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    Stop-Smoking Aid Chantix Sparks Safety Concerns

    Researchers Focus on 26 Reports of Chantix and Aggression or Violence; Drugmaker Says No Cause-Effect Evidence Exists

    Chantix: A Closer Look

    Moore and his colleagues gathered information on 78 adverse event reports received by the FDA as well as four other cases reported in clinical trials and three others from published literature. Moore suspects that the 78 cases are just a fraction of existing reports and that some adverse events are unreported.

    The researchers used assessment tools to home in on 26 of the cases to look at more closely. Of these 26:

    • 10 involved assault
    • 9 involved homicidal thoughts
    • 7 cases included other thoughts or acts of aggression or violence

    In a sampling of the cases, the researchers reported that:

    • A 24-year-old woman on the drug woke up her boyfriend and started beating him, then attempted to kill herself.
    • A 21-year-old woman threatened her mother with a shotgun.
    • A 46-year-old man reported he had ''crazy thoughts'' of killing himself and his parents.
    • A 42-year-old man punched a stranger while at a bowling alley.

    The symptoms typically began soon after starting the drug, Moore and his colleagues say, occurring a median of two days after starting.

    They found that when the drug was stopped, the symptoms and other adverse effects resolved in most all cases.

    Moore and his colleague note that nearly 40% of patients on Chantix were also on tranquilizers, antidepressants, or antipsychotic drugs, according to the FDA. The adverse events, the researchers write, may be more or less likely when another medication is also being taken.

    The acts are not likely part of nicotine withdrawal, the researchers say, as they say the effects aren't noticed in other smoking cessation products. The problems may be confined to a small, susceptible group, they say.

    Chantix: Other Views

    The new report shouldn't turn people automatically against the drug, says Serena Tonstad, MD, PhD, a professor of health promotion and education at the Loma Linda University School of Public Health in Loma Linda, Calif., who reviewed the report for WebMD.

    She has served on the advisory board and has been a consultant for Pfizer.

    ''I wouldn't advise people not to try it [Chantix] based on this report," she says. "The benefit of quitting smoking is most important.'' And, she says, the drug has proven effective in helping people to quit.

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