“Whitewashing a Black Box Warning: The Chantix Story That Didn’t get Told”

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“The decision to remove the Chantix black box warning had its roots in a study known as the EAGLES trial, which was mandated by the FDA and designed to establish the neuropsychiatric safety and efficacy of varenicline, buproprion and nicotine patches in smokers with or without psychiatric disorders. Pfizer maintained that this trial confirmed Chantix’s superiority and safety, yet the trial was highly criticized by some observers. Those objections received little attention from some news outlets that covered the label update.”

Close-up on the words 'Possible side effects' on an information sheet supplied with medicine.
Close-up on the words ‘Possible side effects’ on an information sheet supplied with medicine.

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4 COMMENTS

  1. Is this the whole article? There doesn’t seem to be a link out.

    Anyway, in reference to a prior recent comment on the FDA, I was amazed to hear that anyone would have serious doubts about the new appointment for head of the agency. Republican or Democrat, he or she could hardly be worse than the present ‘team’.

    I DO think we were better off in a world before this agency. People still looked for advice before taking a drug. There were still doctors. There just wasn’t a money-seeking totalitarian partnership of business interests blocking and obfuscating the facts necessary for free choice.

  2. I had the common symptoms of antidepressant discontinuation syndrome, which resulted from being abruptly taken off of the ineffective so called “safe smoking cessation med,” Wellbutrin, misdiagnosed as “bipolar,” so personally I question research conclusions funded by Pfizer and GlaxoSmithKline.