When researchers at Wake Forest Baptist Medical Center looked at data in the FDA Adverse Event Reporting System - a database where bad side effects of medications are reported - they noticed something unusual. The researchers found a number of reports that people using Chantix, a drug designed to help people stop smoking, were reportedly engaging in self injury and suffering depression.

The researchers examined more than 3,200 "adverse events' reportedly experienced by users of anti-smoking products. Of that number, more than 2,900 reports of suicidal behavior and depression were related to the use of Chantix; only 229 were reported for Zyban users and only 95 for those using nicotine replacement patches.

That meant Chantix was eight times more likely to be linked to suicidal behavior and depression, according to the researchers, who say the dangers of the drug outweigh the benefits, particularly since only 10 percent of those who use the drug are off nicotine one year later.

This study flies in the face of a recent FDA study which showed no significant difference in psychiatric hospitalizations among nicotine replacement products.

The researchers fault the FDA study, saying it was flawed. The agency itself acknowledged that the study sample was too small to identify "rare" events and only identified events that sent people to the hospital.

Dr. Curt Furberg, professor of Public Health Sciences and one of the primary researchers investigating the dangers of Chantix, point to a number of serious side effects linked to Chantix, including suicide, depression, aggression, sudden blackouts and possible heart problems. He said that not all of these effects would have resulted in hospitalization and therefore they would not have been counted in the FDAs study.

Furberg and his peers were so concerned about the risk of sudden blackouts that he took his findings to the FAA, which banned pilots from taking the drug back in 2008.

Drug manufacturer Pfizer has said that Furberg's analysis is based on inadequate data, that the Adverse Events Reporting System is a self-reporting mechanism in which reports often lack accompanying medical information. The company says it is not an adequate system for establishing the kind of cause and effect relationship the researchers are positing.

Source: Thomson Reuters, "New Study Says Chantix Raises Suicide Risk," by Julie Steenhysen, November 2, 2011.