Research Finds Chantix is Unsuitable for First-Line Smoking Cessation

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Research published in the November 2 issue of PLoS ONE concluded varenicline (Chantix) is unsuitable for first line use for smoking cessation because of its poor safety profile. Results showed a -substantially increased risk of reported depression or suicidal behavior compared to other smoking cessation treatments. Ninety-percent of all reported suicides related to smoking-cessation drugs since 1988 implicated Chantix despite the fact that it was only on the market 4 of the 13 years of the study. In addition, it was eight times more likely to result in a reported case of suicidal behavior or depression than nicotine replacement products and was associated with more suicidal behavior than any other smoking-cessation drug on the U.S. market. The researchers analyzed 3,249 case reports of serious injury from the FDA’s Adverse Event Reporting System between 1998 and September, 2010 for self-injurious behavior or depression related to Chantix, Zyban (bupropion) and nicotine replacement products. For suicidal behavior and depression 90% (2,925 cases) were related to Chantix, 7% (229) related to Zyban, and 3% (95) were related to nicotine replacement products. The researchers also said there are other safety issues with Chantix found by other researchers. They concluded “We agree with the recommendation of the U.S., Veterans Administration (VA) that varenicline should be prescribed only after failure of nicotine replacement , bupropion or a combination.” They further said “We
strongly recommend that the FDA should revise the black box warning to say what the study and the FDA ‘s own data shows–that varenicline has higher risks for suicidal behavior and depression than other smoking-cessation treatments.” .

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