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October 8, 2014 Margaret A. Hamburg Commissioner Food and Drug Administration through Division of Dockets Management
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Document Date: 2014-10-08 12:00:45

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File Size: 440,90 KB

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Rockville / /

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Pfizer / /

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France / United States / Canada / Australia / New Zealand / /

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USD / /

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Product Issues / /

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United States District Court / /

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replacement products / /

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hallucination / Short Description Type CHANTIX Aggression/Violence Case Series Case series Aggression/Violence PRR Study Disproportionality analysis Suicidality/Depression / psychosis/psychotic disorders / suicidal/self injury / hallucinations / nausea / blackouts / injury / reduced injuries / mental illness / psychotic hallucinations / visual hallucinations / depression / paranoia / alleged injury / Suicidality/Depression / injuries / Depression Depression / /

MedicalTreatment

nicotine replacement therapy / medication error / /

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OSE / /

Organization

Federal Aviation Administration / FDA OSE / Food and Drug Administration / United States District Court / Institute for Safe Medication Practices / FDA office of Surveillance and Epidemiology / FDA’s OSE / Department of Defense / National Physicians Alliance / office of Surveillence / Food and Drug Administration Department of Health and Human Services / National Center for Health Research / Department of Transportation / /

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Petition / /

Position

federal judge / Commissioner / physician / judge / /

Product

Venlafaxine / Safe Medication / CHANTIX / nicotine / Occupations Part / meta analyses / taking Chantix / consciousness/vision / motor control / /

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Maryland / /

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Consumer Reports / /

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