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    Study Links Chantix to Suicide Risk, but FDA Disagrees

    Researchers Say Anti-Smoking Drug Is Linked to Risk of Suicide; FDA and Drugmaker Disagree

    Conflicting Studies on Chantix

    The FDA is standing by its Oct. 24 review of two FDA-sponsored studies that examined hospitalizations for psychiatric reasons in users of Chantix and nicotine-replacement therapy. But the FDA also acknowledges that the studies had significant limitations that made it impossible to rule out an increased risk of suicidal behavior and depression associated with the drug.

    The studies found no evidence of an increase in hospitalizations for psychiatric reasons in Chantix users compared to nicotine patch users.

    In the new analysis, Moore and colleagues from Wake Forest University, Harvard Medical School, and Johns Hopkins University School of Medicine analyzed 3,249 cases of depression and self-injury in Chantix users from 1998 to 2010, as well as users of the antidepressant Zyban, which is approved for smoking cessation, and other nicotine-replacement treatments.

    The cases were reported to the FDA's Adverse Event Reporting System.

    A total of 2,925 of the reported cases involved Chantix (90%), 229 occurred in Zyban users (7%), and 95 (3%) occurred in users of tobacco-replacement treatments.

    FDA Perspective

    In an email, FDA spokeswoman Karen Riley said much of the data used by Moore and colleagues in the new report were not new and had led to the "black box" warning that appears on the drug's labeling. A black box warning is the FDA's most serious warning.

    The warning states that some people have experienced "changes in behavior, hostility, agitation, depressed mood and suicidal thoughts or actions."

    Riley says the researchers failed to consider the impact of media reports linking Chantix to suicidal behaviors as early as 2007, and how that might have influenced people's reporting of similar events after this time.

    Moore denies this, countering that the FDA studies were "fatally flawed" in part because they relied on hospitalization records.

    "Suicide does not result in hospitalization," he says.

    Under the direction of the FDA, Pfizer is conducting a new clinical trial specifically designed to examine depression and other psychiatric events in Chantix users compared to users of Zyban, nicotine replacement, and placebo in people with and without prior psychiatric problems.

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