Antiepileptics to get suicidality warning

FDA said it will require that the labels of antiepileptic drugs be updated to warn of increased risk of suicidality. The agency also will require the makers of the drugs to submit a risk evaluation and mitigation strategy (REMS), including a medication guide, for each product. The alert reflects recommendations from a July FDA advisory committee, which voted 17-4 that labels of all epilepsy drugs should include a medication guide that warns about increased risk of suicidality (See BioCentury Extra, Thursday, July 10, 2008). ...