FDA Orders Strong Warnings on Antidepressants Used by Adolescents
Friday, October 15th, 2004Source: U.S. Food and Drug Administration
All antidepressants must carry a “black box” warning to describe the risk and emphasize the need for close monitoring of children and adolescents being treated with antidepressant medications, the U.S. Food and Drug administration said Friday.
The Public Health Advisory is part of a multi-pronged strategy to warn the pubic about the increased risk of suicidal thoughts and behavior in children and teens being treated with antidepressant drugs.
“Today’s actions represent FDA’s conclusions about the increased risk of suicidal thoughts and the necessary actions for physicians prescribing these antidepressant drugs and for the children and adolescents taking them,” said Dr. Lester M. Crawford, acting FDA Commissioner.
In letters issued today, FDA directed the manufacturers of all antidepressant medications to add a “black box” warning that describes the increased risk of suicidality in children and adolescents taking the drugs and notes what uses the drugs have been approved or not approved for in these patients.
Prozac is currently the only medication approved to treat depression in children and adolescents.
A “black box” warning is the most serious warning placed in the labeling of a prescription medication. The new warning language does not prohibit the use of antidepressants in children and adolescents. Rather, it warns of the risk of suicidality and encourages prescribers to balance this risk with clinical need.
The second element of the agency’s strategy is a Patient Medication Guide (MedGuide), FDA-approved user-friendly information for patients. MedGuides are intended to be distributed by the pharmacist with each prescription or refill of a medication. FDA will work with the manufacturers of antidepressant medications to make the MedGuides available as soon as possible.
In addition, 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. “Unit of use” packaging is a method of preparing a medication in an original container, sealed and pre-labeled by the manufacturer, and containing sufficient medication for one normal course of therapy.