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The FDA has been examining for some time the data supposedly showing an increased risk of suicidality in patients enrolled in clinical trials of epilepsy drugs.
We looked at that data last month and were left scratching our heads.
Today, in anticipation of an Advisory Committee meeting later this week, the FDA has posted on its website documents officially proposing adding a Black Box suicidality warning to epilepsy drugs.
The news, a link to the FDA documents, and the back story are all available at Pharmalot.