FDA Approves Warning Labels For Epilepsy Drugs

摘要

An FDA MedWatch notified healthcare providers that the agency approved labeling revisions about an increased risk of suicidal thoughts and behavior from anti-seizure drugs.rnThe agency also requires development of a medication guide to be given to patients who are prescribed the drugs. The changes, which affect all approved anti-epileptic drugs except those indicated for short-term use, follow a pooled analysis by the FDA of the placebo-controlled clinical studies of 11 anti-convulsant drugs used to treat epilepsy as well as psychiatric disorders and other conditions.