Increasing numbers of preschoolers are being given stimulants and anti-depressants to treat behavioral problems, raising questions about the drugs' impact on the developing brain, a new study says.
The medications are commonly used to treat hyperactivity and depression in older children and adults. Though their use among children younger than 5 remains relatively rare, researchers said the upward trend in that age group is worrisome because none of the drugs has been tested on children so young.
"It's a fair question to ask what are the outcomes of treatment in the community when we use these drugs in very young children," said Julie Magno Zito, a professor at the University of Maryland School of Pharmacy.
"A 4-year-old has yet to evolve a fully developed personality -- all that is going to come as he matures," said Zito, who led the study appearing in today's Journal of the American Medical Association. "You want to assure yourself that you are not impeding those processes at the same time that you are showing [the child] sits still in the classroom better, or in this case, in day care."
The researchers looked at the records of 200,000 children enrolled in three health plans in 1991 to 1995. The plans weren't identified but were described as Midwestern and mid-Atlantic region Medicaid programs, and a Northwestern health maintenance organization.
Scientists found sharp increases in the use of stimulants, drugs such as Ritalin that are widely prescribed to curb attention deficit hyperactivity disorder in older children; of anti-depressants; and of Clonidine, a blood pressure medication that is sometimes given to children on stimulants to help them sleep.
Zito said the records did not include the diagnoses of children taking the drugs or the dosages.
In an accompanying editorial, Dr. Joseph Coyle of the Harvard Medical School raised the possibility that doctors are prescribing the drugs as "quick and inexpensive pharmacologic fixes" because of constraints imposed by health plans. In the past, he said, a child might have been more likely to be evaluated by a team of specialists.
"These disturbing prescription practices suggest a growing crisis in mental health services to children and demand more thorough investigation," Coyle said.
The numbers of children on these drugs are not huge. In 1995, about nine of every 1,000 children in the mid-Atlantic region Medicaid program were on stimulants, primarily Ritalin; 1.6 children per 1,000 were on anti-depressants; and 1.4 per 1,000 were on Clonidine.
But the rates rose sharply over the five years. In the same Medicaid program, rates for stimulants and anti-depressants almost dou- bled. The rate for Clonidine was almost seven times higher.
Ritalin has been studied extensively in older children, but not in preschoolers. The other drugs were tested only in adults, leading to "off-label" uses in teen-agers and pre-adolescents. Prescribing them for troubled preschoolers started to take root in the early 1990s, Zito said.
"We don't know how long kids stay on these medications, and what doses they are getting," she said. "The package insert says nothing about dosing in children under 6 [years old], the length of time they are in treatment or the degree of satisfaction."
Dr. Mark Riddle, chief of child and adolescent psychiatry at the Johns Hopkins Children's Center, said the results don't surprise him because increasing numbers of children are coming to his clinic already medicated. Riddle runs a clinic that is beginning controlled trials of psychotropic medications among children.
It is impossible at this point to say whether the drugs are prescribed appropriately, he said. Perhaps in the past, he said, preschoolers with severe behavioral problems weren't getting medication, only to end up struggling in school and having conflicts with teachers and other children.
Riddle said doctors should be attuned to possible side effects, including sleep loss and irritability with stimulants; irritability and sedation with Clonidine; and agitation with anti-depressants.
Dr. Alan Davick, a Baltimore County pediatrician who specializes in behavioral disorders, said he considers the drugs a last resort but doesn't hesitate to use them when children are in severe distress. Stimulants, he said, are sometimes warranted when a young child cannot bond with parents, speak in coherent sentences or refrain from impulsive, dangerous behavior.
"The fact that these medications are not labeled for children under a certain age is not only not unique but is par for the course in pediatrics," he said. The same has been true for some antibiotics, anti-convulsants and asthma drugs, he said.