FDA Panel: No Suicide Warnings on Epilepsy Drugs

Posted: July 10, 2008

BELTSVILLE, MD—The Epilepsy Foundation testified today before a Food and Drug Administration advisory panel reviewing data regarding a potential elevated risk for suicide among people taking AEDs.

The Epilepsy Foundation appreciates the FDA’s review of post-approval data to ensure patient safety. However, the Foundation is concerned that the FDA has not yet considered concurrent mood disorders such as depression and anxiety in the evaluation.

Studies suggest that as much as thirty to fifty percent of people with uncontrolled seizures have clinical depression; and depression left untreated dramatically elevates the risk of suicide.

So is the risk due to AED’s or mood disorders? We believe the FDA should address this question.

Although the FDA advisory panel voted unanimously that 11 antiepileptic drugs (AEDs) being reviewed by the FDA could cause suicidal thoughts and behavior, the 21-member panel also voted 14-out-of-21 not to place a black box warning on AEDs.

It is vital for people with epilepsy to know the following:

1. Never stop taking or change your medication without talking to your doctor. The risk of a breakthrough seizure and the safety consequences is greater than any other concern or risk.
   
   
2. It is normal to feel sad or anxious sometimes; it is just part of living. However, if you find that you are sad for long periods of time and have trouble enjoying life, it could be a serious medical condition called depression. Scientists suspect epilepsy and depression may have a common underlying cause. So talking with your doctor about depression isn’t something to be ashamed of – it is a medical condition and usually can be successfully treated.
   

“We emphasize it is very important we recognize the apparently small additional risk of suicide due to AEDs as compared to the huge risk for not taking needed medications. We ask the FDA to call for more research into co-morbidities as the underlying cause of clinical depression and suicidality,” said Dr. Frank Gilliam, Professor of Neurology at Columbia University in New York City and a member of the national Professional Advisory Board of the Epilepsy Foundation.