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UPDATED: Fri, 02/29/2008 - 10:11am
Breaking News - FDA Alert for AEDs
Table of Contents
- FDA Alert for AEDs - Breaking News Feature
- FDA Alert - Articles in the News
- Experts Comment on FDA Alert
- Frequently Asked Questions about AEDs and Depression
According to an FDA Alert issued on January 31, 2008, based on the FDA's analysis of 199 studies comparing an antiepileptic drug (AED) with a placebo, patients receiving AEDs rarely displayed suicidal behavior or ideation (about 4 out of every 1,000 patients). Because this was more than was seen in patients receiving placebo (about 2 out of every 1,000 patients), the FDA has provided the following information for patients, family members, and caregivers:
- Taking antiepileptic medicines may increase the risk of having suicidal thoughts or actions;
- Do not make any changes to the medication regimen without first talking with the responsible healthcare professional;
- Pay close attention to any day-to-day changes in mood, behavior and actions. These changes can happen very quickly so it is important to be mindful of any sudden differences.
- Be aware of common warning signs that might be a signal for risk of suicide. Some of these are:
- Talking or thinking about wanting to hurt yourself or end your life
- Withdrawing from friends and family
- Becoming depressed or having your depression get worse
- Becoming preoccupied with death and dying
- Giving away prized possessions
We again urge patients and families to contact your doctor before stopping an epilepsy medication because this may lead to seizures. Let your doctor help you determine whether your current problems indicate a need to change treatment. We will have further information as it develops./ The Editors
For more information go to: http://www.fda.gov/cder/drug/InfoSheets/HCP/antiepilepticsHCP.htm
For more information go to: http://www.fda.gov/cder/drug/InfoSheets/HCP/antiepilepticsHCP.htm
- FDA Warns Epilepsy Drugs May Raise Suicide Risk
U.S. News & World Report - Washington,DC,USA
... Gabapentin (marketed as Neurontin), Lamotrigine (marketed as Lamictal), Levetiracetam (marketed as Keppra), Oxcarbazepine (marketed as Trileptal), ... - FDA Warns Of Suicide Risk With Epilepsy Drugs
CNNMoney.com - USA
In a statement, Pfizer said it hasn't identified any evidence an increased risk of suicide-related events in Lyrica or Neurontin based on a review of ... - FDA Finds Increase in Suicide Symptoms for Patients Using Seizure ...
New York Times - United States
A spokesman for Pfizer, Jack Cox, said its review of Neurontin and Lyrica found “no evidence of an increased risk of suicide-related events in either ... - US warns of suicidal actions with epilepsy drugs
Guardian Unlimited - UK
The medicines include Pfizer Inc's Neurontin and Lyrica, GlaxoSmithKline Plc's Lamictal, Abbott Laboratories Inc's Depakote and Johnson & Johnson's Topamax. ... - US warns of suicidal actions with epilepsy drugs
Reuters - USA
The Food and Drug Administration said it analyzed studies of 11 epilepsy drugs including Pfizer Inc's Neurontin, ...
Frequently Asked Questions about AEDs and Depression
Updated on February 13th, 2008.