FDA Drug Safety Communication

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FDA Date: 12/16/08

Depakote (divalproex sodium) FDA Drug Safety Communication

Information for Healthcare Professionals: Suicidal Behavior and Ideation and Antiepileptic Drugs

The FDA has completed its analysis of reports of suicidality (suicidal behavior or ideation [thoughts]) from placebo-controlled clinical trials of drugs used to treat epilepsy, 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.

All patients who are currently taking or starting on any antiepileptic drug for any indication should be monitored for notable changes in behavior that could indicate the emergence or worsening of suicidal thoughts or behavior or depression.

The following is a list of antiepileptic drugs* included in the FDA analyses that led to this labeling revision:

Carbamazepine (marketed as Carbatrol, Equetro, Tegretol, Tegretol XR)

Divalproex sodium (marketed as Depakote, Depakote ER)

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)

Zonisamide (marketed as Zonegran)

*Some of these drugs are also available in generic form.

This information reflects the current analysis of data available to FDA concerning this drug. FDA intends to update this communication when additional information or analyses become available.

View the full FDA Drug Safety Communication on FDA.gov