indications. Age was not a determining factor. The increased risk of suicidal ideation and behavior was observed between 1 and 24 weeks after therapy initiation. However, a longer duration of therapy should not preclude the possibility of an association to the drug since most studies included in the analysis did not continue beyond 24 weeks. Data were analyzed from drugs with adequately designed clinical trials including carbamazepine, felbamate, gabapentin, lamotrigine, levetiracetam, oxcarbazepine, pregabalin, tiagabine, topiramate, valproate, and zonisamide. However, this is considered to be a class effect. Rare cases of suicidal ideation, suicide attempts, and completed suicide have been noted in the manufacturer's labeling. In a controlled clinical trial for the treatment of juvenile myoclonic epilepsy, a dose reduction or discontinuation of levetiracetam occurred in 1.7% of patients due to depressed mood or depression. All patients beginning treatment with anticonvulsants or currently receiving such treatment should be closely monitored for emerging or worsening depression or suicidal thoughts/behavior. Patients and caregivers should be informed of the increased risk of suicidal thoughts and behaviors and should be advised to immediately report the emergence or worsening of depression, the emergence of suicidal thoughts or behavior, thoughts of self-harm, or other unusual changes in mood or behavior. Anticonvulsants should be prescribed in the smallest quantity consistent with good patient management in order to reduce the risk of overdose.
Psychosis, schizophrenia
Levetiracetam may cause behavioral abnormalities and psychotic symptoms; use with caution in patients who have pre-existing psychosis or schizophrenia. Monitor all patients for psychiatric signs and symptoms and consider therapy discontinuation if such symptoms become apparent. In clinical trials, two adult patients (0.3%) developed psychosis within the first week of treatment, leading to hospitalization and treatment discontinuation, with symptom resolution within one to two weeks. Numerous non-psychotic behavioral symptoms, including aggression, agitation, depression, and irritability, have been reported in roughly 13% of adult patients receiving levetiracetam during clinical trials.
Geriatric
There were 347 geratric subjects in clinical studies of levetiracetam that were 65 years of age and older. No overall differences in safety were observed between geriatric and younger adults; however, there were insufficient numbers of geriatric subjects in controlled trials of epilepsy to adequately assess the effectiveness of the drug in older adult patients. There are no pharmacokinetic differences in the geriatric adult compared to younger adults based on age alone. Levetiracetam is known to be substantially excreted by the kidney, and the risk of adverse reactions to this drug may be greater in patients with impaired renal function and care should be taken in dose selection based on the degree of renal impairment. Monitoring of renal function may be useful. According to the Beers Criteria, anticonvulsants are considered potentially inappropriate medications (PIMs) in geriatric patients with a history of falls or fractures and should be avoided in these patient populations, with the exception of treating seizure and mood disorders, since anticonvulsants can produce ataxia, impaired psychomotor function, syncope, and additional falls. The Beers expert pane |
