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FDA Advisers Don't Back 'Black Box' Warning for Epilepsy Drugs
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Page: << Prev | 1 | 2 Whether the FDA will follow the committee's recommendation against a black box warning will be a matter of discussion, Katz added.
"We take the committee's recommendations very seriously," he said.
The drugs reviewed by the FDA were: Carbamazepine (marketed as Carbatrol, Equetro, Tegretol, Tegretol XR), Felbamate (marketed as Felbatol), Gabapentin (marketed as Neurontin), Lamotrigine (marketed as Lamictal), Levetiracetam (marketed as Keppra), Oxcarbazepine (marketed as Trileptal), Pregabalin (marketed as Lyrica), Tiagabine (marketed as Gabitril), Topiramate (marketed as Topamax), Valproate (marketed as Depakote, Depakote ER, Depakene, Depacon) and Zonisamide (marketed as Zonegran). Some of these drugs are also available as generics.
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According to the FDA, antiepileptic drugs are used to treat epilepsy, bipolar disorder, migraine headaches and other conditions.
In January, the FDA was advising patients not to make any changes in their medication without talking to their doctor.
"Caregivers should pay close attention to changes in mood, behavior and actions," FDA spokeswoman Sandy Walsh said at the time. "They should be aware of the development of these symptoms."
More information
For more on epilepsy, visit the Epilepsy Foundation.
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Copyright © 2008 ScoutNews, LLC. All rights reserved.
Last updated 7/10/2008
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SOURCES: July 10, 2008, teleconference with Russell Katz, M.D., director, division of neurology products, Center
for Drug Evaluation and Research, U.S. Food and Drug Administration, Rockville, Md.; Sandy Walsh, spokeswoman, FDA
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