Warning Labels on Anti-Depressants for Teenagers

Share it now

Warnings on Anti-Depressants

No doubt you have seen recent news headlines about a federal panel that recommended to the FDA that anti-depressant medications carry the strongest possible warning label for use in children and teenagers. This recommendation to the FDA shook the medical community, especially those who work with depressed young people, and now the FDA does mandate that antidepressants used to treat adolescent depression carry the “black box” warning label.

The warning label reads:

Suicidality in Children and Adolescents

Antidepressants increase the risk of suicidal thinking and behavior (suicidality) in children and adolescents with major depressive disorder (MDD) and other psychiatric disorders. Anyone considering the use of [Drug Name] or any other antidepressant in a child or adolescent must balance this risk with the clinical need. Patients who are started on therapy should be observed closely for clinical worsening, suicidality, or unusual changes in behavior. Families and caregivers should be advised of the need for close observation and communication with the prescriber. [Drug Name] is not approved for use in pediatric patients except for patients with [Any approved pediatric claims here]. (See Warnings and Precautions: Pediatric Use)

Pooled analyses of short-term (4 to 16 weeks) placebo-controlled trials of nine antidepressant drugs (SSRIs and others) in children and adolescents with MDD, obsessive compulsive disorder (OCD), or other psychiatric disorders (a total of 24 trials involving over 4400 patients) have revealed a greater risk of adverse events representing suicidal thinking or behavior (suicidality) during the first few months of treatment in those receiving antidepressants. The average risk of such events on drug was 4%, twice the placebo risk of 2%. No suicides occurred in these trials.

The biggest problem from the treatment community's point of view was not the recommendation for the warning label, but the way that the media portrayed the panel's recommendation. The panel reported that 2% to 4% of children and teens that were given anti-depressants for the treatment of depression had suicidal thoughts, or made suicidal attempts of one kind or another. None of the 4,000 children and teens studied committed suicide.

What the media did not report well is the fact that 10% to 15% of children and teens with depression that receive no treatment will commit suicide. These 10% to 15% will not just think about it, but will actually kill themselves.

So what are we to do? If the media had their way it seems that no teens with depression would receive anti-depressants. As a result the suicide rate for those who could be using the medication would rise from nearly zero percent to about fifteen percent, which is the suicide rate for depressed teens who are untreated.

While there actually are young people, and adults, who have become suicidal only after beginning treatment with an anti-depressant, and some have in fact gone on to take their own lives, which is absolutely tragic and heart-breaking, so is the fact that untreated depression is potentially a fatal disease. As many as fifteen out of one hundred young people with depression take their own lives unless they receive treatment. These young people should be allowed to receive a treatment that will lower the suicide rate dramatically, and without any stigma attached to it by the media.

With proper diagnosis and treatment a depressed teen, or adult, can be greatly helped. If someone close to you is suffering from depression, first please understand that depression is a very emotionally painful condition. Please take the situation seriously.

If you know of a teen whose behaviors have changed to look like what has been described above, let the parents know that there is help available, and encourage the family to seek help from a professional.

Back to Teenagers and ADHD index

Share it now