Use of Antipsychotics in Children Is Criticized

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_http://www.nytimes.http://wwhttp://www.nyhttp://www.nyhttp://ww_

(http://www.nytimes.com/2008/11/19/health/policy/19fda.html?_r=1)

Use of Antipsychotics in Children Is Criticized

By _GARDINER HARRIS_

(http://topics.nytimes.com/top/reference/timestopics/people/h/gardiner_harris/in\

dex.html?inline=nyt-per)

Published: November 18, 2008

WASHINGTON — 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 experts said Tuesday.

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

disorders.

But Risperdal is not approved for attention deficit problems, and its risks —

which include substantial weight gain, metabolic disorders and muscular

_tics_

(http://health.nytimes.com/health/guides/disease/transient-tic-disorder/overview\

..html?inline=nyt-classifier) 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_

(http://topics.nytimes.com/top/reference/timestopics/organizations/u/university_\

of_alabama/index.html?inline=nyt-org)

School of Medicine who was on the panel. “And we need to find a way to

accommodate this concern of ours.â€

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 & and Eli Lilly & Company. _Food and Drug

Administration_

(http://topics.nytimes.com/top/reference/timestopics/organizations/f/food_and_dr\

ug_administration/index.html?inline=nyt-org) 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 for _attention

deficit disorder_

(http://health.nytimes.com/health/guides/disease/attention-deficit-hyperactivity\

-disorder-adhd/overview.html?inline=nyt-classifier) , and I

wonder if we have given enough weight to the adverse-event profile of the

drug in light of this,†Dr. Notterman, a senior health policy analyst

at

_Princeton University_

(http://topics.nytimes.com/top/reference/timestopics/organizations/p/princeton_u\

niversity/index.html?inline=nyt-org) 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,â€

said Dr. Laughren, director of the agency’s division of _psychiatry_

(http://topics.nytimes.com/top/news/health/diseasesconditionsandhealthtopics/psy\

ch

iatry_and_psychiatrists/index.html?inline=nyt-classifier) products. “I’m

anxious to hear what more we can do in the labeling.â€

Kara , a spokeswoman for & , said, “Adverse drug

reactions associated with Risperdal use in approved indications are accurately

reflected in the label.â€

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 effects.

A consortium of state _Medicaid_

(http://topics.nytimes.com/top/news/health/diseasesconditionsandhealthtopics/med\

icaid/index.html?inline=nyt-classifier)

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 disorder_

(http://health.nytimes.com/health/guides/disease/bipolar-disorder/overview.html?\

inline=nyt-classifier)

.

The leading advocate for the bipolar diagnosis is Dr. ph Biederman, a

child psychiatrist at _Harvard University_

(http://topics.nytimes.com/top/reference/timestopics/organizations/h/harvard_uni\

versity/index.html?inline=nyt-org)

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_

(http://health.nytimes.com/health/guides/specialtopic/getting-a-prescription-fil\

led/overview.html?inline=nyt-cl

assifier) to patients 17 and younger increased 10 percent, while

prescriptions among adults declined 5 percent. Most of the pediatric

prescriptions were

written by _psychiatrists_

(http://topics.nytimes.com/top/news/health/diseasesconditionsandhealthtopics/psy\

chiatry_and_psychiatrists/index.html?inline=nyt-c

lassifier) .

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 safety.

Dr. Dure said he was concerned that doctors often failed to recognize the

movement disorders, including _tardive dyskinesia_

(http://health.nytimes.com/health/guides/disease/tardive-dyskinesia/overview.htm\

l?inline=nyt-classifier)

and _dystonia_

(http://health.nytimes.com/health/guides/symptoms/movement-uncontrolled-or-slow/\

overview.html?inline=nyt-classifier) , 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’ side effects.

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