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PFE) has been lobbying the FDA to back off of the black-box warning on its stop-smoking drug Chantix.
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Real-world quitters, alone with their Chantix pills, or even participating in Pfizer's support plan, will be fighting under entirely different battlefield conditions.
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Over a thousand Chantix-related lawsuits have been assigned to a multidistrict litigation court, which will likely speed the judicial process and result in a faster payout for victims of some of the more serious side effects of the drug.
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In September 2007, a "bizarre" Texas case spurred the FDA to look at adverse-event reports, Rosebraugh said, referring to musician Carter Albrecht, 34, whose girlfriend blamed Chantix for the abnormal violent behavior that led to his shooting death.
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