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Table 4Adverse Reactions that Resulted in Discontinuation or Dose Reduction in Placebo-Controlled Studies in Adult Patients Experiencing Partial Onset Seizures.

Available data in children did not suggest impact on growth and pubertyHoweverlong term effects on learningintelligencegrowthendocrine functionpuberty and childbearing potential in children remain unknown.

Patientstheir caregiversand families should be informed that AEDs increase the risk of suicidal thoughts and behavior and should be advised of the need to be alert for the emergence or worsening of the signs and symptoms of depressionany unusual changes in mood or behavioror the emergence of suicidal thoughtsbehavioror thoughts about selfharmBehaviors of concern should be reported immediately to healthcare providers.

In controlled adult clinical studies15of patients receiving KEPPRA and 12receiving placebo either discontinued or had a dose reduction as a result of an adverse reactionTable 4 lists the most common1adverse reactions that resulted in discontinuation or dose reduction and that occurred more frequently in KEPPRA-treated patients than in placebo-treated patients.

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