PharmExec Blog

Antiepileptic Drugs To List Suicidality Warnings

Of the 199 trials, 66 (33%) had at least one suicidal behavior or ideation event (source: FDA)

Makers of antiepileptic are now required to include a warning that the drugs could boost thoughts of suicide, according to an FDA statement released yesterday. Drugmakers also must create a risk mitigation strategy for each drug and handout a pamphlet to patients spelling out the potential adverse reactions.

“Patients being treated with antiepileptic drugs for any indication should be monitored for the emergence or worsening of depression, suicidal thoughts or behavior, or any unusual changes in mood or behavior,” stated Russell Katz, director of the division of neurology products at CDER, in a release. “Patients who are currently taking an antiepileptic medicine should not make any treatment changes without talking to their health care professional.”

In clinical trials, four patients committed suicide as opposed to none taking the placebo. However, the committee chose not to upgrade the labeling to a stronger boxed warning, instead recommending that the labeling be followed with increased education.

Below is a list of the drugs mandated to add the new warnings:
Carbamazepine (marketed as Carbatrol, Equetro, Tegretol, Tegretol XR)
Clonazepam (marketed as Klonopin)
Clorazepate (marketed as Tranxene)
Divalproex sodium (marketed as Depakote, Depakote ER, Depakene)
Ethosuximide (marketed as Zarontin)
Ethotoin (marketed as Peganone)
Felbamate (marketed as Felbatol)
Gabapentin (marketed as Neurontin)
Lamotrigine (marketed as Lamictal)
Lacosamide (marketed as Vimpat)
Levetiracetam (marketed as Keppra)
Mephenytoin (marketed as Mesantoin)
Methosuximide (marketed as Celontin)
Oxcarbazepine (marketed as Trileptal) Phenytoin (marketed as Dilantin Suspension)
Pregabalin (marketed as Lyrica)
Primidone (marketed as Mysoline)
Tiagabine (marketed as Gabitril)
Topiramate (marketed as Topamax)
Trimethadione (marketed as Tridione)
Zonisamide (marketed as Zonegran)
Some of these medications are also available as generics.

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