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FDA Advisors: Stop the Overuse of Atypical Antipsychotics in Children

During a routine review of the safety of Johnson & Johnson’s atypical antipsychotic Risperdal and Eli Lilly‚Äôs Zyprexa, a panel of experts consulting with the U.S. Food and Drug Administration (FDA) expressed their concern for the increasing amount of prescriptions of these drugs to children, even those under age 12.

Neither these two drugs, nor any other atypical antipsychotic has been approved for prescription to children for most common childhood mental health concerns, namely attention deficit disorder (ADHD) or conduct disorder. Furthermore, there has been zero long-term studies on the effects these drugs may have on a child’s brain development.

The panel of experts is worried that the drugs are being too readily prescribed by doctors unfamiliar with their potency and side effect profile that may be especially harmful to children — substantial weight gain, metabolic disorders and muscular tics that can become permanent if not carefully monitored.

The situation has become alarming:

More than 389,000 children and teenagers were treated last year with Risperdal, one of five popular medicines known as atypical antipsychotics. Of those patients, 240,000 were 12 or younger, according to data presented to the committee. In many cases, the drug was prescribed to treat attention deficit disorders.

Because of the reasons noted above, the panel recommended that the FDA do more to discourage prescriptions of these types of medications in children, especially when the FDA has not approved the use of these drugs for most childhood disorders.

Both drug makers and the FDA basically threw up their hands in response and said, “Hey, we already have strong warnings on these medications, what more can we do?”

Gee, I don’t know, how about issuing an alert to doctors to tell them to stop prescribing these medications off-label for children so young? The data don’t support such prescriptions, and the long-term data is virtually non-existent. Docs (and parents pushing the docs) should stop reaching for every possible new drug to help children when, especially for a disorder like ADHD, there are powerful, fast non-drug treatments available (such as psychotherapy).

Physicians, and especially pediatricians and family docs who are doing a lot of this prescribing, need to just plain stop it. I’m not sure who sold them on the safety and efficacy of these medications in children, but they should only be used as a treatment of last resort, when other, less powerful medications or behavioral treatments have already been tried. Parents should stand up more often and learn a little bit about these medications before okaying them for their children, too. While certainly an option for treatment, they should rarely be the first option for most children.

Read the full story: Use of Antipsychotics in Children Is Criticized

FDA Advisors: Stop the Overuse of Atypical Antipsychotics in Children

John M. Grohol, Psy.D.

Dr. John Grohol is the founder of Psych Central. He is a psychologist, author, researcher, and expert in mental health online, and has been writing about online behavior, mental health and psychology issues since 1995. Dr. Grohol has a Master's degree and doctorate in clinical psychology from Nova Southeastern University. Dr. Grohol sits on the editorial board of the journal Computers in Human Behavior and is a founding board member of the Society for Participatory Medicine. You can learn more about Dr. John Grohol here.

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APA Reference
Grohol, J. (2018). FDA Advisors: Stop the Overuse of Atypical Antipsychotics in Children. Psych Central. Retrieved on October 30, 2020, from
Scientifically Reviewed
Last updated: 8 Jul 2018 (Originally: 19 Nov 2008)
Last reviewed: By a member of our scientific advisory board on 8 Jul 2018
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