DoD MEDICATION SAFETY NOTICE

Issue 3 – June 2, 2009

Suicidality and Antiepileptic Drugs

On May 5, 2009, the Food and Drug Administration (FDA) updated Information for
Healthcare Professionals on Suicidality and Antiepileptic Drugs (AED). On April 23,
2009, the FDA approved updated labeling for all AEDs to address increased risk of
suicidal thoughts and behavior. Labeling changes will be made by the pharmaceutical
manufacturers by the end of 2009. These drugs include:
Carbatrol, Celontin, Depakene, Depakote ER, Depakote sprinkles, Depakote
tablets, Dilantin, Equetro, Felbatol, Gabitril, Keppra, Keppra XR, Klonopin,
Lamictal, Lyrica, Mysoline, Neurontin, Peganone, Stavzor, Tegretol,
Tegretol XR, Topamax, Tranxene, Tridione, Trileptal, Zarontin, Zonegran,
and generics.

The association, if any, of suicides in the Military Health System with antiepileptic
(anticonvulsant) drugs, is unclear. However, the risk of associated use of these drugs
with suicide, as well as the fact that changes to medication guides may not be made on all
drugs until the end of 2009, led to this Medication Safety Notice being generated.

Quoting the FDA:

• Epilepsy and other illnesses for which AEDs are prescribed are associated
with an increased risk of suicidal thoughts and behavior.
• Should suicidal thoughts or behavior emerge during treatment with AEDs, the
prescriber should consider whether these symptoms may be related to the
illness being treated.
• 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.

Prepared by:
Geoffrey Rake, M.D.
Director, DoD Patient Safety Center
June 2, 2009