Powerful Antipsychotic Medicines Are Being
Prescribed Far Too Often To Children
Powerful antipsychotic medicines are being used far too cavalierly
in children, and federal drug regulators must do more to warn
doctors of their substantial risks, a panel of federal drug
More than 389,000 children and teenagers were treated last
year with Risperdal, one of five popular medicines known as
atypical antipsychotics. Of those patients, 240,000 were 12
or younger, according to data presented to the committee. In
many cases, the drug was prescribed to treat attention deficit
But Risperdal is not approved for attention deficit problems,
and its risks which include substantial weight gain,
metabolic disorders and muscular tics that can be permanent
are too profound to justify its use in treating such
disorders, panel members said.
“This committee is frustrated,” said Dr. Leon Dure,
a pediatric neurologist from the University of Alabama School
of Medicine who was on the panel. “And we need to find
a way to accommodate this concern of ours.”
The meeting on Tuesday was scheduled to be a routine review
of the pediatric safety of Risperdal and Zyprexa, popular antipsychotic
medicines made, respectively, by Johnson & Johnson and Eli
Lilly & Company. Food
and Drug Administration officials proposed that the committee
endorse the agency’s routine monitoring of the safety
of the medicines in children and support its previous efforts
to highlight the drugs’ risks.
But committee members unanimously rejected the agency’s
proposals, saying that far more needed to be done to discourage
the medicines’ growing use in children, particularly to
treat conditions for which the medicines have not been approved.
“The data show there is a substantial amount of prescribing
deficit disorder, and I wonder if we have given enough weight
to the adverse-event profile of the drug in light of this,”
Dr. Daniel Notterman, a senior health policy analyst at Princeton
University and a panel member, said when speaking about Risperdal.
Drug agency officials responded that they had already placed
strongly worded warnings on the drugs’ labels.
“I’m a little puzzled about the statement that
the label is inadequate,” said Dr. Thomas Laughren, director
of the agency’s division of psychiatry products. “I’m
anxious to hear what more we can do in the labeling.”
Kara Russell, a spokeswoman for Johnson & Johnson, said,
“Adverse drug reactions associated with Risperdal use
in approved indications are accurately reflected in the label.”
But panelists said the current warnings were not enough.
While panel members spoke at length about Risperdal, they said
their concerns applied to the other medicines in its class,
including Zyprexa, Seroquel, Abilify and Geodon.
The committee’s concerns are part of a growing chorus
of complaints about the increasing use of antipsychotic medicines
in children and teenagers. Prescription rates for the drugs
have increased more than fivefold for children in the past decade
and a half, and doctors now use the drugs to settle outbursts
and aggression in children with a wide variety of diagnoses,
even though children are especially susceptible to their side
A consortium of state Medicaid directors is evaluating the
use of the drugs in children on state Medicaid rolls to ensure
that they are being properly prescribed.
The growing use of the medicines has been driven partly by
the sudden popularity of the diagnosis of pediatric bipolar
The leading advocate for the bipolar diagnosis is Dr. Joseph
Biederman, a child psychiatrist at Harvard University whose
work is under a cloud after a Congressional investigation revealed
that he had failed to report to his university at least $1.4
million in outside income from the makers of antipsychotic medicines.
In the past year, Risperdal prescriptions
to patients 17 and younger increased 10 percent, while prescriptions
among adults declined 5 percent. Most of the pediatric prescriptions
were written by psychiatrists.
From 1993 through the first three months of 2008, 1,207 children
given Risperdal suffered serious problems, including 31 who
died. Among the deaths was a 9-year-old with attention deficit
problems who suffered a fatal stroke 12 days after starting
therapy with Risperdal.
At least 11 of the deaths were children whose treatment with
Risperdal was unapproved by the F.D.A. Once the agency approves
a medicine for a particular condition, doctors are free to prescribe
it for other problems.
Panel members said they had for years been concerned about
the effects of Risperdal and similar medicines, but F.D.A. officials
said no studies had been done to test the drugs’ long-term
Dr. Dure said he was concerned that doctors often failed to
recognize the movement disorders, including tardive dyskinesia
and dystonia, that can result from using these medicines.
“I have a bias that extra-pyramidal side effects are
being under-recognized with these agents,” Dr. Dure said.
Dr. Laughren of the F.D.A. said the agency could do little
to fix the problem. Instead, he said, medical specialty societies
must do a better job educating doctors about the drugs’