FDA Requires Suicide Warnings On Epilepsy Drugs

Chrissie Cole

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The FDA is requiring makers of widely used epilepsy drugs to add a warning about the increased risk of suicidal thoughts and behaviors to the products’ prescribing labeling and information.

The action – not a “black box” warning – applies to all antiepileptic medications, even those that are used to treat some psychiatric disorders and migraines, as well as other health conditions.

The following drugs will receive 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 those drugs are also sold generically.

An epileptic has recurring seizures that are caused by irregular electrical impulses in the brain. When the cause of epileptic seizures cannot be determined, certain anti-seizure drugs may be prescribed to control their occurrence.

In 2007, more than 10 million Americans took FDA-approved epilepsy drugs. #