The FDA has completed its analysis of reports of suicidality (suicidal behavior or ideation [thoughts]) from placebo-controlled clinical trials of neuronal stabilizing agents (anticonvulsants) used to treat epilepsy, Migraine disease, psychiatric disorders, and other conditions. Based on the outcome of this review, FDA is requiring that all manufacturers of drugs in this class include a Warning in their labeling and develop a Medication Guide to be provided to patients prescribed these drugs to inform them of the risks of suicidal thoughts or actions.
In the FDA's analysis of 199 clinical trials, patients receiving neuronal stabilizing agents had approximately twice the risk of suicidal behavior or ideation (0.43%) compared to patients receiving placebo (0.22%). The increased risk of suicidal behavior and suicidal ideation was observed as early as one week after starting the neuronal stabilizing agent and continued through 24 weeks. The results were generally consistent among the eleven drugs. The relative risk for suicidality was higher in patients with epilepsy compared to patients who were given one of the drugs in the class for other conditions.
Healthcare professionals should closely monitor all patients currently taking or starting any of these medications for notable changes in behavior that could indicate the emergence or worsening of suicidal thoughts or behavior or depression.
The drugs included in the analyses include (some of these drugs are also available in generic form):
- 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)
- zonisamide (Zonegran)
Although the 11 drugs listed above were the ones included in the analysis, FDA expects that the increased risk of suicidality is shared by all neuronal stabilizing agents and anticipates that the class labeling changes will be applied broadly.