Pain & Central Nervous System Week via NewsEdge :

2008 APR 28 - (NewsRx.com) -- A new study, 'Levetiracetam and bleeding disorders,' is now available (see also Life Sciences). "Six studies were conducted in healthy male volunteers to evaluate the effect of levetiracetam on bleeding time. In three open-label studies, a single dose of levetiracetam (250, 500, or 1000 mg, respectively) was administered 12 hours after acetylsalicylic acid (aspirin)," researchers in Belgium report.

"Bleeding time increased by 3.5% to 30% relative to baseline, but the effect was not dose-related and not clinically relevant. In a fourth open-label study, levetiracetam was administered twice daily for 4 days, with aspirin administered with the penultimate dose of levetiracetam. The other two studies had a double-blind, placebo-controlled crossover design: levetiracetam or placebo was administered twice daily for 4.5 days and then aspirin was coadministered with the final dose. In the open-label multiple-dose study, the bleeding time increase was more pronounced after repeated levetiracetam doses and ingestion of aspirin than after a single 250-mg dose. However; no clinically relevant change in bleeding time or difference from placebo was observed in the double-blind, crossover studies. Except for two subjects in a crossover study, one of whom received placebo, no absolute bleeding time value was above the normal range of 4-8 minutes. These results indicate that levetiracetam does not produce clinically significant increases in bleeding time in healthy male volunteers," wrote P. Boon and colleagues, Ghent University, Reference Center for Refractory Epilepsy.

The researchers concluded: "Further a review of clinical trials suggests that levetiracetam does not appear to cause clinically significant or relevant hematological adverse events suggestive of underlying hematological disorders."

Boon and colleagues published their study in Acta Neurologica Belgica (Levetiracetam and bleeding disorders. Acta Neurologica Belgica, 2007;107(4):97-102).

For additional information, contact P. Boon, Ghent University Hospital, Dept. of Neurology, Reference Center for Refractory Epilepsy, Belgium.

Publisher contact information for the journal Acta Neurologica Belgica is: Acta Medica Belgica, Avenue Circulaire 138-A, B-1180 Brussels, Belgium.

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