Are too many kids taking antipsychotic drugs?

Certain antipsychotic drugs have been approved by the FDA to treat schizophrenia and bipolar disorder in adolescents and teens, as well as extreme irritability in children 5 and older with autism who could be a danger to themselves and others. (See the table below for a summary).

But the majority of kids prescribed antipsychotic drugs don’t take them for one of those reasons. Schizophrenia is rarely diagnosed until adulthood, for example. Bipolar disorder is estimated to affect less than 3 percent of teens, according to the National Institute of Mental Health, but the exact prevalence is unknown because of its difficulty to diagnose in children. That’s partly because the symptoms are less clear and may overlap with other conditions such as ADHD. And while about one in 110 children have some form of autistic disorder, only about 30 percent are affected by the aggressive impulse behavior antipsychotic drugs have been approved to treat.

Table 1. Antipsychotic Medications and Their Approved Uses

Over the last decade or so, doctors have increasingly prescribed the drugs for “off-label” uses, particularly in ADHD and disruptive behavior disorder, a broad diagnosis that encompasses a range of behaviors from attacking other children to temper tantrums and defying authority.

Those disorders affect a much larger pool of children. About 10 percent of kids aged 3 to 17 are affected by either behavior problems or ADHD.

Increasingly, kids are prescribed antipsychotic medications at their pediatrician’s office, rather than by a psychiatrist. The number of prescriptions for the drugs written by pediatricians has increased steadily over the last several years and is up nearly 25 percent since 2006.

“What started out as a treatment with some level of evidence for a small sub-group of youth with significant development disabilities, for example, has been extended to cognitively normal kids without any strong evidence,” Rubin said.

Two studies provide a window on just how much things have changed. In the first, researchers looked at prescribing practices from 2005 to 2009 and those of a decade earlier. Results, published online Aug. 6, 2012, by the Archives of General Psychiatry showed that antipsychotic use increased about 85 percent in children and adolescents—at a much higher rate than in adults—and that the drugs are now used very differently in younger patients. For example, in adults, doctors prescribe antipsychotic drugs mostly for bipolar disorder, depression, or schizophrenia and more often to women; in children and adolescents, the drugs are most commonly prescribed to treat disruptive behavior disorder in boys.

Another analysis found that antipsychotic prescriptions for children age 2 to 5 doubled between 2001 and 2007. Most of the children were 4- and 5-year-old boys, with ADHD and disruptive behavior disorder among the most frequent diagnoses.

Use of all psychiatric drugs has increased in children, not just antipsychotic drugs. One reason is a growing awareness of mental health problems in kids and an honest desire to treat them. But the system is not always set up to provide the best care.

For one thing, an approach that combines nondrug measures such as parent training and cognitive behavior therapy with medication if necessary may work best. But many kids taking antipsychotic drugs have never seen a mental health professional. “Use is really high among kids in the Medicaid system where decent non-drug services may be difficult to find,” says Rubin, who also points out that even kids with private insurance often don’t have coverage for psychiatric care or counseling.

And it doesn’t help that drug companies might overhype the benefits of the drugs while playing down the risks.

Antipsychotics have become huge moneymakers for the drug industry. In 2003, annual U.S. sales of the drugs were estimated at $2.8 billion; by 2011, that number had risen to $18.2 billion. That huge growth was driven in part by one company—Janssen Pharmaceuticals— and its aggressive promotion of off-label uses in children and elderly patients, relying on marketing tactics that according to the federal government, crossed legal and ethical lines.

In November, Janssen Pharmaceuticals and two other subsidiaries of the behemoth drug manufacturer Johnson & Johnson agreed to pay more than $2.2 billion to settle criminal and civil claims stemming from deceptive marketing of the antipsychotics risperidone (Risperdal) and other products. According to claims made by the U.S. Department of Justice, the companies marketed two antipsychotics for uses that were never proved safe and effective using tactics that allegedly included downplaying serious risks and paying kickbacks to physicians and pharmacies for prescribing and promoting the drugs.

There’s been little official research into the use of antipsychotic drugs in kids, particularly off-label uses of the drugs. But, in effect, widespread off-label use of the drugs means that many kids are involved in a sort of large, poorly controlled experiment. That has left a lot of questions, even some basic ones, unanswered:

Do they help? Even for approved uses, the evidence is limited to a few short-term studies; it’s still unclear how well the drugs work and whether they remain effective over the long-term. All total, studies of the drugs have involved fewer than 3,000 children, most followed for eight weeks or less.

Are they safe? Newer antipsychotic drugs are turning out to carry more risk than initially thought. “The atypical versions were thought to be safer (than older antipsychotic drugs), but we are seeing a different set of side effects,”  Bellonci said.

One of the most common side effects is weight gain. Studies lasting six to eight weeks show that children and teens can gain an average of 2 to 9 pounds, depending on the drug, and current research suggests that weight gain may continue as long as children take the drugs. In addition, some antipsychotic drugs can adversely affect cholesterol and increase blood sugar levels and their risk of type-2 diabetes.

Although the newer antipsychotic medications used commonly today are less likely to cause movement disorders than older versions of the drugs, some studies have found that kids taking certain drugs are still at slightly higher risk of abnormal body movements, including muscle twitches, tremors, and spasms than those receiving a placebo.

What happens when drugs are combined? Even less is known about what happens when kids take two or more of the drugs at the same time, something that doctors often prescribe. For example, in one study of a large Medicaid program, 7 percent to 8 percent of children and adolescents treated with antipsychotic drugs received two or more of the drugs for an average of about six months. And in the preschool study cited earlier, nearly 80 percent of children prescribed antipsychotic drugs were taking one or more additional psychiatric drugs.

How do they work? The exact mechanism is not well understood. Scientists know that antipsychotic drugs affect neurotransmitters, brain chemicals that play important roles in behavior and cognition, as well as sleep, mood, attention, memory and learning. This might be how the drugs reduce psychotic symptoms, such as hallucinations, delusions, disorganized thinking, and agitation as well as the tendency to hurt oneself or others.

Although there may be a place for limited off-label use of antipsychotic drugs in children, the group of kids who could benefit needs to be better defined and the drugs should be more carefully managed than they often are today.

“In the end, what I’m bothered most by is those who would say we have to do it this way because we don’t have enough mental-health resources,” said Helen Egger, M.D., Chief of Child and Family Mental Health and Developmental Neuroscience in the Department of Psychiatry and Behavioral Sciences at Duke University Medical Center in Durham, North Carolina. “That’s not good enough. The answers on how best to use these drugs will come from instituting evidence-based standards of care.”

Eggers and others advocate for a multifaceted approach to behavioral, emotional, and developmental issues, in which medications, if used at all, would comprise only one part of treatment. While there is no cookie-cutter formula for families dealing with complex and often very difficult issues, following steps outlined below can help people navigate the health care system and get the best possible care for their child.

See our Best Buy Drugs report for detailed information on the use of antipsychotic medications in children, including a comprehensive evaluation of the research and analysis of the risks and benefits of the drugs.