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FDA Warns Epilepsy Drugs May Raise Suicide Risk


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The 11 drugs listed above were included in the studies the FDA analyzed. However, the agency expects that the increased risk of suicidality is present in all antiepileptic drugs and so the labeling changes will be applied to all drugs in the class.

As of now, the FDA is advising patients not to make any changes in their medication without talking to their doctor, Walsh said. "Caregivers should pay close attention to changes in mood, behavior and actions," she said. "They should be aware of the development of these symptoms."

One expert supported the FDA's move to require drug makers to have a warning about the possibility of suicidal behavior on the product label.

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"This is not new, it's something that has been known for a long time," said Epilepsy Foundation Vice President John Schneider.

Schneider noted that some people with epilepsy may be clinically depressed, so it's hard to tell whether it's the medication or the condition that is causing the suicidal behavior.

"Patients need to know their medications," Schneider said. "The goal should be no seizures and no side effects."

Another expert finds the association between antiepileptic medicines and suicide surprising.

"We do know that the incidence of comorbid affective [emotional] disorders and risk of suicide is higher in patients with epilepsy compared with the general population, and therefore it is not surprising to see higher incidence of suicide in the FDA report," said Dr. Gholam Motamedi, director of the Epilepsy Service at Georgetown University Hospital, in Washington, D.C.

However, the data showing a raised risk of suicide with medication use is surprising, Motamedi said.

"It's also surprising to attribute suicide to the antiepileptic drugs, per se, because a good number of these drugs are used in psychiatry for their positive effects on mood and depression," Motamedi said. "Nevertheless, this emphasizes the importance of screening for signs and symptoms of depression and suicidal tendencies in the epilepsy clinics."

More information

For more on epilepsy, visit the Epilepsy Foundation.

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Copyright © 2008 ScoutNews, LLC. All rights reserved.
Last updated 2/1/2008

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SOURCES: Sandy Walsh, spokeswoman, U.S. Food and Drug Administration, Rockville, Md.; John Schneider, vice president, Epilepsy Foundation, Landover, Md.; Gholam Motamedi, M.D., associate professor, neurology, and director, Epilepsy Service, Georgetown University Hospital, Washington, D.C.


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