The FDA’s data analysis of placebo-controlled clinical studies has shown a significant increased risk of suicidality (suicidal behavior and ideation) in patients receiving antiepileptic drugs. Their analysis determined that patients receiving antiepileptic drugs had approximately twice the risk of suicidality (0.43%) compared to patients receiving placebo (0.22%). These risks were first observed in week one of therapy and continued through 24 weeks. Suicidality was higher in epileptic patients than those taking an antiepileptic drug for psychiatric or other conditions.
The eleven drugs analyzed and the brand names under which they are marketed include: carbamazepine (Carbatrol, Equetro, Tegretol, Tegretol XR), felbamate (Felbatol), gabapentin (Neurontin), lamotrigine (Lamictal), levetiracetam (Keppra), oxcarbazepine (Trileptal), pregabalin (Lyrica), tiagabine (Gabitril), topiramate (Topamax), valproate (Depakote, Depakote ER, Depakene, Depacon), and zonisamide (Zonegran).
While only eleven drugs were analyzed, the FDA expects that all antiepileptic drugs share these risks and that labeling changes will be applied broadly to the class. The FDA will be working with the manufacturers to include this new information in the product labeling.
For more information visit www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm100192.htm.