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At least 45 unexplained child deaths occurred between 2000 and 2004, which the FDA suspects may have been caused by the use of atypical antipsychotic drugs.
Atypical antipsychotic drugs are currently only approved to treat adults suffering from such psychotic illnesses as schizophrenia, bipolar and other mood disorders, and Tourette''s syndrome. However, these drugs are often used to treat other psychiatric disorders for which they are not approved.
This group of antipsychotics includes Clozaril, Risperdal, Geodon, Seroquel, and Zyprexa.
According to reports, children represent the fastest growing population of users of this new class of antipsychotic medications in the United States. This raises concerns among many medical experts since the FDA has not approved atypical antipsychotics for use in children.
Although experts agree that more children are taking atypical antipsychotic drugs, they are still trying to understand why.
Some evidence suggests that the drugs are being commonly prescribed for attention deficit hyperactivity disorder (ADHD). Researchers at Vanderbilt University Medical Center in Tennessee found that 43% of atypical antipsychotic prescriptions written for children were cited for use in the treatment of ADHD or a related disorder.
Officials with pharmacy benefit manager Medco Health Solutions Inc. suggest that ADHD might not be the primary culprit for the growing number of atypical antipsychotic prescriptions. Recent strides in psychiatry are lending credence to the diagnosis of conditions like schizophrenia and bipolar disorder in children – disorders which warrant the use of antipsychotic medications.
Regardless of the disagreement over why more children are taking these drugs, medical professionals share common concerns.
“The bottom line is that we are seeing a huge increase in the use of these medications among children, and we are not sure if they work or if they are safe,” said pediatrician William Cooper. “These drugs have not been tested for many of the indications that they are being used for.”
Medco officials also question the safety of these drugs.
“There is evidence that the risk of diabetes and metabolic disorders from using atypical antipsychotics could be much more severe for pediatric patients than adults, and there is a need for more studies to understand the long-term effects of these drugs on children,” said Medco''s Chief Medical Officer Robert Epstein, MD.