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The effect of KEPPRA on QTc prolongation was evaluated in a randomizeddouble-blindpositive-controlledmoxifloxacin 400 mgand placebo-controlled crossover study of KEPPRA1000 mg or 5000 mgin 52 healthy subjectsThe upper bound of the 90confidence interval for the largest placebo-adjustedbaseline-corrected QTc was below 10 millisecondsThereforethere was no evidence of significant QTc prolongation in this study.

Anyone considering prescribing KEPPRA or any other AED must balance the risk of suicidal thoughts or behaviors with the risk of untreated illnessEpilepsy and many other illnesses for which AEDs are prescribed are themselves associated with morbidity and mortality and an increased risk of suicidal thoughts and behaviorShould suicidal thoughts and behavior emerge during treatmentthe prescriber needs to consider whether the emergence of these symptoms in any given patient may be related to the illness being treated.

Dosing adjustment for infantschildren and adolescents patients weighing less than 50 kg with impaired renal function:

In controlled clinical studies in adult patients with partial onset seizure studies3.4of adult KEPPRA-treated patients experienced coordination difficultiesreported as either ataxiaabnormal gaitor incoordinationcompared to 1.6of placebo-treated patientsA total of 0.4of patients in controlled clinical studies discontinued KEPPRA treatment due to ataxiacompared to 0of placebo-treated patientsIn 0.7of KEPPRA-treated patients and in 0.2of placebo-treated patientsthe dose was reduced due to coordination difficultieswhile one of the KEPPRA-treated patients was hospitalized due to worsening of pre-existing ataxiaThese events occurred most frequently within the first 4 weeks of treatment.

The use of levetiracetam has been very rarely associated with acute kidney injurywith a time to onset ranging from a few days to several months.

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table 4 incidence of adverse reactions in placebo-controlled, add-on studies in adults experiencing partial onset seizures by body system adverse reactions occurred in at least 1 of immediate-release keppra-treated patients and occurred more frequently than placebo-treated patients .