Sixty-four percent of children with autism spectrum disorders took at least one, and 35% took multiple, psychotropic medications in a national sample of more than 33,000 children with autism spectrum disorders, according to a report published online Oct. 21 in Pediatrics.
Approximately 15% of the children given multiple psychotropic agents took three or more classes of the drugs. Polypharmacy was not uncommon even in the very youngest children, occurring in 33% of those aged 2-10 years and in 10% of babies aged 1 year old or younger, said Donna Spencer, Ph.D., who works for a company that provides analytics, technology, and consulting services in Eden Prairie, Minn., and her associates.
These findings are alarming given the scant evidence that these drugs are safe or effective during childhood, "when developing brains and bodies may be particularly vulnerable to environmental or biological influences," the investigators noted.
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A new study shows 64 percent of autistic children are given prescriptions for psychotropic medications.
"Our study underscores an immediate need to develop standards of care around the prescription of psychotropic medications based on the best available evidence and a coordinated, multidisciplinary approach to improving the health and quality of life of children with [autism spectrum disorders] and their families. It [highlights] the need for rigorous trials of psychotropic medications for children with [autism spectrum disorders] and other psychiatric disorders to assess the value of these medications when weighed against their potential for harm," Dr. Spencer and her colleagues said.
Rates of psychotropic drug use are reportedly increasing among children in general and among those with autism specifically, but to date studies have not yielded accurate estimates of use because they’ve been flawed by small sample sizes, reliance on parent reports, and assessment of very short time periods. Current estimates of the proportion of autistic children who receive the drugs vary dramatically, from 27% to 83% in different studies.
To get a more accurate estimate, the researchers performed a retrospective observational study using a claims database for a large U.S. commercial health plan. They identified 33,565 children across the country who were aged 0-20 years, had autism spectrum disorders, and were enrolled in the health plan for a mean of 44 months during the 8-year study period.
A total of 21,334 (64%) of the patients were given at least one prescription for psychotropic drugs, and 11,598 (35%) were given multiple prescriptions for more than one class of psychotropic drugs. In the latter group, the average number of "episodes" of polypharmacy was 5.6, and the average number of days of polypharmacy was 525.
Approximately 20% of the children given polypharmacy filled prescriptions for two classes of drugs, 10% for three classes, and 5% for four or more classes. Common class combinations were antidepressants and [attention-deficit hyperactivity disorder] medications (38% of subjects); antipsychotics and ADHD medications (28%); antipsychotics and antidepressants (20%); and antipsychotic, antidepressant, and ADHD medications (18%), the investigators said (Pediatrics 2013 Oct. 21 [doi:10.1542/peds.2012-3774]). Forty-five percent or about 15,000 of the patients with autism spectrum disorders had visited a psychiatrist, and 85% of those patients had "any psychotropic use," the investigators said.
The factor most strongly associated with both the use of any psychotropic drugs and the use of multiple psychotropic drugs was comorbidity, particularly comorbid seizures, ADHD, bipolar disorder, anxiety, or depression. More white children and more children aged 11 years or under received psychotropic agents as well as multiple psychotropic agents, Dr. Spencer and her associates reported.
The investigators cited several limitations. For example, administrative claims data are not able to capture whether the patient actually took the medication or whether they did so as directed. In addition Dr. Spencer and her colleagues did not examine dose or appropriateness of dose for particular children because "dosing often depends on a child’s weight." This omission might have led to an overestimation of psychotropic use and polypharmacy in cases in which medications were tapered but still prescribed.
Nevertheless, Dr. Spencer and her associates said the study shows that primary care providers must elicit medication histories carefully and monitor patients’ symptoms to make sure that the medications are effective.
This study was supported by the National Institute of Mental Health. No relevant financial conflicts were reported.