[url="http://www.usatoday.com/news/health/2006-05-01-atypical-drugs_x.htm"]http://www.usatoday.com/news/health/200 ... rugs_x.htm[/url]
By Marilyn Elias, USA TODAY
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 antipsychotics — 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 antipsychotics, 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 antipsychotic 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 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.
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 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.
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