In what was seen as a foregone conclusion in February 2008. a black box warning on epilepsy drugs is now far from reality.
The U.S. Food and Drug Administration advisory panel agreed that the drugs may increase the risk of suicide but felt the risk was not sufficient enough to merit a black box warning and risk patients avoiding the drug therapy.
The vote by the advisory panel stood at 14 against the warning, 4 in favor and 3 abstaining. However, the panel did recommend that a medication guide be sent to doctors detailing the possible suicide risk associated with the epilepsy medications.
The 11 drugs on the list to potentially have the warning bring a total of over $10 billion annually.
- 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)
Zonisamide (marketed as Zonegran)
The narrow escape from black box warnings is not set in stone due to the fact that the FDA usually follows its panel's advice but is not required to.
Epilepsy Drugs to get FDA Warning
[Source:FiercePharma]
» Topamax Gets 6 Month Pediatric Exclusivity Extension from PharmaGazette
The U.S. Food and Drug Administration has granted a six month pediatric exclusivity to Ortho-McNeil-Janssen Pharmaceuticals for its drug Topamax for use in patients aged 1 to 24 months with partial onset seizures.The extension does not give the drug FD... [Read More]
Tracked on: August 2, 2008 5:56 PM | Permalink to Trackback