Smoking Cessation Drug Chantix Under Review by the FDA for Safety

The drug Varenicline (marketed as Chantix) that is commonly prescribed to aid patients in quitting smoking, is being reviewed by the Food and Drug Administration (FDA) for safety. The decision to review Chantix for safety was made after the FDA received several reports of suicidal thoughts, erratic behavior and aggressive behavior in patients taking Chantix.

The drug Chantix is only under review to investigate reports of suicidal and erratic behavior. No determination has been made at this point that validates the claims of Chantix being responsible for these behaviors in patients using the drug. The FDA is not recommending that medical professionals discontinue prescribing Chantix. When the FDA is done with their study of the drug Chantix, they will release their conclusions and recommendations to the public.

The FDA is looking over reports from Pfizer, Inc., the company who manufactures Chantix. There have been reports of suicidal thoughts and behavior in patients using Chantix, but it is not clear if Chantix was the cause of the behavior. The suicidal thoughts and behavior happened in the reported patients within days to weeks of taking Chantix. It is difficult to evaluate if Chantix is the cause because suicidal thoughts and behavior are common in patients who are quitting smoking, due to nicotine withdrawal. In addition, nicotine withdrawal can trigger or worsen existing psychological illness. It must be noted though, that some of the patients taking Chantix with reported suicidal thoughts and behavior did not have pre-existing psychological illness and had not quit smoking.

There has been a publicized case of a patient taking Chantix to quit smoking, who experienced erratic behavior that led to their death. It is not clear at this time if the erratic behavior was due to the patient taking Chantix. The patient had other factors including alcohol consumption that might explain the erratic behavior.

Drowsiness associated with the use of Chantix has also been reported. The drowsiness might affect a patient's ability to drive or operate machinery. The FDA is currently reviewing cases to determine if Chantix does cause drowsiness.

In the meantime, the FDA has made the following recommendations:

Healthcare professionals should monitor patients taking Chantix for behavior and mood changes.

Patients taking 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 quitting smoking with Chantix may affect them.

The FDA is asking that medical professionals and patients report any side effects from the use of the drug Chantix at the FDA web site or by calling the FDA at (800) 332-1088.

Source:
www.fda.gov/cder/drug/early_comm/varenicline.htm