Levetiracetam safety profiles and tolerability in epilepsy patients.
This review discusses the safety and tolerability of levetiracetam, as presented by the available literature, with attention paid to special populations. In Phase II/III trials, the adverse effects occurring more commonly in the treatment groups versus the placebo group were; somnolence (14.8 versus 8.4%), asthenia (14.7 versus 9.1%), infection (primarily common cold) (13.4 versus 7.5%), and dizziness (8.8 versus 4.1%). Adverse events usually appear within the first month after treatment initiation, are not dose-dependent, are mostly mild-to-moderate, generally resolve without medication withdrawal, and are transient when the medication is stopped. No significant changes in haematology and chemistry profiles or weight occurred. Hypersensitivity reactions were rare and no idiosyncratic event has been reported. Open-label studies have added patient data with other epileptic syndromes and from a wider patient pool, such as children and patients with prior psychiatric history. These studies have supported initial safety findings, but have reported increased behavioural adverse events in children and patients with a history of prior behavioural problems. Levetiracetam is proving to be safe and well-tolerated. So far, it appears to have a favourable safety profile in special populations, such as children, the elderly, and patients with hepatic dysfunction. Preliminary data in pregnancy are promising, but more data are needed on the impact of levetiracetam on the developing fetus and pharmacokinetic alterations caused in pregnancy. Adjustments in dosing are required for decreases in renal clearance.
Briggs
Deborah E
DE
Department of Neurology, Hospital of the University of Pennsylvania, 3400 Spruce Street, Philadelphia, PA 19104-4283, USA.
French
Jacqueline A
JA
D000014:Abnormalities, Drug-Induced / Q000209:etiology; D000293:Adolescent; D000328:Adult; D000367:Age Factors; D000368:Aged; D000818:Animals; D000927:Anticonvulsants / Q000009:adverse effects* / Q000494:pharmacology / Q000627:therapeutic use; D001247:Asthenia / Q000139:chemically induced; D015519:Bone Density / Q000187:drug effects; D002648:Child; D002653:Child Behavior Disorders / Q000139:chemically induced / Q000150:complications; D002986:Clinical Trials as Topic; D006970:Disorders of Excessive Somnolence / Q000139:chemically induced; D004244:Dizziness / Q000139:chemically induced; D004353:Drug Evaluation, Preclinical; D004827:Epilepsy / Q000188:drug therapy*; D005260:Female; D006261:Headache / Q000139:chemically induced; D006801:Humans; D007239:Infections / Q000209:etiology; D007674:Kidney Diseases / Q000150:complications; D000077287:Levetiracetam; D008107:Liver Diseases / Q000150:complications; D008297:Male; D001523:Mental Disorders / Q000139:chemically induced / Q000150:complications; D051379:Mice; D008875:Middle Aged; D010342:Patient Acceptance of Health Care; D010889:Piracetam / Q000009:adverse effects* / Q000031:analogs & derivatives* / Q000494:pharmacology / Q000627:therapeutic use; D011247:Pregnancy; D011248:Pregnancy Complications / Q000188:drug therapy
D000927:Anticonvulsants; D000077287:Levetiracetam; D010889:Piracetam