Antipsychotics Killed at least 45 Children_FDA Not Concerned –USA Today

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, Thomas 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 Joseph 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. Robert 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 Evans’ 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 Erin Evans, 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.”

Erin Evans 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,” Evans says.  But the psychiatrist said the tremors weren’t so bad, Evans 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, Evans 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,” Evans 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. John 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?”

Cynthia 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. Peter 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@ahrp.org

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

Nancy Thomas 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 Alexa’s rages.
At age 8, Alexa 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 Alexa more aggressive, Thomas says.

A mix of medicines including so-called atypical anti-psychotics — drugs approved only for adults — finally stabilized Alexa’s moods. Now at 15, she is able to live a more normal life — as long as she takes the medication.

Even so, the Russellville, Mo., teen is paying a price: On one of the atypical anti-psychotics, Alexa 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.

John 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 Evans’ 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 Erin Evans, 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 Robert 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 Joseph 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 Thomas 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 Robert 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 Cynthia 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 Ronald 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 Alexa Thomas, who have bipolar disorder, say the atypicals often help. “We were very fortunate,” says Alexa’s mother, special-education director for the Russellville, 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 Peter Jensen, head of the Center for the Advancement of Children’s Mental Health at Columbia University.

Sandra Spencer’s son, Stephen, 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 Stephen 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 Stephen, 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.”
Contributing: Susan O’Brian  Copyright © 2006 USA TODAY

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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, Mary 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 Antonio. 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

Erin Evans 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, Evans 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,” Evans says.  But the psychiatrist said the tremors weren’t so bad, Evans 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 Evanses 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, Evans 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,” Evans 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, Evans 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,” Evans 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 Thomas 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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