"On Nov. 20, 2007, FDA issued an Early Communication to the public and health care providers that the agency was evaluating postmarketing adverse event reports on Chantix related to changes in behavior, agitation, depressed mood, suicidal ideation, and actual suicidal behavior.
As the agency's review of the adverse event reports proceeds, it appears increasingly likely that there may be an association between Chantix and serious neuropsychiatric symptoms. As a result, FDA has requested that Pfizer, the manufacturer of Chantix, elevate the prominence of this safety information to the warnings and precautions section of the Chantix prescribing information, or labeling. In addition, FDA is working with Pfizer to finalize a Medication Guide for patients. This is an example of FDA working with drug manufacturers throughout products' lifecycles to keep health care professionals and patients informed of new and emerging safety data."
No, this is an example of an agency that has been unfairly beaten to a pulp and is now trying to cover it's behind.
Here's an idea: how about a science-based approach to the issue of smoking and suicide before we jump to any conclusions about broad effects based on "appearances"...
So for instance:
"Cigarette smoking is associated with a higher risk for suicide and attempted suicide, but psychopathological or biological explanations for this association have not been explored. Lower serotonin function and impulsive/aggressive traits are associated with suicidal acts, including completed suicide. The authors hypothesized that the relationship that may exist between cigarette smoking and suicidal behavior may be associated with lower serotonin function and the presence of impulsive/aggressive traits."
Rihmer Z, DÃ¶me P, Gonda X, Kiss HG, KovÃ¡cs D, Seregi K, Teleki Z.
Cigarette smoking and suicide attempts in psychiatric outpatients in Hungary.
Neuropsychopharmacol Hung. 2007 Jun;9(2):63-7.
"The presence of associations between prior smoking and subsequent suicidality, in concert with the lack of associations between prior suicidality and subsequent smoking suggests the existence of an independent pathway from smoking to suicidality."
Bronisch T, HÃ¶fler M, Lieb R.
Smoking predicts suicidality: Findings from a prospective community study.
J Affect Disord. 2007 Nov 14; [Epub ahead of print]
"Current daily smoking, but not past smoking, predicted the subsequent occurrence of suicidal thoughts or attempt, independent of prior depression and substance use disorders (adjusted odds ratio, 1.82; 95% confidence interval, 1.22-2.69). Additionally, current daily smoking, but not past smoking, predicted the subsequent occurrence of suicidal thoughts or attempt, adjusting for suicidal predisposition, indicated by prior suicidality, and controlling for prior psychiatric disorders (adjusted odds ratio, 1.74; 95% confidence interval, 1.17-2.54)."
Am J Psychiatry. 2003 Apr;160(4):773-9.
Cigarette smoking, suicidal behavior, and serotonin function in major psychiatric disorders.
Malone KM, Waternaux C, Haas GL, Cooper TB, Li S, Mann JJ.
Could Chantix be associated with increased suicidal behavior? Of course. But the key is to focus on what biological pathways would be implicated and identify people most at risk based on their illness, age, family history, etc. I hope Pfizer agrees. And I hope the FDA does too. I am not so sure about about tort lawyers, Senator Grassley, Public Citizen, George Soros or others who regularly dump on the drugwonks blog. They are too giddy about the presence of more pharma blood in the water and the opportunity perhaps to push another drug off the market even if it means -- because of the link between smoking and suicides -- more people dying. I would be delighted to be proven wrong on this latter score.