the FDA and Pfizer are working together in finalizing a Medication Guide for patients to review upon taking the drug. This shows the FDA's efforts to work with drug manufacturers throughout the lifecycles of products. Such action keeps both the health care provider and the patient informed of any new safety data.

It is true that Chantix has been effective in motivating smokers to quit smoking, but it is important for health care providers and patients to have the most recent information regarding safety of the drug in order to make the right decision of whether to use or not to use it. This is what the FDA's director of the Division of Anesthesia, Analgesia and Rheumatology believes. He does say that Chantix has demonstrated very clear evidence that it works, but that it is important to acknowledge all safety concerns and make sure the public is aware of them all. It is important for patients to talk to their doctors about this new information and whether or not they should take Chantix to stop smoking. Health professionals can closely monitor the patients for any mood or behavior changes while taking the drug, but the information has to be available first.

It was in May 2006 that the FDA approved Chantix as a drug to help people stop smoking. Chantix has an influence on the parts of the brain that are stimulated by nicotine and helps those who are trying to stop smoking by easing the withdrawal symptoms through providing some of the effects of nicotine.

The FDA has stated that patients need to tell their health care providers about any psychiatric illness in their family. If there are any current psychiatric illnesses, Chantix may worsen the condition even if it is under control. It may also cause the reoccurrence of old psychiatric illnesses. This is why patients, patients' families, and health care professionals need to remain alert and be vigilant of any behavior or mood changes. The symptoms to look out for are: nervousness, anxiety, depressed mood, tension, thinking about attempting suicide, and unusual behaviors. In many cases, the neuropsychiatric symptoms showed up during the Chantix treatment, but in other cases, the symptoms developed after the course for treatment ceased.

It is crucial for patients taking Chantix to report any changes to their doctor and to also report any strange dreams. Those taking Chantix may also become impaired when operating a vehicle or heavy machinery.

In the meantime, the FDA is going to continue to keep health care professionals updated with any new information that develops regarding the use of Chantix in relation to neuropsychiatric symptoms. This also means possible changes in labeling and other regulatory actions as reviews continue.