A skeptical take on quit-smoking drug Chantix

Soon after Pfizer Inc.'s quit-smoking pill Chantix debuted in 2006, the U.S. Food and Drug Administration began receiving reports of severe psychiatric disturbances in people taking it, including suicides, other kinds of self-harm, and violence.  The troubling link led to prominent warnings on the Chantix labeling.

Thomas Moore, a drug safety and policy expert at the Institute for Safe Medication Practices (ISMP) in Horsham, has been at the forefront of efforts to investigate the risks of Chantix and warn consumers about them.

Because of the risks, Moore believes Chantix should not be a "first-line" – that is, first choice – treatment for smoking cessation. But numerous studies have suggested that quit rates are better with Chantix  -- alone or in combination with nicotine replacement therapy -- than nicotine therapy alone.  And many public health officials argue that smoking is such a harmful addiction that  quitting is worth the risk of serious side effects.

Now, the first clinical trial to conduct a head-to-head comparison of the nicotine patch, Chantix, or the patch plus nicotine lozenges finds they work about the same.  At a year, 21 percent of patch cessation pharmacotherapies." In Moore's view, "the safety reporting in this study was weak."

In October 2014, the FDA rejected Pfizer's request to remove Chantix's "black box" package warning about adverse neuropsychological effects. That same month, ISMP and other nonprofit consumer medical organizations petitioned the FDA to toughen Chantix label warnings and advise against use by pilots, police and others in potentially hazardous professions; the FDA still has not decided.

users were smoke-free, compared to 19 percent with Chantix, and 20 percent with the patch-lozenge combo.  Chantix users, however, had more frequent adverse effects, including vivid dreams, insomnia, nausea, constipation, sleepiness and indigestion.

For Moore, the new study bolsters the ISMP position. "This drug, because of its risks and benefits, is not suitable for first-line use," he said, noting that the study was funded by the government, not Pfizer.  "If you can see a safer alternative, it seems to me it would be unwise to prescribe the less-safe drug."

The authors of the new study, who work at the University of Wisconsin School of Medicine's Center for Tobacco Research and Intervention, do not discuss the balance of risks and benefits, except to say their results "raise questions about the current relative effectiveness of intense smoking 

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