Why are pediatricians and psychiatrists prescribing powerful antipsychotic medications to children who are under age 5? Especially when no antipsychotic (except Risperdal) has been approved by the U.S. Food and Drug Administration (FDA) in terms of safety or efficacy for use in children. Why is the use of these unapproved-for-children medications so widespread (and growing)?

A new report (PDF) from researchers at the University of South Florida examined prescribing trends for over 19,000 Florida children being prescribed atypical antipsychotics. Philip at Furious Seasons has the full story.

After reviewing the report, however, these were the most disturbing excepts from our point of view (emphasis ours):

The use of antipsychotic medications with children 0-5 [years old] is of concern. The guidelines developed by the program indicate this practice is generally “not recommended” while recognizing that disruptive aggression in autism is now an FDA indicated use. Only 8% of the young children receiving antipsychotic treatment had a diagnosis of autism. ADHD was the most frequently used diagnosis for children 0-5 years on antipsychotic medication. Affective disorder is the next most frequently appearing diagnosis despite Florida’s expert panel’s assertion that the diagnosis is of questionable validity for children under 6 years old. […]

The situation for the 0-5 age group also offers the greatest cause for concern. While the use of antipsychotics with this age group is highly unusual according to the MDTMP guidelines, this group had the smallest percentages of antipsychotic scripts written by psychiatrists. Furthermore, the percentage of antipsychotic scripts for children 0-5 years to total antipsychotic scripts written was highest for pediatricians.

In other words, pediatricians — professionals who are supposed to have the child’s best interests in mind — are some of the worst abusers of antipsychotic prescriptions to children who probably shouldn’t even be diagnosable. (There remains a raging debate amongst professionals whether many of these serious mental disorders can be reliably and appropriately diagnosed in children younger than 5 years old by a mental health professional, much less a primary care physicians specializing in children [not mental health disorders].)

We’re not aware of any antipsychotic carrying FDA approval for ADHD in either adults or children. So why is it being so widely prescribed for this use? Largely because of research studies and literature reviews such as this one (from 2002, which examined 19 studies, 13 of which were for risperidone (Risperdal)) which conclude:

Few firm conclusions can be drawn due to the limitations of the studies; however, there is an indication that risperidone may be effective in reducing hyperactivity, aggression and repetitive behaviors, often without inducing severe adverse reactions.

So even though the researchers admit they can’t draw many firm conclusions, they go ahead and draw one anyway — that Risperdal may be effective for ADHD-like symptoms. Notice all the hemming and hawing? That’s usually a red flag that the data isn’t that strong.

Is any of this prescribing of antipsychotics to children new?

Unfortunately, it’s not. The link goes to a report with similar findings that’s 3 years old. In other words, the message about it being inappropriate to prescribe these powerful medications to such young children isn’t getting through to primary care physicians, pediatricians, and even psychiatrists. See also this article from the New York Times which reports on how the rise of antipsychotics in children has risen 500% from 1993 to 2002.

Disturbing trends indeed.

I am firm believer that there is a reason for the FDA drug-approval process in the U.S. Responsible pharmaceutical companies should work to get additional FDA approvals for uses their drugs are widely being prescribed for, to ensure the public’s safety and confirm the drug’s efficacy in these additional uses. Instead, they all too often rely on smaller, less reliable independent studies to promote such use, because it saves them a lot of time, effort and money to pursue formal FDA approval for additional uses.