Headache levetiracetam

Geriatric Considerations-Summary Levetiracetam is associated with few drug interactions and low incidence of cognitive impairment. Tremor and headache are more prevalent in older adults as compared to adults < 65 years of age. Hemodialysis reduces plasma concentrations. 

Levetiracetam is a piracetam derivative used in the treatment of refractory partial seizures. In trials it has shown an excellent tolerability profile. The main dose-related adverse effects are sedation, fatigue, and headache. Other possible adverse effects include dizziness, unsteadiness, diplopia, nausea, infection, memory impairment, and disturbances of mood and behavior, although in controlled trials the incidence of most of these was no greater than with placebo (1). 

The efficacy and tolerability of levetiracetam 1-2 g/day as add-on therapy have been studied in 324 patients with refractory partial seizures (9). Levetiracetam did not affect the plasma concentrations of other antiepileptic drugs or alter vital signs or laboratory measurements. The most commonly reported adverse effects in patients taking levetiracetam were weakness, headache, and somnolence. 

The safety of levetiracetam has been assessed in 24 children with uncontrolled partial-onset seizures in an open study (16). The most commonly reported adverse events were headache (33%), infection (33%), anorexia (25%), and somnolence (25%). The adverse events profile of levetiracetam was similar to that seen in adults. Owing to a dispensing error, one patient received an accidental overdose of 71 mg/kg/day, rather than 40 mg/kg/day, during the last 4 weeks of the evaluable phase of the study. No iU effects were reported or observed on examination or laboratory testing, and the patient completed the trial. 

Nervous system The effects of levetiracetam ( = 38), lamotrigine (n = 29), and phenobar-bital (n = 28) have been evaluated in patients with seizures and Alzheimer s disease in a prospective, randomized, three-arm parallel-group, case-control study with a 4-week dosage adjustment and a 12-month evaluation period [199. The adverse reactions were somnolence (5.7%), dizziness (2.8%), headache (2.8%), and weakness (5.7%). Neuropsychological examination showed improvement in attention, shortterm memory, and oral fluency in patients randomized to levetiracetam. 

A 4-year-old previously healthy girl presented with new-onset seizures associated with fevers, headache, and malaise. She developed status epilepticus resistant to intravenous tenzodiaz-epines, fosphenytoin, levetiracetam, valproate, pentobarbital, and ketamine. An initial MRI brain scan was unremarkable. Isoflurane was begun, and an MRI scan 14 days later showed hyperintense T2 signals in the cerebellar vermis and cerebellar hemispheres. The isoflurane concentration was reduced to 0.5% and a further scan after 31 days of isoflurane therapy showed improvement in the signal abnormalities. Her isoflurane exposure was 1382% concentration-hours/1257 MAC-hours. She remained minimally conscious. 

Levetiracetam has been evaluated as add-on therapy in Chinese patients with refractory partial-onset seizures in a multicenter, 4 week titration and 12-week maintenance, double-blind, placebo-controlled trial, in which 206 patients aged 16-70 years were randomized to levetiracetam ( = 103) or placebo ( = 103) [184 ]. Levetiracetam significantly reduced the weekly partial-onset seizure frequency over placebo by 27%. Adverse events, which were of mild-to-moderate intensity, were reported by 65 patients taking levetiracetam and 62 taking placebo. The most common were somnolence (18% levetiracetam and placebo), reduced platelet counts (9.7% versus 9.7%), dizziness (7.8% versus 14%), and headache (3.9% versus 8.7%). 

Observational studies A phase 111 study evaluated the safety and efficacy of levetiracetam in 217 children and adults with primary generalized seizures. The most common adverse effects reported by >10% participants were headache and nasopharyngitis. The most frequent treatment-associated adverse effects were headache (4.6%), dizziness and depression (both 4.1%). Serious adverse effects related to treatment with levetiracetam 4.6% of patients experienced convulsion, atrial fibrillation, epilepsy, depression, psychosis, schizophrenia, suicidal ideation, erythematous rash, and status epilepticus. One patient each discontinued due to the following adverse effects arrhythmia, convulsions, tremor, aggression, depression, psychosis, and exanthem. One patient with worsening of comorbid schizophrenia committed suicide it had been 43 days since he had last taken levetiracetam at the time [87 -]. 

An observational study following 66 adults and children treated with levetiracetam after traumatic brain injury found that the most common adverse events were fatigue, headache, and somnolence [90 ]. Mood scores and number of infections did not differ between the treatment and observation groups. Two of the 66 patients stopped treatment due to somnolence. 

An observational study of 103 pafienfs was performed to assess cognition and behavior in children taking levetiracetam. Ninety-four patients reported adverse events, of which 47 were drug-relafed and included headache (8.7%), irritability (7.8%), aggression (6.8%), fatigue (4.9%), convulsion (3.9%), and abnormal behavior (3.9%) [91 ]. Nineteen (18.5%) patients experienced behavioral problems such as irritability, aggression, or abnormal behavior, which were attributed to levetiracetam. 

Drug formulations The safety and efficacy of extended-release levetiracetam was evaluated in a randomized double-blind study at a dose of either 1000 mg/day or 2000 mg/day the most common adverse events were somnolence (21.9%), headache (19.7%), and convulsion (14.9%) [108 ]. Similar adverse effects have been reported with immediate release formulation of levetiracetam. 

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