Kids Using More Psych Drugs
By Shawna Vogel, ABCNEWS.com
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."