Antiepileptic Drugs Double Risk for Suicidality

FDA Mandates Labeling that Warns of Risk of Suicidal Behavior

The U.S. Food and Drug Administration today announced it will require the manufacturers of antiepileptic drugs to add to these products' prescribing information, or labeling, a warning that their use increases risk of suicidal thoughts and behaviors (suicidality). The action includes all antiepileptic drugs including those used to treat psychiatric disorders, migraine headaches and other conditions, as well as epilepsy.

The FDA's actions are based on the agency's review of 199 clinical trials of 11 antiepileptic drugs which showed that patients receiving antiepileptic drugs had almost twice the risk of suicidal behavior or thoughts (0.43 percent) compared to patients receiving a placebo (0.24 percent). This difference was about one additional case of suicidal thoughts or behaviors for every 500 patients treated with antiepileptic drugs instead of placebo.

"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," said Russell Katz, M.D., director of the Division of Neurology Products in the FDA's Center for Drug Evaluation and Research. " Patients who are currently taking an antiepileptic medicine should not make any treatment changes without talking to their health care professional."

The following antiepileptic drugs are required to add warnings about the risk of suicidality:

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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Published on Dec-16-08