A report by the Institute For Safe Medicine Practices found that Chantix was the subject of 1001 adverse event reports in the first quarter of 2008 – the most attributed to any medication during that time period.

In May, researchers at the same Institute reported that Chantix had been the subject of   224 reports of potential heart-rhythm disturbances, 372 reports of possible movement disorders and 544 reports of likely glycemic problems, including diabetes. At that time, there were also reports of a dozen traffic accidents linked to Chantix.  That study prompted the Department of Transportation, the Federal Aviation Administration and the Department of Defense to restrict the use of Chantix.

Now, those same researchers have said Chantix needs to carry stronger warnings about its potential risks of accidental injury and death. According to the Institutes latest report, duringthe first three months of 2008, Chantix adverse event reports to theFood & Drug Administration (FDA) included 50 deaths, 52 cases that may have involved various kinds of blackouts, and 15 adverse events that were linked to road traffic accidents.

Since its approval in 2006, Chantix has been linked to a variety of serious side effects, incluing suicide, suicidal behavior and dpression. In November 2007, the FDA issued an “Early Communication” that stated its preliminary assessment revealed many of the cases reflected new-onset of depressed mood, suicidal ideation, and changes in emotion and behavior within days to weeks of initiating Chantix treatment.

In February, the FDA said “it appears increasingly likely that there may be an association between Chantix and serious neuropsychiatric symptoms.”  At that time, Pfizer elevated  the prominence of safety information regarding suicidal thoughts and other psychiatric problems to the warnings and precautions section of the Chantix prescribing information, or labeling.