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Lloyd I. Sederer, MD Headshot

The FDA and Recommendations for Antipsychotic Medications in Children

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Over a year and a half ago, the NYS Commissioner of Mental Health, Dr. Michael Hogan, and I wrote a state agency advisory entitled Bipolar Disorder in Children: Why Are The Rates Rising?. This week a panel convened by the Federal Drug Administration (FDA) recommended approval of three antipsychotic medications for the treatment of bipolar disorder (and schizophrenia) in children ages 10-17. Because the past 10 years has seen a forty (40!) fold increase in the diagnosis of bipolar disorder in children we are likely about to see dramatic increases in the use of antipsychotic medications in children, a practice that has its problems even though needed at times.

A forty fold increase in a mental disorder in ten years cannot be explained by changes in our genes, or the environment that children live in, including their families. What is happening is that the diagnosis of bipolar disorder is being made far more liberally, perhaps finding a small number of children who had not been previously properly detected but also sweeping in many children whose behaviors are problematic though due to other causes -- and therefore need other approaches than antipsychotic medications. Among these other conditions are ADHD, depression (with agitation), alcohol and drug abuse, conduct disorder, trauma and other expressions of family distress and dysfunction. There are good and simple checklists that your doctor and you can use to help identify bipolar and other conditions more precisely, like the Young Mania Rating Scale (specific to bipolar disorder), the Conners (with parent and teacher rating forms) for hyperactivity and ADHD, the CRAFFT for drug and alcohol abuse, and the PHQ 9 for Adolescents for Depression.

The FDA panel reviewed scientific literature about the safety and efficacy (which means does does it work -- under controlled research conditions) of quetiapine, olanzapine and ziprasidone, all so-called second generation antipsychotic medications to differentiate them from the "first" generation of antipsychotic medications that go back over forty years. The panel endorsed quetiapine above the other two where they raised safety and efficacy concerns. All three of these medications already have approval for use in adults. The FDA is not required to abide by the recommendations of its panel, but it typically does.

Families, youth and doctors reading about the FDA recommendations should be concerned about the accuracy of the diagnosis of bipolar disorder. As a parent or loved one of a child who is identified as having a bipolar illness be sure to insist on a full and clear explanation of the diagnosis and seek a second opinion if you are unsure (as you would if your child had a serious physical illness); even if the diagnosis seems right make sure there is monitoring to see if the diagnosis is accurate over time because symptoms can change and more clearly reveal what is going on.

Equally important is that treatment recommendations for your child, whatever the (correct) diagnosis might be, include education and support for you to more effectively parent, and talking therapy for your child where they learn the triggers of their distressed behaviors and how better to see them coming, avoid them when possible and better manage them when they cannot be eliminated. Effective psychological therapies exist, including cognitive behavioral therapy (where children learn to log their thoughts and consequent emotions) and interpersonal therapy (where they learn how everyday human transactions with family, friends, and others can help or disrupt how they feel); both forms of therapy enable youth to better manage their feelings and their lives. Is your child being helped in these ways or is a singular focus on medications all that is going on?

The human brain is a marvelous organ that is continually changing. The brain of children and adolescents is actively developing and therefore more sensitive to all kinds of things, from medications to experience. There are surely times when medications are needed for an active mental illness; when this is the case, you want your child to have an accurate diagnosis and medication specific for that condition, in minimally effective doses, for only so long as necessary. Remember too, and stress this with your doctor, that well studied talking therapies are safe, effective and remarkably can change the brain too -- without weight gain, diabetes, effects on the heart, muscle tension or abnormal movements. That sounds like a good prescription to me.

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