The News:
On July 10, 2008, two FDA Advisory Committees voted not to require that 11 epilepsy drugs carry a black box warning about the risk of suicide ideation and behavior. The drugs being considered for this warning were carbamazepine, divalproex sodium, felbamate, gabapentin, lamotrigine, levetiracetam, oxcarbazepine, pregabalin, tiagabine, topiramate, and zonisamide. (Source - MedPage Today)
IDIS Related Question:
What black box warnings, if any, do these 11 drugs currently carry?
IDIS Search Strategy:
Drug(s): "CARBAMAZEPINE 28122007" or "VALPROIC ACID 28122015" or "FELBAMATE 28122022" or "GABAPENTIN 28122020" or "LAMOTRIGINE 28122024" or "LEVETIRACETAM 28122040" or "OXCARBAZEPINE 28122011" or "PREGABALIN 28122016" or "TIAGABINE 28122034" or "TOPIRAMATE 28122035" or "ZONISAMIDE 28122004"
Descriptor(s): "FDA BLACK BOX WARNING 165"
IDIS Results:
Carbamazepine: 1) serious dermatologic reactions and HLA-B*1502 allele 2) aplastic anemia (IDIS article 592789)
Divalproex sodium: 1) hepatotoxicity and 2) teratogenicity (IDIS article 561301)
Felbamate: aplastic anemia (IDIS article 557094)
Lamotrigine: serious rashes requiring hospitalization and discontinuation of treatment (IDIS article 559571)
Friday, July 11, 2008
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