The New York Times

Wednesday, February 23, 2000

Sharp Rise Found in Psychiatric Drugs for the Very Young

By ERICA GOODE

In a finding that medical experts called "troubling" and "very surprising," researchers reported today that the number of preschoolers taking stimulants, antidepressants and other psychiatric drugs rose drastically from 1991 to 1995.

n the study, researchers found that the use of stimulants -- most commonly methylphenidate, the generic form of Ritalin -- increased twofold to threefold for children, ages 2 through 4, who were enrolled in two state Medicaid programs and in a health maintenance organization in the Northwest.

Stimulants are commonly used to treat attention disorders.

The number of preschoolers receiving prescriptions for antidepressants doubled in the Medicaid programs.

And the use of clonidine, a blood pressure drug gaining popularity as a treatment for insomnia associated with attention disorders, also jumped.

Although researchers have known for some time that such drugs are increasingly being prescribed for older children, the study, which appears in today's issue of the Journal of the American Medical Association, is the first to document an increase among children younger than 5. Reseachers suspect that the increase has continued.

"This seems to support the anecdotes that more U.S. children are receiving a diagnosis and treatment for attention deficit hyperactivity disorder in the late 1990's than ever before," said Dr. Julie Magno Zito, an associate professor of pharmacy and medicine at the University of Maryland and lead author of the study.

The research was conducted by analyzing prescription records in the five-year period of more than 200,000 preschoolers in the two Medicaid programs and the H.M.O.

Previous studies had shown significant increases in the use of stimulants and antidepressants to treat children between the ages of 5 and 19. In a smaller study of Medicaid enrollees in Michigan in 1998, researchers found that of 223 children younger than 4 who were diagnosed with attention deficit hyperactivity disorder, 57 percent received at least one drug to treat the condition.

Though the total number of very young children in the latest study who received prescriptions for the drugs was small, 1 percent to 1.5 percent, the increase is disturbing, the researchers said, because research on the safety and efficacy of the medications, scant for older children, is virtually nonexistent for preschoolers.

"We don't have any benchmarks to know if this is or is not a problem," Dr. Zito said.

Dr. Zito and her colleagues noted that the findings may not apply to other all medical settings. But she said she suspects that the use of stimulants to treat attention disorders is even more prevalent among children from higher-income families.

Dr. Steven Hyman, director of the National Institute of Mental Health, said that he was "more than shocked" by the findings.

The use of psychiatric drugs in young children, he said, is "an area of enormous concern," and one that Dr. Hyman has made a priority in the institute's funding of research.

At the same time, Dr. Hyman said, he is sympathetic "to the intense need to do something for children who really are so terribly sick that other means cannot control their behavior."

Because the researchers did not track the diagnoses given to the children or the training of the professionals who prescribed the drugs, the reasons for the increases were not clear.

But experts speculated that the reasons might include the reluctance of H.M.O.'s and subsidized medical care programs to pay for counseling or other treatments that do not involve drugs, the pressures from parents and schools to diagnose children with attention disorders, the rise of drugs as the preferred mode of treatment and the fact that most prescriptions in subsidized settings are written by primary care doctors rather than specialists.

Few of the drugs, Dr. Zito and other experts pointed out, are approved by the Food and Drug Administration for treating children of preschool age. The package insert for methylphenidate, for example, carries a warning against prescribing the drug to children under 6.

While the prescription of drugs by physicians for purposes not approved by the F.D.A., called off-label prescribing, is both legal and common in the treatment of older patients, the practice raises more difficult issues in young children.

When a physician prescribes a drug off-label for a child, Dr. Zito said, parents "should be aware that they are entering an area of uncertainty."

The symptoms of emotional or behavioral problems displayed by children younger than 5 may be different from those exhibited by older children, and diagnosis of such conditions in preschoolers is at best iffy. As Dr. Joseph Coyle, chairman of psychiatry at Harvard Medical School, commented, the normal behavior of many 2-year-olds and 3-year-olds looks a lot like attention deficit hyperactivity disorder.

Dr. Zito said, "It is not really clear that children this young could meet the diagnostic criteria for either attention deficit hyperactivity disorder or depression, and those are the probable diagnoses given to justify the use of stimulants, clonidine and antidepressants."

Even more worrisome, experts said, is the fact that little is known about the effects of antidepressants, stimulants and other psychoactive drugs on brain development. Studies in animals indicate that the brain chemicals that are targeted by some such drugs play an important role in the proliferation of nerve cells in the brain.

"These interventions are occurring at a critical time in brain development," said Dr. Coyle, who wrote an editorial accompanying the report, "and we don't know what consequences are."

In the study, methylphenidate was by far the most popular stimulant prescribed for preschoolers, accounting for 90 percent of the prescriptions. In the Midwestern Medicaid group, 11.1 of every 1,000 children age 2 to 5 were prescribed methylphenidate in 1995.

In the H.M.O. and in a mid-Atlantic Medicaid group, the number of girls receiving prescriptions for stimulants increased more in the five years than the number of boys, researchers found, suggesting that girls are increasingly being diagnosed with attention disorders.

"The message is that girls are more likely than in the past to be getting medicated," Dr. Zito said, "where attention deficit disorder used to be more of little boys' disorder."

Among antidepressants, the older generation of "tricyclic" drugs remained the most commonly prescribed, though the number of children receiving newer medications like Prozac and Zoloft increased dramatically in the Medicaid programs over the five years.

In the Midwestern Medicaid group, 3.2 of every 1,000 preschoolers received prescriptions for antidepressants.

Though clonidine was prescribed less frequently than stimulant drugs, the researchers said, its increased use -- was particularly notable, because there are no rigorous studies demonstrating that it is a safe or effective as a treatment for The study found that 2.3 children per 1,000 in the Midwestern Medicaid group received prescriptions for the drug in 1995, compared to 0.1 child per 1,000 in 1991.

Heart problems have been reported in children taking clonidine in combination with other drugs, including Ritalin, the researchers said.

In contrast to the increase in other drugs, the use of antipsychotic drugs for preschoolers remained constant over the five-year period at about 0.7 children per 1,000.