FDA to urge black box warning for epilepsy drugs

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WASHINGTON (Reuters) - U.S. Food and Drug Administration officials will seek a strong "black box" warning for epilepsy drugs cautioning about the risk of suicidal thoughts and behavior, an agency spokeswoman told Reuters on Monday.

"We are going to ask for a boxed warning on these drugs," said FDA spokeswoman Sandy Walsh.

The agency will ask an advisory panel on Thursday to weigh the proposed warning -- the strongest possible. The panel is set to discuss risks with drugs to treat the disease, which is marked by seizures that can cause involuntary movement or behavior.

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Last month, an FDA analysis concluded epilepsy drugs are associated with a higher risk of suicidal thoughts and behavior. That echoed findings from other data released by the agency earlier this year.

Reuters