Two Advisory Panels Recommend Removing Warning from Smoking Cessation Pill

Two advisory panels to the U.S. Food and Drug Administration this week recommended removing warnings about suicide from the smoking cessation pill Chantix, according to The Wall Street Journal.

The panels recommended removing a so-called Black Box warning from the medicine. These warnings appear on a prescription drug’s label, and call attention to serious or life-threatening risks.

Europe’s main drug regulating authority earlier this year removed warnings about suicide risks from the Chantix label.

Reuters reports 10 of the 19 panelists recommended removing the warning. They said the benefits of quitting smoking greatly outweighed the potential severe side effects of the drug. Four panelists voted to update the language, while five recommended keeping it.

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    Fr. Jack Kearney

    September 15, 2016 at 1:10 PM

    “In this investigation by the FDA, not only did the agency find financial conflicts of interest of a large number of study researchers, but it also found significant under-reporting of adverse events which was highly correlated with whether a site had a conflicted researcher. This certainly creates the appearance that personal financial conflicts of interest with Pfizer created a bias in the conduct of the study and that the results may therefore be tainted and not trustworthy.” Dr. Michael Siegel, Boston University School of Public Health

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