USA Today: New antipsychotic drugs carry risks for children

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-----Original Message-----From: AutismRecoveryNetwork [mailto:AutismRecoveryNetwork ]On Behalf Of Sandy MavrickSent: Saturday, May 06, 2006 5:55 PMTo: AutismRecoveryNetwork Subject: [AutismRecoveryNetwork] FW: USA Today: New antipsychotic drugs carry risks for children

>New antipsychotic drugs carry risks for children><http://www.usatoday.com/news/health/2006-05-01-atypical-drugs_x.htm> By Eileen Blass, USA TODAY>> Rex , left, a student at Junior High in Colorado>Springs, suffers from involuntary jerking, which his parents believe>was caused by atypical anti-psychotic drugs.>> DO DRUGS HELP OR HARM?>> New antipsychotic drugs carry risks for children><http://www.usatoday.com/news/health/2006-05-01-atypical-drugs_x.htm>>> *Perspectives:* One family's success story><http://www.usatoday.com/news/health/2006-05-02-antipsychotic-success_x.htm>>| Mom feels betrayed by doctors, FDA><http://www.usatoday.com/news/health/2006-05-02-antipsychotic-side-effects_x.htm>>> Adult antipsychotics can worsen troubles><http://www.usatoday.com/news/health/2006-05-01-adult-antipsychotics-kids_x.htm>>> For foster kids, oversight of prescriptions is scarce><http://www.usatoday.com/news/health/2006-05-01-antipsychotics-foster-kids_x.htm>>> A rush to overprescribe?><http://www.usatoday.com/news/health/2006-05-01-kids-overprescribe_x.htm>>> *Opinion:* An outraged journalist and father discovers the mental>health system is in 'shambles'><http://www.usatoday.com/news/opinion/editorials/2006-05-01-mental-illness_x.htm>>> Enlarge> Eileen Blass, USA TODAY>> Rex and his mother, Kricket , at the dinner table at home. Rex>has a movement disorder called tardive dyskinesia which causes him to>grimace and make involuntary movements.>> ABOUT THIS REPORT>> To study the growing use of atypical anti-psychotic medications>among children, as well as the symptoms associated with their use,>USA TODAY analyzed data from several public and private sources.>> For information on illnesses and deaths potentially related to>atypicals, USA TODAY studied the Food and Drug Administration's>Adverse Event Reporting System database.>> The database collects mandatory reports from manufacturers and>voluntary reports from health professionals and consumers describing>adverse drug reactions.>> It uses the information to look for potential safety problems worthy>of investigation. It includes information on the patient's age and>gender, medications, symptoms and outcome. The data cannot be used to>prove that a particular drug caused an adverse event, but the agency>does label which drugs were considered the "primary" or "secondary">suspects.>> USA TODAY's analysis focused on 1,373 cases received by the FDA from>2000 to 2004 in which one of the six atypical anti-psychotic drugs was>coded as the primary suspect. These cases were used to count symptoms,>diagnoses and deaths.>> To learn about patterns in atypical use, USA TODAY asked Medco>Health Solutions, a prescription-drug benefit manufacturer, to query>its member database.>> The company provided sample data on rates for atypical and>non-atypical anti-psychotic prescriptions and other topics.>> Finally, USA TODAY obtained data on pediatric atypical prescriptions>from California and Illinois under Freedom of Information requests.>>By Marilyn Elias, USA TODAY> 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 antipsychotics> & mdash; drugs approved only for adults & mdash; finally stabilized>a's moods. Now at 15, she is able to live a more normal life> & mdash; as long as she takes the medication.>>Even so, the ville, Mo., teen is paying a price: On one of the>atypical antipsychotics, 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 antipsychotic drugs approved by the>Food and Drug Administration for adult schizophrenia and bipolar>disorder (manic depression). None of the six drugs & mdash; Clozaril,>Risperdal, Zyprexa, Seroquel, Abilify and Geodon & mdash; 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 antipsychotics.>>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 antipsychotic 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 antipsychotic 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.>>Antipsychotics 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 & mdash; from just under half a million to about 2.5>million & mdash; 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 & mdash; 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 & mdash; misspellings>and all & mdash; 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:>> & bull; 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.>> & bull; 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.>> & bull; 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 & mdash; 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 antipsychotic, 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 antipsychotics 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 antipsychotics. "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 antipsychotics, she'd disintegrate.">>But several factors can lead to misprescribing of antipsychotics.>>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 antipsychotic>drugs, he says.>>Insurance coverage rules may encourage the soaring use of>antipsychotics 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 antipsychotic 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.">