title: Safety profile of levetiracetam.
abstract: Levetiracetam was approved in November 1999 as add-on therapy for the treatment of partial-onset seizures in adults (age 16 years and older). This review focuses on recently published data from four well-controlled studies in patients with partial-onset seizures with or without secondary generalization. When levetiracetam was given along with other antiepileptic drugs (AEDs), the most frequently reported adverse events were central nervous system related. Adverse events were usually mild to moderate in intensity, with the most frequently reported events occurring predominantly during the first 4 weeks of treatment. No relationship was apparent between the dose of levetiracetam and the most commonly reported adverse events in well-controlled clinical trials within the recommended dose range of 1,000-3,000 mg/day. Levetiracetam is a Pregnancy Category C drug. Overall, when used in combination with other AEDs, levetiracetam was generally well tolerated as add-on treatment for partial-onset seizures.
authors.affiliation: Comprehensive Epilepsy Center, Cornell Medical Center, New York, New York 10021, USA. clharden@mail.med.cornell.edu
authors.forename: C
authors.initials: C
authors.lastname: Harden
mesh_terms: D000014:Abnormalities, Drug-Induced / Q000453:epidemiology; D000927:Anticonvulsants / Q000009:adverse effects* / Q000506:poisoning / Q000627:therapeutic use; D002493:Central Nervous System Diseases / Q000139:chemically induced / Q000453:epidemiology; D018849:Controlled Clinical Trials as Topic / Q000706:statistics & numerical data; D003645:Death, Sudden / Q000453:epidemiology / Q000209:etiology; D004305:Dose-Response Relationship, Drug; D004334:Drug Administration Schedule; D017277:Drug Approval; D062787:Drug Overdose / Q000453:epidemiology; D004359:Drug Therapy, Combination; D004828:Epilepsies, Partial / Q000188:drug therapy; D004827:Epilepsy / Q000188:drug therapy*; D005260:Female; D006801:Humans; D015994:Incidence; D007231:Infant, Newborn; D000077287:Levetiracetam; D008297:Male; D010889:Piracetam / Q000009:adverse effects* / Q000031:analogs & derivatives* / Q000506:poisoning / Q000627:therapeutic use; D010919:Placebos; D011247:Pregnancy
chemical_list: D000927:Anticonvulsants; D010919:Placebos; D000077287:Levetiracetam; D010889:Piracetam