Food and Drug Administration
U.S. Department of Health and Human Services
Public Health Service 5600 Fishers Lane Rockville, MD 20857
FDA Talk Papers are prepared by the Press Office to guide FDA personnel in responding with consistency and accuracy to questions from the public on subjects of current interest. Talk Papers are subject to change as more information becomes available.
T99-54 Print Media: 301-827-6242 December 1, 1999 Consumer Inquiries: 888-INFO-FDA
About 2 million people in the United States are affected by epilepsy, a neurological condition that can produce brief disturbances in the brain's electrical function. These disturbances, known as seizures, occur when nerves in the brain fire spontaneously, causing symptoms ranging from shaking of a single arm to loss of consciousness and generalized spasms. Partial onset seizures occur when abnormal electrical activity only involves one area of the brain.
Keppra, chemically unrelated to most currently marketed antiepileptics, provides a new treatment option for these patients. Unlike most epilepsy drugs, Keppra as well as Neurontin (gabapentin), another approved epilepsy drug, do not interfere with the body’s metabolism of other epilepsy drugs. Studies have indicated that because the drug is not metabolized through the liver, it is unlikely to cause interactions with other epilepsy drugs or commonly used drugs such as oral contraceptives. In addition, no serious blood or liver related toxicities were seen in clinical trials of more than 1300 patients with epilepsy.
Three multi-center clinical studies in about 900 patients demonstrated Keppra’s effectiveness as adjunctive therapy for adults who experience partial onset seizures.
Patients should be advised that Keppra may cause dizziness and somnolence (sleepiness). The new drug will be manufactured and distributed by UCB Pharma, Inc., Smyrna, Ga.
About two dozen different drugs are available for the treatment of epilepsy. Gabatril (tiagabine) was the latest, approved for epilepsy in l997.