Pfizer Strengthens Suicide Warning On Chantix Label

January 19 , 2008 | Pharmalot.com

The drugmaker updates the label to reflect ongoing concern that the anti-smoking drug is connected to suicidal thoughts and behavior.

You may call last November, the FDA began reviewing cases of suicidal thoughts and aggressive and erratic behavior in Chantix patients that were received from Pfizer, along with a number of reports from the media and internet sites. At the time, the agency wrote on its web site that “a preliminary assessment reveals that many of the cases reflect new-onset of depressed mood, suicidal ideation and changes in emotion and behavior within days to weeks of taking Chantix.”

And so today Pfizer says its updated label includes a warning “that patients who are attempting to quit smoking with Chantix should be observed for serious neuropsychiatric symptoms, including changes in behavior, agitation, depressed mood, suicidal ideation and suicidal behavior.” No figures were immediately available on cases reported.

A notable example, however, that drew national attention to Chantix was the case of Carter Albrecht. While in a drunken rage, the Texas musician banged on the door of a homeowner, who feared an intruder, and shot and killed the young man. Although Albrecht was later found to have tested for a high level of alcohol, he’d also begun taking Chantix, the smoking-cessation drug, a week earlier and complained of vivid dreams. Hallucinations are noted as only a rare psychiatric disorder, but “Chantix dreams” were cited by Albrecht’s family and girlfriend as possibly contributing to his outburst.

The FDA, meanwhile, had asked Pfizer for on additional cases that may be similar. The agency is “currently evaluating the material Pfizer submitted in response” as well reports of drowsiness in people taking Chantix who had difficulty driving or operating machinery. We are awaiting an update from Pfizer concerning the info provided to the agency.