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September 18, 2000
The ABCs of Psychiatric Drug Use in Preschoolers
By Irene S. Levine, Ph.D.

illustration: Jason Stout

At elementary schools across the nation, it is not uncommon to see students making a quick lunchtime visit to the nurse's office to take a prescribed mid-day dose of psychiatric medication. But according to an alarming new study, medications such as methylphenidate (known by the trade name Ritalin) are now being liberally prescribed for preschoolers as young as 2.

The study, published in the Journal of the American Medical Association (JAMA) , showed dramatic increases in the use of drugs to deal with behavioral difficulties in children between the ages of 2 and 4. Data from three U.S. regions showed that from from 1991 to 1995, the use of methylphenidate and other stimulants increased more than 200 percent, and that the use of psychiatric drugs such as fluoxetine (Prozac) increased by nearly 150 percent.

Many of these children are being diagnosed with attention deficit hyperactivity disorder, or ADHD, whose symptoms include the inability to sit still, read, or play in groups. To some extent, however, these behaviors are typical in children. Experts fear that this diagnosis, along with the drug treatment, may be becoming a knee-jerk response to the restlessness that is common in young children.

Among those who share this fear is First Lady Hillary Clinton, who is launching an initiative at the end of March to examine the overuse of psychiatric drugs in young children. "Some of these young people have problems that are symptoms of nothing more than childhood or adolescence," the first lady said in an announcement from the White House.

Clinton's new program, which will begin immediately, involves additional warning labels on the drug packages, a scientific study of their use (especially among preschoolers), and a national conference in the fall of 2000 on children's mental health.

sidebar: questions parents need to ask when medication is prescribed

What the study revealed

With funding from the National Institute of Mental Health (NIMH), Julie Magno Zito, M.D., and colleagues at the University of Maryland, Johns Hopkins University, and Kaiser Permanente analyzed data from more than 200,000 children. The investigators looked at patterns of use of three classes of medications: stimulants, antidepressants, and antipsychotics. Additionally, they reviewed data for two specific medications: methylphenidate and clonidine, which is generally used to as an antihypertensive medication but is now frequently prescribed in conjunction with methylphenidate for children with ADHD.

Clonidine does not have FDA approval for treatment of ADHD, and thus is being prescribed "off-label" by pediatricians. Indeed, the use of clonidine in preschoolers is up an amazing 1,500 percent, according to the study. However, there has not been sufficient research on the product to determine the proper dosage or usage with children under 12.

Setting off the alarm

There are few controlled studies on the efficacy and safety of the use of psychiatric medications in young children. Also, the FDA-required product labeling of these psychiatric medications is generally viewed as inadequate, because it fails to provide recommended pediatric dosages. It is not surprising, then, that the study set off an unprecedented wave of concern and conjecture.

In an editorial accompanying the study, Joseph Coyle, M.D., of Harvard Medical School reported on a survey of the prescribing practices of 48 experts in pediatric psychopharmacology. He noted that these experts rarely prescribe psychiatric medications for preschoolers, except in the most severe and intractable cases. Commenting on the study, Dr. Coyle noted that it appears as if these children were "subjected to quick and inexpensive pharmacologic fixes, as opposed to informed multimodal therapy associated with optimal outcomes."

The American Academy of Children and Adolescent Psychiatry agrees that the "quick fix" is not the answer. The group urges more caution, noting that while some very young children can benefit from medication, more attention needs to be paid to appropriate diagnosis and treatment. Scientists at the NIMH cite the need for better information for parents and more research, since so little is yet known about the long-term effects of these medications on a child's developing brain.

When should parents seek help?

Any parent knows that children act out from time to time. Children develop at different rates, and changes in behavior are common, but parents need to seek professional help when problems are severe and persistent, and when they negatively impact family functioning. Examples of such behaviors may include aggression, self-destructive tendencies, frequent injuries, social withdrawal, sleep disturbances, hyperactivity, or the inability to sustain attention.

What parents need to know

  • Behavior in young children is dynamic (changing), and young children lack the verbal skills to fully articulate their needs.
  • Treatment plans must always be made in the context of careful assessment and diagnosis by a trained professional.
  • There are few controlled studies looking at the effects of psychiatric medications on very young children.
  • The consequences of long-term use of psychiatric medications on the brains of children are still unknown.
  • Because of the risks involved, medications usually should not be the first treatment option for a child with a mental disorder.
  • Medications must be viewed as part of a broader treatment strategy that includes family education, behavioral modifications, and other psychotherapeutic interventions.
  • Medications should be considered when the benefits of treatment outweigh the risks of leaving the disorder and its symptoms untreated.
  • Whenever medication is prescribed, its use must be carefully monitored.


Dr. David Fassler, chair of the Council on Children, Adolescents, and their Families of the American Psychiatric Association, called the study "thought-provoking." He commented, "It has helped draw attention to an important issue. At least in the geographical areas and service settings studied, it would appear that more medications are being used, and that they are being used at younger ages. We need to take a close look at exactly what is happening and why.

"However, without the benefit of comprehensive treatment, the underlying psychiatric conditions can also have serious long-term consequences for the child and family. Parents need to be advocates for their children. They need to understand their child's diagnosis and treatment options so they can weigh the risks and benefits and make appropriately informed decisions."

Related links:

White House Press Conference on Medications and Children Fact Sheet -- Treatment of Young Children with Mental Conditions

NIMH Fact Sheet -- Treatment of Children with Mental Disorders

American Academy of Child and Adolescent Psychiatry Fact Sheet -- Psychiatric Medication for Children and Adolescents Part I - How Medications Are Used

American Academy of Child and Adolescent Psychiatry Fact Sheet -- Questions to Ask About Psychiatric Medications for Children and Adolescents