Kids Using More Psych Drugs

By Shawna Vogel,
February 23, 2000

The early 1990s saw a dramatic increase in the use of stimulants, like Ritalin, antidepressants and other antipsychotic drugs in 2- to 4-year-olds, according to a study in the current issue of the Journal of the American Medical Association.

Study shows soaring use of psychiatric drugs.

Julie Magno Zito, a pharmacologist at the University of Maryland in Baltimore and the lead researcher of the study, found that between 1 percent and 1.5 percent of preschoolers in two state Medicaid programs and in one regional HMO were getting these medications, known as psychotropics.

The investigators analyzed drug use during the time period 1991-1995 in approximately 150,000 children in a Midwestern state Medicaid program, a Middle Atlantic Medicaid program, and in an HMO located in the Northwest.

'What I found very disturbing,' said Dr. Joseph T. Coyle, chair of the psychiatry department at Harvard Medical School and author of an editorial accompanying the article, "is that these drugs are being used at ages for which there is absolutely no justification."

Ritalin Most Popular

Indeed Ritalin, which is commonly used to treat attention-deficit/hyperactivity disorder (ADHD), carries a warning against its use in children younger than 6. Ritalin, and most of the drugs in the study are, therefore, being prescribed off-label, meaning that they weren’t originally approved for that use but, according to Food and Drug Administration guidelines, may still be prescribed with caution.

There were hints, even before this study, that psychotropic drug use in young children was on the rise. Zito and her colleagues cited in the article a 1994 report revealing that 3,000 prescriptions for Prozac had been written for children under the age of 1. When the researchers looked at data from the three sources, they found that stimulants, particularly Ritalin, were by far the most popular psychotropic in 2- to 4-year-olds. In 1995, roughly 12 out of every 1,000 young children in the Midwestern state Medicaid program was getting stimulants — a threefold increase from 1991.

Next most popular in the Medicaid programs were antidepressants, like Prozac. Zito found that the use of these drugs doubled during the early 1990s. By 1995, three out of every 1,000 kids in the Midwestern state were on antidepressants.

By 1995, clonidine, a drug commonly used to treat high blood pressure, had passed antidepressants in popularity in the HMO. Clonidine is often used in combination with Ritalin for the treatment of ADHD. This combined treatment, Zito noted, has been associated with questions of safety, including news reports about sudden death.

Who Is Prescribing These Drugs?

As Coyle points out in his editorial, nobody really knows whether a doctor can reliably diagnose either ADHD, mood disorders or schizophrenia in these very young children.

Disturbed by Zito’s analysis, he polled the editorial board of the Journal of Child and Adolescent Psychopharmacology and found "most of the experts said they have not or very rarely use these drugs." Which, he says, raises the issue: If the experts feel that this is inappropriate, then who’s prescribing these drugs?

"It appears," Coyle writes, "that behaviorally disturbed children are now increasingly subjected to quick and inexpensive pharmacological fixes."

Why Kids Get Psychiatric Drugs

BOSTON, Feb. 23 — As rigorous as the Food and Drug Administration can be in having strict requirements for new medication and device use, one group of patients has gone largely unstudied when it comes to drug approval: children.

In December 1998, the FDA tried to change that. The agency mandated that the manufacturers of any drug that could be used in children conduct studies of the safety and effectiveness of that drug for pediatric patients. Such testing would allow it to be approved for use in the very young and to be labeled properly so doctors would know how to dose the drug.

Dr. Jon Abramson, the chair of pediatrics at Wake Forest University in Winston-Salem, N.C., and one of the scientists who led the charge to require drug manufacturers to test their medications in children, says the measure has been effective. Mostly.

That's because once a drug is approved for one age group or condition, it can be used for any person with any condition, as long as a doctor signs off on its use. This type of usage is called "off label," which means a doctor can prescribe a drug for a condition even though the drug is not specifically approved for it. Children are most likely to be treated "off label." In fact, last year, doctors estimated that 70 percent to 80 percent of drugs used on children had not been tested in children.

Because the FDA’s recent mandate won't keep a drug from being approved without pediatric testing doctors can continue to prescribe adult drugs to their young patients.

"None of us want to say 'stop using these drugs' because in many instances we don’t have any alternative," says Abramson. "None of us are going to let a child die of an infection because a drug is off label."

The American Academy of Pediatrics agrees with Abramson, and has released a statement saying that "lack of approval for a specific use should not prevent physicians from prescribing an available drug in the best interests of their patients. The decision to prescribe a drug rests with the physician."

Most recently, the deaths of 11 children after using the adult heartburn drug Propulsid have highlighted the danger of prescribing medications to youngsters without proper testing. Last year, seven infants in Knoxville, Tenn., developed hypertrophic pyloric stenosis, a condition that causes the opening between the stomach and intestines to narrow, after being given a common antibiotic.

And this week, the Journal of the American Medical Association published a report finding that children between the ages of 2 and 4 are increasingly being treated for psychological problems with adult drugs.

"I was rather taken aback when they sent me the paper," says Dr. Joseph T. Coyle, the chair of the psychiatry department at Harvard Medical School, and the author of an editorial accompanying this week's research in JAMA. He added that the long-term effects of these drugs are unknown and it is unclear what effect using psychiatric drugs so early in a child’s life might have on brain development.

But when a child arrives at a doctor's doorstep, sometimes the instinct to cure a disease can override the professional tenet to "first, do no harm."

"Many of the medications that we are finding very helpful in adults have some very clear potential benefits for use in children — but these are drugs that are not approved for use in children," says Dr. Kenneth C. Copeland, a pediatrics professor at Oklahoma University in Oklahoma City. "I'm really struggling — and I think all of us should struggle with this issue."