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EPILEPSY SOCIETY STATEMENT REGARDING FDA FELBATOL RECOMMENDATIONS

 LANDOVER, Md., Sept. 28 /PRNewswire/ -- The following statement from the American Epilepsy Society concerns the Sept. 27 meeting of the U.S. Food and Drug Administration's Peripheral and Central Nervous System Drugs Committee held at the FDA Center for Drug Evaluation and Research in Rockville, Md. For further information contact Ilo E. Leppik, M.D., president, American Epilepsy Society, 612-525-2400.
 The American Epilepsy Society (AES) strongly supports the FDA Peripheral and Central Nervous System Drugs Committee recommendation that the FDA allow continued use of Felbatol in the treatment of epilepsy.
 Prior to the meeting, there was concern that Felbatol might be withdrawn from sale because it carries a risk profile that is significantly greater than that of other anticonvulsant drugs. The risks go beyond the fact that fatal aplastic anemia has been associated with its use, and include the newly reported potential of liver failure. Hepatitis may be an independent added risk. In addition to CBC blood tests, it is important to monitor liver function as part of the safety battery for this drug.
 Felbatol has been a great benefit for some patients with intractable epilepsy for whom other medications have not worked. Frequent seizures destroy quality of life and, in themselves, pose substantial risk of injury and death. Patients with intractable epilepsy who intend to use Felbatol need to consult with persons having a full knowledge of its potential risks and benefits. The advisory committee recommendation permits patients and physicians to make the difficult personal decisions and allow patients who have benefited greatly from Felbatol to continue to use it.
 The American Epilepsy Society is the organization of professionals concerned with the treatment of biological, clinical and social aspects of epilepsy and seizure disorders. The Society seeks to promote interdisciplinary communication, scientific investigation, and exchange of clinical information about epilepsy.
 -0- 9/28/94
 /CONTACT: Peter Van Haverbeke of the American Epilepsy Society, 301-459-3700/


CO: Epilepsy Foundation of America; U.S. Food and Drug Administration ST: Maryland, District of Columbia IN: MTC SU: EXE

KW-AM -- DC005 -- 8636 09/28/94 09:24 EDT
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Publication:PR Newswire
Date:Sep 28, 1994
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