RISING USE OF PSYCHIATRIC DRUGS IN TODDLER CASES CALLED ALARMING

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

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

The number of children receiving prescriptions for antidepressants
doubled in the Medicaid programs. The use of clonidine, a blood
pressure drug gaining popularity as a treatment for attention
disorders, also jumped among the group of more than 200,000 children
studied.

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 under
5.

"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 1990s 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.

Previous studies have shown significant increases in the use of
stimulants and antidepressants to treat children 5 to 19. In a smaller
study of Medicaid enrollees in Michigan, done in 1998, researchers
found that of 223 children under age 4 who were identified as having
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,"
Zito said.

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 Hyman has made a priority in the institute's
funding of research.

"We clearly need clinical trials of safety and efficacy for both
pharmacological and psychosocial treatments in young children," Hyman
said.

At the same time, he added, 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 are not clear.

But experts speculated that the reasons might include the reluctance
of HMOs and subsidized medical care programs to pay for counseling or
other treatments that did not involve drugs; the pressures from
parents and schools to diagnose attention deficit hyperactivity
disorder in children; 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, 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 prescribing drugs for purposes not approved by the FDA, 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 doctor prescribes a drug off-label for a child, Zito said,
parents "should be aware that they are entering an area of
uncertainty."

The symptoms of emotional or behavioral problems displayed by children
under 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 children ages 2 and 3 looks a
lot like attention deficit hyperactivity disorder.

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 Coyle, who wrote an editorial accompanying the
report, "and we don't know what consequences are."