FDA Requires Warnings About Suicidality Risk With Antiepileptic Drugs
2008-12-24
The US Food and Drug Administration (FDA) will require the manufacturers of antiepileptic drugs to add a warning to their labeling indicating that use of the drugs increases risk for suicidal thoughts and behaviors, according to an FDA Alert issued December 16. A risk evaluation and mitigation strategy, including a medication guide for patients, is also required for each of these drugs.