National Alliance on Mental Illness
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FDA Requires "Black Box" Warnings and Patient Medication Guide for Antidepressant Medications
NAMI News Brief - October 18, 2004
On October 15, 2004, the Food and Drug Administration (FDA) directed manufacturers of antidepressant medications to revise the labeling on their products to include a "black box" warning that notifies healthcare providers and consumers about an increased risk of suicidal thoughts and behaviors in youth being treated with these medications. The FDA also called for closer monitoring of children and adolescents prescribed these medications.
In addition to the "black box" warning, the FDA’s notice also requires that a patient medication guide be given to patients receiving these medications to advise them of the risks and precautions that can be taken to help minimize those risks. The agency is in the process of developing this guide.
These labeling changes are consistent with recommendations made to the FDA during a recent pediatric drug advisory committee meeting.
NAMI applauds the FDA for calling for close monitoring of youth living with depression and for providing families and young consumers with better information about medications for treating depression in youth. Providing both doctors and families with complete information is part of sound clinical practice. Also essential is the need for open discussion about the benefits and risks in prescribing any medications or other courses of treatment.
At the same time, NAMI is concerned that the "black box" warning may lead to primary care providers refusing to prescribe these medications out of fear of liability. Families are often forced to see a primary care provider because of the severe shortage of child psychiatrists. This could worsen the existing crisis in depression and suicide among youth. Therefore, the "black box" warning must be accompanied by increased training and better education for physicians treating children and adolescents with major depression.
The "black box" warning also fails to acknowledge that untreated depression in youth is directly linked to suicide and that antidepressant medications can be effective in treating many adolescents with depression. If families and providers are not warned about the real risk of untreated depression and suicide, they will be hampered in their ability to accurately understand all of the risks.
NAMI has developed an Adolescent Depression Family Guide on treatment options for adolescent depression. If you would like a hard copy please contact Dana Crudo at firstname.lastname@example.org. Families that are concerned about the use of these medications for their loved ones living with depression should talk with their treating provider about the most appropriate course of treatment.