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Because clinical trials are conducted under widely varying conditionsadverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
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.
KEPPRA may cause somnolence and fatiguePatients should be monitored for these signs and symptoms and advised not to drive or operate machinery until they have gained sufficient experience on KEPPRA to gauge whether it adversely affects their ability to drive or operate machinery.
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