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3 billion to settle a number of off-label marketing claims which included its marketing of neurontin.

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Gabapentin is secreted into human milk following oral administrationA nursed infant could be exposed to a maximum dose of approximately 1 mg/kg/day of gabapentinBecause the effect on the nursing infant is unknownNEURONTIN should be used in women who are nursing only if the benefits clearly outweigh the risks.

Report any new or worsening symptoms to your doctorsuch asmood or behavior changesanxietypanic attackstrouble sleepingor if you feel impulsiveirritableagitatedhostileaggressiverestlesshyperactivementally or physicallydepressedor have thoughts about suicide or hurting yourself.

Counsel the patienttheir caregiversand families that AEDsincluding NEURONTINmay increase the risk of suicidal thoughts and behaviorAdvise patients of the need to be alert for the emergence or worsening of symptoms of depressionany unusual changes in mood or behavioror the emergence of suicidal thoughtsbehavioror thoughts about self-harmInstruct patients to report behaviors of concern immediately to healthcare providerssee WARNINGS AND PRECAUTIONS

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during the course of premarketing development of neurontin, 8 sudden and unexplained deaths were recorded among a cohort of 2203 epilepsy patients treated 2103 patient-years of exposure with neurontin.

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