Antipsychotics Killed at least 45 Children_FDA Not Concerned

May 3, 2006

--USA Today

Wednesday, 03 May 2006

" I trusted the doctors, I trusted the FDA ... and I feel betrayed

by both, " says , the mother of Rex who was prescribed

the 'atypical' antipsychotic, Risperdal (risperidone) at age 8.

The drug damaged his brain--he now has to live with tardive

dyskinesia (TD), an irreversible, severely disfiguring, neurological

condition which is a risk linked to ALL antipsychotics. The

manufacturer, Janssen, says, " Nobody knows how many children on

atypicals get TD, but it's rare in adults. "

An investigative report in USA Today (below) documents the awful

truth about antipsychotic drug-induced harm being perpetrated on

America's children--while FDA officials pretend nothing out of the

ordinary is happening.

Marilyn Elis of USA TODAY reviewed FDA's Medwatch adverse event

report database (from 2000 to 2004) and found " at least 45 deaths of

children in which an atypical anti-psychotic was listed as

the " primary suspect. " One-fourth of the cases in the database did

not list the patient's age. In addition, there were 1,328 reports

of bad side effects, some of them life-threatening.

The Medwatch database represents only 1% to 10% of drug-induced side

effects and deaths. Expert clinical pharmacologist Alastair J.J.

Wood (Vandebilt University) suggests it represents, " maybe even less

than 1%. "

When confronted with children's death toll, Laughren,

director of FDA's division of psychiatry products, is quoted

stating: " we haven't been alerted to any particular or unusual

concern. The effects (in kids) are similar to what we're seeing in

adults. We have not systematically looked at the data for children "

because the drugs aren't approved for them. "

Among the life-threatening adverse events reported to Medwatch: 41

children nearly died of a drug-induced toxic reaction--neuroleptic

malignant syndrome NMS). Child psychiatrist ph Penn of Bradley

Hospital and Brown University School of Medicine, said NMS was the

most troubling effect listed. " It is life-threatening and can kill

within 24 hours of diagnosis. It's been linked to drugs that act on

the brain's dopamine receptors, which would include the atypicals. "

Antipsychotic drugs are the most toxic of all psychotropic drugs--

they are approved for adults disabled by schizophrenia and for short-

term use in patients with manic-depression (bipolar). Yet, a

Vanderbilt study found that more than 2.5 million children--some as

young as 18 months--are being prescribed these toxic drugs without

parents ever being told about the harm these drugs might cause--

Dr. Findling, a child psychiatrist at University Hospitals of

Cleveland, states: " These anti-psychotics are the most widely used

class of drugs to treat disruptive kids who attack others and defy

adults. Again, there's a paucity of proof that the drugs help. "

Whereas other studies of psychotropic drug prescribing for children

reviewed Medicaid records, USA TODAY contracted Medco to do an

analysis of outpatient prescriptions for children who are privately

insured. In a sampling of about 2.5 million of Medco's 55 million

members, they found the rate of children 19 and under with at least

one atypical prescription jumped 80% from 2001 to 2005 — from 3.6

per 1,000 to 6.5 per 1,000.

USA Today investigated the dark side of current practice by mental

health professionals--some call it criminal malpractice and child

abuse. They bring to public attention how children are being

victimized by irresponsible doctors whose aggressive prescribing of

antipsychotic drugs for children has run amok—the consequences are

borne by children, some of who are brain damaged, disabled, or dead.

This is the story The New York Times wouldn't touch!

More than half of the kids who died were on at least one other

psychiatric drug besides the atypical anti-psychotic, and many were

taking drugs for other ailments. The youngest, a 4-year-old boy

whose symptoms suggested diabetes complications, was taking 10 other

drugs. "

" Some parents tell stories of serious effects that linger long after

their kids stop taking the drugs. Rex ' parents are bitter

about what happened to their son. They believe the 13-year-old

Colorado Springs boy was harmed permanently by an atypical anti-

psychotic he took several years ago. Rex now has a serious case of

tardive dyskinesia (TD), suffering daily episodes of involuntary

jerking movements and facial grimacing, says , his

mother. " " An 8-year-old boy had cardiac arrest. A 15-year-old boy

died of an overdose. A 13-year-old girl experienced diabetic

ketoacidosis, a deficiency of insulin.

The story of Evan Kitchens who had problems from birth, having

suffered from lack of oxygen during a difficult delivery, is an

indictment of psychiatry and its obsession with drugs. Beginning at

18 months, Evan was prescribed one after another psychotropic drug

which exacerbated whatever troubling behavior he exhibited--

his " diagnoses " shifting with the drugs and drug cocktails. The

child was prescribed his first of several antipsychotic drugs at age

3 1/2. Until he was finally taken off drugs he says he was in a fog.

His mother wishes she had gone the non-drug route earlier. " I didn't

even know what was available ... I totally relied on the doctors. "

is one parent who wishes she had never heard of anti-

psychotics. Her son, Rex, was prescribed Risperdal at age 8: " After

one month on Risperdal, Rex started having tremors; within a few

months, his hands shook so severely that he could barely write at

school, " and I'd have to guide the cup of milk to his mouth in the

morning, " says. But the psychiatrist said the tremors weren't

so bad, says, and urged the family to continue the drug. The

psychiatrist didn't pressure them, she says, " but I'm from the

generation where, when a doctor says something, you believe it. "

" The parents started to learn more about Risperdal and, for the

first time, they realized that Rex's symptoms could be side effects,

so they started to wean him off the drug. In a few weeks they

noticed his jaw was scrunching up and his facial expressions were

becoming distorted. By then, says, she had read up on tardive

dyskinesia (TD), a neurological disorder that can be caused by anti-

psychotics. Rex became less anxious, but the TD worsened. " He had a

horrible, ugly look on his face all the time, " says. Friends

no longer came to play. Rex went from winning an award for best

reader in the third grade to claiming he couldn't remember how to

spell his own name in fourth grade. "

When confronted with the evidence, some of psychiatry's leading

child psychiatrists, for the first time, disavowed current

prescribing practices, including the loose labeling of children

as " bipolar: "

Dr. March (Duke University) acknowledges, " We have no evidence

about the safety of these agents or their effectiveness in

controlling aggression, " he says. " Why are we doing this? "

Kuhn, a Duke University pharmacologist is aghast as

well: " The brain system that the drugs work on develops through

childhood and adolescence. We really don't know the impact of

chronically perturbing that system in childhood. "

Dr. Jensen, head of Columbia University's center for advancing

childrent's mental health, expressed concern about over-diagnosis

and " jumping to this (bipolar) label too quickly. "

Dr. Barbara Geller, one of the major proponents of diagnosing

children as bipolar, who served on the influential psychotropic drug

prescribing guideline pane that helped encourage the prescribing of

antipsychotics for children (TMAP), made an astounding statement,

acknowledging the absence of science in psychiatry: " The science is

nowhere near where it is in other branches of medicine. "

Yet, (as is documented in today's companion Infomail) academic

psychiatrists whose financial ties to drug manufacturers has been

the subject of criticism on both sides of the Atlantic, are

conducting experiments whose risk/ benefit ratio for the child

subjects is disadvantageous. The only plausible purpose for

conducting such experiments is commercial: to legitimize

illegitimate, off-label prescribing of toxic drugs for children—as

described in the USA Today report. These commercially driven

experiments are designed to demonstrate short-term efficacy which

would justify wide prescribing.

The evidence presented in this series is an indictment of current

prescribing practice which is rooted in: the absence of science, the

absence of reliable diagnostic tools, often resulting in

misdiagnosis, parents' ignorance and doctors denial / concealment

of these drugs' harmful effects—both short-term and irreversible.

Finally, the unprecedented prescribing of such toxic drugs mostly to

control behavior, not illness.

However, USA Today's choice of organizations to which families

seeking information are sent, undermines the message. Readers are

referred to websites of organizations that are the very promoters of

psychotropic drug treatment and the pathologizing of children. They

promoted psychotropic drugs claiming they were " safe and effective " –

even as black box warnings were added to the labels. These

organizations have financial a stake in the psychotropic drug

industry which supports them. Either the editor didn't understand

the reason children are suffering and dying from drugs they should

not be exposed to, or he is sabotaging this powerful investigative

news report.

These are the very groups that have contributed to the problems

described in the series.

The Academy of Child and Adolescent Psychiatry, Child & Adolescent

Bipolar Foundation (bpkids), the NIMH, First Signs…

See list of Pharma supporters: http://www.bpkids.org/site/PageServer?

pagename=ppl_organizational_donors

For credible information about the drugs, the science, the

profitability of these drugs—and for other credible sources of

information, visit the AHRP website.

Contact: Vera Hassner Sharav

veracare@...

http://www.usatoday.com/news/health/2006-05-01-atypical-drugs_x.htm

USA TODAY

New anti-psychotic drugs carry risks for children

By Marilyn Elias,

5/2/2006 1:20 AM ET

remembers the bad old days when she had to wear long-

sleeve clothes to church to cover bite marks all over her arms from

her daughter a's rages.

At age 8, a was diagnosed with bipolar disorder. She was a

violent child with sharp mood swings and meltdowns that drove her to

tear up the house. Antidepressants and drugs for attention-deficit

disorder had only made a more aggressive, says.

A mix of medicines including so-called atypical anti-psychotics —

drugs approved only for adults — finally stabilized a's moods.

Now at 15, she is able to live a more normal life — as long as she

takes the medication.

Even so, the ville, Mo., teen is paying a price: On one of

the atypical anti-psychotics, a gained about 100 pounds in a

year, putting her at risk for a host of health problems, including

diabetes. It has taken her three years to lose a third of that extra

weight; she is still struggling with the rest.

Atypicals are a new generation of anti-psychotic drugs approved by

the Food and Drug Administration for adult schizophrenia and bipolar

disorder (manic depression). None of the six drugs — Clozaril,

Risperdal, Zyprexa, Seroquel, Abilify and Geodon — is approved for

kids, but doctors can prescribe them as " off-label " medications.

Psychiatrists say the drugs can be helpful for children with serious

mental illnesses and have been known to save young lives. But

diagnosis often is difficult, making appropriate prescribing tricky.

And many experts, including behavioral pediatrician Lawrence Diller,

author of Should I Medicate My Child?, say there is growing overuse

of these powerful anti-psychotics.

Schizophrenia is rare in children under 18: It strikes about 1 in

40,000, as opposed to 1 in 100 adults, according to the National

Institute of Mental Health. Nobody knows exactly how many kids have

bipolar disorder; psychiatrists don't even agree on criteria to

diagnose the disease in childhood.

Research on how the drugs affect children is sparse, and experts

increasingly are concerned that the drugs are being prescribed too

often for children with behavior problems, such as attention-deficit

disorder and aggression.

March, chief of child and adolescent psychiatry at Duke

University School of Medicine, prescribes the drugs to kids in some

cases of serious illness when he thinks the benefits outweigh the

risks. But he says prescribing them for behavior problems alone may

be a mistake. " We have no evidence about the safety of these agents

or their effectiveness in controlling aggression, " he says. " Why are

we doing this? "

At the same time, reports of deaths and dangerous side effects

linked to the drugs are mounting. A USA TODAY study of FDA data

collected from 2000 to 2004 shows at least 45 deaths of children in

which an atypical anti-psychotic was listed in the FDA database as

the " primary suspect. " There also were 1,328 reports of bad side

effects, some of them life-threatening.

Drug companies are required to file any reports they have to the

FDA, but consumers and doctors report such events on a voluntary

basis. Studies suggest the FDA's Adverse Events Reporting System

database captures only 1% to 10% of drug-induced side effects and

deaths, " maybe even less than 1%, " says clinical pharmacologist

Alastair J.J. Wood, an associate dean at Vanderbilt Medical School

in Nashville. So the real number of cases is almost certainly much

higher.

" We're conducting a very large experiment on our children, " March

says.

Side effects that linger

Some parents tell stories of serious effects that linger long after

their kids stop taking the drugs. Rex ' parents are bitter

about what happened to their son. They believe the 13-year-old

Colorado Springs boy was harmed permanently by an atypical anti-

psychotic he took several years ago. Rex now has a serious case of

tardive dyskinesia (TD), suffering daily episodes of involuntary

jerking movements and facial grimacing, says , his mother.

Anti-psychotics are known to cause TD, but it's thought to be a rare

effect for the newer atypicals. Despite such reports, outpatient

prescriptions for kids ages 2 to 18 leaped fivefold — from just

under half a million to about 2.5 million — from 1995 to 2002,

according to a new analysis of a federal survey by Vanderbilt

Medical School researchers. This doesn't include prescriptions at

psychiatric hospitals or residential treatment centers.

And even though the drugs are approved only for adults, the rate of

children treated with atypicals " is growing dramatically faster than

the rate for adults, " says Epstein, chief medical officer for

Medco Health Solutions, pharmacy benefit managers.

Medco did an analysis of outpatient prescriptions for USA TODAY and

found that, in a sampling of about 2.5 million of Medco's 55 million

members, the rate of children 19 and under with at least one

atypical prescription jumped 80% from 2001 to 2005 — from 3.6 per

1,000 to 6.5 per 1,000. And that only represents kids who are

privately insured, not those in foster care or others on Medicaid.

" We know these are very strong medicines, " Epstein says. " You'd want

to be absolutely sure the child needs it. "

The more serious risks

Because of the nature of the FDA data, they don't prove that these

drugs caused the deaths or the side effects. Many side effects for

which an atypical is listed as the " primary suspect " occurred in the

normal course of using the drug, but the database also includes

cases involving drug abuse, overdoses, suicides and homicides.

Entries are sometimes cryptic, and the FDA enters verbatim —

misspellings and all — what's reported on the form.

Still, the data " can be a useful signaling device " suggesting

problems with a drug that warrant conclusive studies, says Jerome

Avorn, a pharmacology specialist at Harvard Medical School and

author of the book Powerful Medicines.

One-fourth of the cases in the database studied by USA TODAY did not

list the patient's age. But in cases that listed an age under 18:

•A condition called dystonia was most often cited as an " adverse

event " suffered by someone taking one of the drugs, with 103

reports. Dystonia produces involuntary, often painful muscle

contractions.

•Tremors, weight gain and sedation often were cited, along with

neurological effects such as TD. Symptoms of TD can vary from slight

twitching to full-blown jerking of the body.

•A condition called neuroleptic malignant syndrome, with 41

pediatric cases over the five years, was the most troubling effect

listed, says child psychiatrist ph Penn of Bradley Hospital and

Brown University School of Medicine. It is life-threatening and can

kill within 24 hours of diagnosis. It's been linked to drugs that

act on the brain's dopamine receptors, which would include the

atypicals, Penn says.

The FDA office of drug safety checks the database, " and we haven't

been alerted to any particular or unusual concern, " says

Laughren, director of the agency's division of psychiatry

products. " The effects (in kids) are similar to what we're seeing in

adults. We have not systematically looked at the data for children "

because the drugs aren't approved for them, he says.

The 45 deaths

Among the 45 pediatric deaths in which atypicals were the primary

suspect, at least six were related to diabetes — atypicals carry

warnings that the drugs may increase the risk of high blood sugar

and diabetes. Other causes of death ranged from heart and pulmonary

problems to suicide, choking and liver failure.

An 8-year-old boy had cardiac arrest. A 15-year-old boy died of an

overdose. A 13-year-old girl experienced diabetic ketoacidosis, a

deficiency of insulin.More than half of the kids who died were on at

least one other psychiatric drug besides the atypical anti-

psychotic, and many were taking drugs for other ailments.

The youngest, a 4-year-old boy whose symptoms suggested diabetes

complications, was taking 10 other drugs. The reports don't tell the

child's general state of health or other factors that could

predispose him to trouble. Also, neither Clozaril, which is rarely

used, nor Abilify, the newest atypical, was listed as a primary

suspect in any deaths.

All the drugmakers emphasize that their products are not approved

for children, and they say the drugs are safe and effective for

adults with schizophrenia or bipolar disorder who are monitored for

side effects. Still, " there are worrisome questions here, " says

Avorn. Large, longer-term database studies could provide answers, he

says.

There's some evidence that the drugs can help young schizophrenics

and may be helpful in treating bipolar disorder in children, says

Findling, a child psychiatrist at University Hospitals of

Cleveland. But the data from controlled studies " are too few to

guide treatment decisions " on bipolar disorder, concluded Findling's

research team in a summary of pediatric studies published in the

Journal of Clinical Psychiatry.

These anti-psychotics are the most widely used class of drugs to

treat disruptive kids who attack others and defy adults, Findling

says. Again, there's a paucity of proof that the drugs help. There

are only a handful of carefully controlled, sizable studies testing

the drugs for any pediatric disorder, and they're mostly short-term,

says Benedetto Vitiello, chief of child and adolescent psychiatry at

the national mental health institute. The most serious, widespread

problem found to be caused by the medicines is weight gain, he says.

The effect varies by drug, but kids typically put on twice the

pounds they should in their first six months on atypicals.

In the first three months on the drugs, children add about 2 to 3

inches to their waistlines, says research psychiatrist Christoph

Correll of Zucker Hillside Hospital in Glen Oaks, N.Y. A lot of this

is abdominal fat, which increases the risk of diabetes and heart

disease. Obese children are twice as likely as normal-weight

children to have diabetes, according to a new University of Michigan

study.

" Some patients gain weight on Zyprexa and others do not, " says

Calvin Sumner, a medical adviser to Eli Lilly Research Laboratories.

Lilly makes the drug, which has been associated with weight gains in

adult studies. Sumner stresses that Zyprexa isn't approved for kids.

There's no proof atypicals cause diabetes, says Ramy Mahmoud of

Janssen LP, maker of Risperdal. He says the FDA added a label

warning of increased diabetes risk " to make people aware of the

possibility. "

One key question about atypicals is whether they will have long-

term, unknown effects on the brains of children. The brain system

that the drugs work on develops through childhood and adolescence,

says Kuhn, a Duke University pharmacologist. " We really

don't know the impact of chronically perturbing that system in

childhood. "

Why atypicals get prescribed

Given all the potential problems, why would doctors prescribe these

drugs to children to begin with? Nobody disputes that the lives of

schizophrenic or severely manic children may be saved by anti-

psychotics. " I use them myself for patients, " says March, the Duke

psychiatrist. " I have a 9-year-old who threatened to jump out of a

second-story window if her mom didn't give her the car keys to drive

down to the 7-Eleven to get a Coke. If I took her off anti-

psychotics, she'd disintegrate. "

But several factors can lead to misprescribing of anti-psychotics.

It can be difficult to tell one behavioral disorder or illness from

another in kids. For example, the aggression and irritability of

bipolar disorder can mimic attention-deficit hyperactivity disorder

or depression, the mental health institute says. Also, the

environment can be a key cause of symptoms that may be mistakenly

diagnosed as mental disorders, says Diller, the behavioral

pediatrician.

Some events in a child's life can trigger acting-out or other

symptoms. Adults can explain what happened to them; children,

especially the youngest, may be more reticent.

Doctors often face time pressures that prevent them from finding out

what's going on in kids' lives, knowledge that might suggest

alternative treatments, Penn says. For example, abuse of drugs such

as methamphetamine, OxyContin and cocaine is fairly common among

teens, he says. Kids begin acting strangely, hearing voices,

becoming paranoid. The symptoms can mimic psychosis or behavioral

disorders, and doctors can end up giving these children unneeded

anti-psychotic drugs, he says.

Insurance coverage rules may encourage the soaring use of anti-

psychotics for children, as well. " With some companies, the only

thing they reimburse for is prescribing. There's little or no

therapy, " says Brown, editor of the Journal of Pediatric

Psychology and a dean at Temple University.

Also, kids with serious mental health problems often have at least

one hospitalization, but policies cover only a week or two. It can

take a couple of weeks just to get medical records and family

histories, Penn says, but insurers often extend time if there's a

new medicine started, which encourages drug dabbling for children

who are not ready to go home. In the end, some parents say their

children have such severe behavior disorders or mental illness that

the benefits outweigh risks.

Parents of children such as a , who have bipolar disorder,

say the atypicals often help. " We were very fortunate, " says a's

mother, special-education director for the ville, Mo., school

district. " The medication worked for my daughter. It doesn't work

for everybody. "

Misdiagnosis common

The Vanderbilt study of anti-psychotic prescribing finds at least

13% of pediatric prescriptions are for bipolar disorder. But there

is some concern about over-diagnosis and " jumping to this (bipolar)

label too quickly, " says psychiatrist Jensen, head of the

Center for the Advancement of Children's Mental Health at Columbia

University.

Spencer's son, , was diagnosed as bipolar at age 6 and

put on atypicals. He developed liver abnormalities and obesity, his

mother says. " He's been on a smorgasbord of meds, " she says. None

worked well for very long. By the time he was in sixth grade,

doctors said they weren't sure was bipolar after all. Now

15, he is on low doses of an antidepressant and mood stabilizer.

He's being weaned off both, says Spencer, executive director of the

Federation of Families for Children's Mental Health, a support group.

She worries about how the drugs have affected , who is black:

As little psychiatric drug research as there is on children, there's

least of all on minority kids. Some drugs are known to affect black

adults differently from whites. " He probably had ADHD all along, "

Spencer says. " Psychiatry is so not an exact science. "

Child psychiatrist Barbara Geller, a bipolar expert at Washington

University in St. Louis, agrees: " The science is nowhere near where

it is in other branches of medicine. "

So parents struggle to make the right decisions for very troubled

kids. " There's a lot of fear among parents, " Spencer says. " You

don't know what the effects of these drugs are going to be. You're

at the mercy of your doctor. " I have had to make a lot of

decisions, and they were fear-driven. You don't have enough

information to make an intelligent decision. "

<http://news./s/usatoday/20060502/ts_usatoday/$arg%

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http://www.usatoday.com/news/health/2006-05-01-kids-

overprescribe_x.htm?POE=click-refer

A rush to overprescribe?

5/2/2006 12:19

Rising numbers of U.S. children are taking a new generation of anti-

psychotic drugs called atypicals. Although the six drugs — Clozaril,

Risperdal, Zyprexa, Seroquel, Abilify and Geodon — can be helpful in

treating children with mental illness, critics say that the drugs

are overprescribed and that many kids suffer serious side effects

from drugs they never needed.

Evan Kitchens had problems from birth. He suffered from lack of

oxygen during a difficult delivery. As a baby, he wouldn't nurse

properly, didn't want to be held and screamed for hours. " He hardly

slept at all, " says his mother, Kitchens, a florist in Bandera,

Texas.

At 18 months old, Evan was diagnosed with an autism spectrum

disorder and prescribed Adderall, a drug to treat attention-deficit

hyperactivity disorder. But Evan just got more aggressive and

hyperactive. When he was 2, he knocked out the front teeth of his

younger brother with a flashlight. The family began a constant round

of appointments with child psychiatrists and other doctors.

At 2½, Evan was diagnosed with obsessive-compulsive disorder. When

he was 3, doctors put him on Risperdal, his first anti-psychotic.

But in a " special needs " preschool, his aggressive behavior

continued. He was out of control, racing out of the classroom,

hitting other kids.

At 5 Evan was hospitalized for the first time. He was still on

Risperdal and two other drugs, supposedly to stabilize his moods and

curb hyperactivity. But nothing had worked well for long. Kitchens

says she tried doctor after doctor. She had insurance only on and

off; her husband disappeared when twins were born 16 months after

Evan, she says, so she became the family's sole support.

" Every drug created new symptoms, and then you had to treat those

symptoms, " she says. " We were constantly changing meds. I see now

what we were really managing was symptoms of the drugs, not his

underlying problem. "

In April 2004, at age 8, Evan set fire to the bedroom carpet with a

candle. Fortunately, 14-year-old Ethan, Evan's older brother, saw

the fire before anyone was hurt.

Evan was hospitalized in San . The family drove three hours

every day, Kitchens says, to bring Evan dinner and spend time with

him. Now doctors said he might have bipolar disorder.

Evan had been on Risperdal and the mood stabilizer Lithium. Doctors

added Seroquel to the mix. Within a month, he showed tremors,

Kitchens says. " They got so bad, he was shaking all the time. "

Evan's eyes started to cross. Still, doctors thought it was

important to keep him on the drugs. They added two more mood

stabilizers. Soon Evan had a thyroid disorder and an abnormally low

white blood cell count, Kitchens says.

In August, Evan was transferred to another center and weaned off

everything but Seroquel and a drug for attention-deficit disorder.

His alertness returned, but other symptoms lingered for months.

In January 2005, Evan came home. Kitchens gradually took him off

Seroquel and says he's doing better than ever just taking medicine

for ADD. He has had intensive behavior-management therapy; so has

the whole family. His alarming symptoms are gone, but his eyes still

cross occasionally if he's tired.

Many child psychiatrists are frustrated by the lack of drugs to

treat kids with mental disorders, says Wayne Macfadden, U.S. medical

director for Seroquel, which is made by AstraZeneca. But Seroquel

isn't approved for children, he says. " Obviously, prescribers have

to weigh the risks and benefits. "

Evan made the honor roll in regular school his first semester home,

Kitchens says. He sang in the school's Christmas choir, played

basketball and is making friends. His mother wishes she had gone

the non-drug route earlier. " I didn't even know what was

available ... I totally relied on the doctors. "

Evan says his time of live-in care " is like a blur. I remember my

stomach would hurt, and my head would hurt. I slept a whole lot. And

then I started to see two of things. I was very scared. " He says

he's happy to be home: " Nothing hurts anymore. "

If doctors recommend the drugs he took for other kids, Evan has some

advice for their parents: " Sometimes it's good for them, sometimes

it's bad for them. I would warn them about the bad things that can

happen. "

~~~~~~~~~~~~~~~

http://www.usatoday.com/news/health/2006-05-02-antipsychotic-side-

effects_x.htm?POE=click-refer

Drug therapy caused some scary side effects

Updated 5/2/2006 8:49 AM ET

By Marilyn Elias, USA TODAY

is one parent who wishes she had never heard of anti-

psychotics.

As a military couple, she and her husband, Joe, moved around

frequently. Their son, Rex, 13, was babied a lot. His mother now

feels that he was not ready for school when he reached kindergarten

age. He had trouble focusing in the classroom and was diagnosed

with attention-deficit disorder at age 6. He started on an ADHD

medicine and began hallucinating about worms and bugs in his food.

Soon he was also on Prozac for anxiety, but the nervousness and

paranoia persisted.

At age 8, Rex was given Risperdal by a Tennessee child psychiatrist

in private practice who consulted for the military. He said the boy

probably had obsessive-compulsive disorder, too, says. " (He)

didn't tell us it had never been approved for children or warn us

about any side effects, " she says. For the first few weeks,

Risperdal helped a little; Rex became less anxious and hyper. " But

then it wore right off, so the doctor kept increasing the dose, " she

says.

After one month on Risperdal, Rex started having tremors; within a

few months, his hands shook so severely that he could barely write

at school, " and I'd have to guide the cup of milk to his mouth in

the morning, " says. But the psychiatrist said the tremors

weren't so bad, says, and urged the family to continue the

drug. The psychiatrist didn't pressure them, she says, " but I'm

from the generation where, when a doctor says something, you believe

it. "

Then, about a year after Rex started Risperdal, the es found

out that he might have schizoaffective disorder, a psychotic illness

that children rarely get. A doctor's report said Rex probably would

need to be institutionalized. That year, when Rex was 9, the family

moved to Colorado Springs. The parents started to learn more about

Risperdal and, for the first time, they realized that Rex's symptoms

could be side effects, so they started to wean him off the drug. In

a few weeks they noticed his jaw was scrunching up and his facial

expressions were becoming distorted. By then, says, she had

read up on tardive dyskinesia (TD), a neurological disorder that can

be caused by anti-psychotics.

Rex became less anxious, but the TD worsened. " He had a horrible,

ugly look on his face all the time, " says. Friends no longer

came to play. Rex went from winning an award for best reader in the

third grade to claiming he couldn't remember how to spell his own

name in fourth grade. Then in fifth grade, Rex slowly began to

improve. A medical exam showed spasms in his thorax, perhaps linked

to the upper body spasms, restricting the flow of oxygen to his

brain.

He began oxygen therapy, and he quickly became more responsive to

others and did better at school, says. He also had behavioral

therapies. At the end of elementary school, Rex had episodes only a

few times a week. But junior high has brought more stress and

bullying, and the episodes have become more frequent. " His movement-

disorder specialist said he expected Rex to have this for the rest

of his life, " says.

Now she is bitter. " I trusted the doctors, I trusted the FDA ... and

I feel betrayed by both, " she says.

The Food and Drug Administration " does not regulate the practice of

medicine, " says Laughren, head of the division of psychiatry

products. He adds that he's concerned about the use of such drugs in

kids without systematic safety data.

Nobody knows how many children on atypicals get TD, says Ramy

Mahmoud of Janssen LP, maker of Risperdal, but it's rare in

adults. " Our drug isn't indicated for children, " he says. " It's a

strong drug. It has risks and benefits. Doctors and patients

together have to weigh the benefits, at the start and on a

continuing basis, along with the harm and suffering. "

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May 3, 2006