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FDA Issues a Public Health Advisory on Suicidal Thoughts and Antiepileptic Drugs

Epilepsy Foundation Professional Advisory Board Members Respond
to The Recent Announcement
from the FDA
on Antiepileptic
Drugs

We at the Epilepsy Foundation feel that the FDA’s recent announcement linking suicidal thoughts with antiepileptic drugs should not cause anyone to become frightened about taking their medications. Reacting to the FDA’s warning by abruptly stopping an antiepileptic medication could be extremely dangerous.

We encourage patients and family members who may have any concerns on the FDA alert to call their doctor, but never to stop their medication on their own.

It is important that people with epilepsy and their families understand that the relationship between epilepsy and suicidal risk is complex and, in most cases, people who develop suicidal ideation or display suicidal behavior are known to have suffered from a history of depression or other psychiatric disorders, as well as to have a family psychiatric history.

Furthermore, there are several studies in the literature that have shown that patients who develop psychiatric symptoms with antiepileptic drugs have a personal or family psychiatric history.

Individuals taking antiepileptic medications can feel reassured by a number of factors. Since depression is relatively common in epilepsy, we don’t know for sure if some individuals had suicidal thoughts that were not in fact caused by the medications.

We need to get much more information about how these statistics were derived. In fact, the American Epilepsy Society has raised serious concerns on the methods used by the FDA in the meta-analysis that led to the alert. Even if medications do raise the risk, this risk is extremely low. The risk of developing this problem after long-term use of a drug is probably especially low if a person has been feeling fine up until now.

The Epilepsy Foundation has always supported the idea that health care providers need to spend time looking for and talking about depression with their epilepsy patients. We hope that the main impact of the recent FDA announcement will be to reinforce the value of good communication between patients and their health care providers.

Page B. Pennell, M.D., Director, Emory Epilepsy Program. Dr. Pennell is Chair of the Epilepsy Foundation’s Professional Advisory Board

Bruce Hermann, Ph.D., Professor of Neurology, University of Wisconsin School of Medicine and Public Health. Dr. Hermann is the immediate past Chair of the Epilepsy Foundation’s Professional Advisory Board.

Andres M. Kanner, M.D. Professor of Neurological Sciences, Rush Medical College Director, Laboratory of Electroencephalography and Video-EEG-Telemetry and Associate Director, Section of Epilepsy and Rush Epilepsy Center, Rush University Medical Center. Dr. Kanner serves on the Quality of Life committee of the Epilepsy Foundation’s Professional Advisory Board.

Alan Ettinger, M.D., Vice-Chairman, Department of Neurology, LongIsland Jewish Medical Center (LIJMC); Professor of Clinical Neurology, Albert Einstein College of Medicine; Director, North Shore–LIJ Comprehensive Epilepsy Centers and Chief Division of EEG andEpilepsy, LIJMC. Dr. Ettinger serves on the Quality of Life committee of the Epilepsy Foundation’s Professional Advisory Board.

Brian Alldredge, PharmD, Professor of Clinical Pharmacy & Neurology; Associate Dean, Academic Affairs, School of Pharmacy, University of California, San Francisco. Dr. Alldredge serves on the Research Council committee of the Epilepsy Foundation’s Professional Advisory Board.

Dec. 18, 2008--The FDA issued an advisory to inform the public of the results of its completed review of clinical trials to see if patients who took antiepileptic drugs had more episodes of suicidal thoughts or behaviors than those who did not take one of these drugs.

Their review included clinical trials for eleven drugs that are a part of a class of drugs (antiepileptic drugs) used to treat epilepsy, psychiatric disorders and other conditions. In these trials, patients who took one of the antiepileptic drugs either alone or as part of a combination had almost twice the risk of having suicidal thoughts or behaviors compared to patients who did not take one of the drugs. This increase in the risk of suicidal thoughts or behavior, according to the FDA, represents the occurrence of about one additional patient experiencing suicidal thinking or behavior for every 530 patients treated with an antiepileptic drug. This increased risk was seen as early as one week after starting treatment and continued for the entire length of treatment time in the studies we reviewed.

In January of 2008, the FDA issued an alert to healthcare professionals communicating the initial results of its analysis of the data. This analysis was also discussed at a public Advisory Committee meeting in July 2008. In keeping with its commitment to provide the public with drug safety information as it becomes available, the FDA issued this public health advisory to inform the public of the final results of its analysis and decision to require that companies who make antiepileptic drugs change the labeling for these products to include Warnings and Information to Patients about the increased risk of suicidal thoughts and behaviors. The companies that manufacture antiepileptic drugs will also be required to develop special patient labeling called a Medication Guide to provide patients with information about the risk of suicidal thoughts and behaviors and the signs and symptoms to look for. After the Medication Guides for antiepileptic drugs become available, patients should receive one each time a prescription is filled.

Patients, caregivers, and healthcare providers should be aware of any signs of worsening depression, any suicidal thoughts or actions and any unusual changes in behavior. Some of the common warning signs for risk of suicidal behavior are:

  • Talking or thinking about wanting to hurt yourself or end your life
  • Becoming preoccupied with death and dying
  • Becoming depressed or having your depression get worse
  • Withdrawing from friends and family
  • Giving away prized possessions

Patients, family members and caregivers should pay close attention to any unusual day-to-day changes in mood, behavior and actions. These changes can happen quickly so it is important to be mindful of any sudden differences.

If you notice any of these signs or if any new and worrisome behaviors occur, contact a healthcare professional immediately. Do not stop taking these medicines without first talking with your healthcare professional. Stopping these medicines suddenly can cause serious problems.

The FDA asks health care professionals and caregivers to report possible cases of suicide, suicidal thoughts and behaviors in patients taking antiepileptic drugs; patients who experience any of the warning signs above and are taking any of these drugs should also report to the FDA through the MedWatch program by phone (1-800-FDA-1088) or via the Internet at http://www.fda.gov/medwatch/index.html.