For those using Risperdal....

[Guest guest]

For those of you with questions about Risperdal, I got this off of

another group. Also, wish us luck...we leave today for Disney World

with Mason!!!!!

Use of Antipsychotics in Children Is Criticized

By GARDINER HARRIS

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 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 & 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 for

attention deficit disorder, 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 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. Laughren, director of the agency's

division of psychiatry products. " I'm anxious to hear what more we

can do in the labeling. "

Kara , a spokeswoman for & , 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 effects.

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 disorder.

The leading advocate for the bipolar diagnosis is Dr. ph

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 safety.

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' side effects.