FDA Strengthens Safeguards for Children Treated with Antidepressants

The Food and Drug Administration (FDA) issued a Public Health Advisory announcing a multi-pronged strategy to warn the public about the increased risk of suicidal thoughts and behavior ("suicidality") in children and adolescents being treated with antidepressant medications. Manufacturers are directed to add a “black box” warning to the health professional labeling of all antidepressant medications. The second element of the agency’s strategy is a Patient Medication Guide (MedGuide), FDA-approved user-friendly information for patients, which are distributed by the pharmacist with each prescription or refill of a medication. Additionally, FDA intends to work with manufacturers to implement “Unit of Use” packaging for all antidepressants as a means of ensuring that patients receive a MedGuide with every prescription or refill.