On 12/16/08, the US Food & Drug Administration (FDA) issued a rule requiring manufactures of the commonly used AEDs to place a warning about suicide on information material about antiepileptic drugs (AEDs) and to prepare medication guides that discuss this risk. The most severe “black box” warning was not required.

Seizure medicines have long been known to help some people with depression, but also to make others worse. The FDA recently took a look at their database of 199 clinical studies of people taking epilepsy medicines. Their finding was 4 suicides in 27,863 patients taking epilepsy medicines, versus none in patients taking placebo (an inactive pill). They reported 105 people of the 27,863 who did not commit suicide, but had thoughts of suicide. Combined, the risk for suicidal thoughts and behavior was about 0.4% (1 in 250) for those taking epilepsy medications and 0.2% (1 in 500) for those given placebos. The added risk or either suicidal thoughts or behaviors was estimated at 1 case for every 500 people taking AEDs

Drugs specifically covered by the FDA rule, listed alphabetically by generic name, include carbamazepine, clonazepam, clorazepate, divalproex sodium, ethosuximide, ethotoin, felbamate, gabapentin, lacosamide, lamotrigine, levetiracetam, mephenytoin, methosuximide, oxcarbazepine, phenytoin, primidone, topiramate, trimethadione, zonisamide

In the opinion of the editors of epilepsy.com, this is important information because doctors and patients need to know the possible side effects of medicines. But it needs to be put in perspective and certainly is no reason for panic. The 4 suicides in 27,863 is a very small percentage, and it is impossible to be sure the epilepsy drugs were the cause. Depression occurs in about 10% or more of people with epilepsy, even independent of medications. We recommend the following.

• Do not stop your seizure medicine. It could be dangerous.
• If you have symptoms of depression, such as crying and low mood, please discuss them at your clinic visits, so a decision can be made about whether antidepressant medication or referral to a psychotherapist would be useful.
• If you are thinking seriously about suicide, call your medical providers immediately, or call 911.
• For most people, this FDA warning is just something to know, but not a reason to change medicines.

For more information about safety risks associated with epilepsy and AEDs, go here to read more.