The FDA's adverse event reporting system is known to capture only between 1% to 10% of side effects and deaths, which means the true numbers are actually much higher.
An 8-year-old boy died of cardiac arrest. A 15-year-old boy died of an overdose and a 13-year-old girl experienced diabetic ketoacidosis, a deficiency of insulin. The youngest child was 4, with symptoms that indicated diabetes complications.
The most common adverse reactions reported were:
A condition known as dystonia, which produces involuntary, and often painful muscle spasms, was the most common side effect with 103 cases.
The neuroleptic malignant syndrome showed up in 41 children, and was the most troubling side effect, according to child psychiatrist Joseph Penn, of Bradley Hospital and Brown University School of Medicine, because it can kill within 24 hours.
Atypical antipsychotics are a relatively new class of drugs approved by the FDA for the treatment of adult schizophrenia and bipolar disorder. None of the drugs that include Clozaril, Risperdal, Zyprexa, Seroquel, Abilify and Geodon, are approved for children, but doctors continue to prescribe the drugs off-label for unapproved uses.
Even thought the package inserts for atypicals say their safety and effectiveness with children have not been established, a skyrocketing number of prescriptions are being written for children diagnosed with attention deficit disorder or other behavioral problems, according to a study in the March-April 2006, edition of the journal Ambulatory Pediatrics.
This study found that the number of children prescribed antipsychotic drugs had increased five-fold between 1995 and 2002, to an estimated 2.5 million, which represents an increase from 8.6 for every 1,000 children in the mid-1990s, to nearly 40 in every of 1,000 in 2002.
The researchers analyzed data on children with an average age of 13, who were involved in annual national health surveys involving prescriptions issued during 119,752 doctor visits, and determined that over half of the prescriptions were written for attention deficit or other non-psychotic conditions.
The findings are troublesome "because it looks like these medications are being used for large numbers of children in a setting where we don't know if they work," said the study's lead author, Dr William Cooper, a pediatrician at Vanderbilt Children's Hospital in Nashville, TN.
Back then they found that 43% of prescriptions were written for ADHD, or a related disorder as the primary diagnosis, and 14% were written for bipolar disorder, and 9% for schizophrenia or other psychotic conditions.
In a later nationwide study, researchers concluded that 6 million prescriptions for atypicals were written for children between 1995 and 2002, and again found that a large percentage of the prescriptions were written with ADHD as the primary diagnosis.