“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.”
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