Stimulant use was significantly associated with sudden, unexplained deaths in children and adolescents in a study of more than 500 children, but the data are not sufficient to change clinical prescribing practices, Food and Drug Administration officials said in a press briefing.
“It's hard to characterize the results as reassuring, but we didn't find them threatening,” said Dr. Robert Temple, director of the Office of Drug Evaluation I at the agency's Center for Drug Evaluation and Research.
Previous studies suggest that stimulants increase the risk of cardiovascular events, including sudden death, in children who are already at risk for heart problems, Dr. Temple said.
But few data exist on the impact of stimulant use in children without known underlying risk factors, he noted.
In this study, Madelyn S. Gould, Ph.D., of Columbia University in New York, and her colleagues compared stimulant use in 564 children aged 7-19 years who died suddenly from no known health problems, with stimulant use in 564 children aged 7-19 years who died as passengers in motor vehicle accidents.
Accident victims were chosen because they provide a control population of children who died suddenly and whose death was not caused by a known health problem. Children with a known history of heart problems were excluded from the study (Am. J. Psychiatry 2009 June 15 [doi: 10.1176/appi.ajp.2009.09040472]).
The researchers found that 10 (1.8%) children who died suddenly of unexplained causes were taking stimulants, compared with 2 (0.4%) children who died suddenly in car accidents. This difference was statistically significant after controlling for multiple variables, but the study was limited by several key factors, including a lack of complete postmortem blood work on the car accident victims, the researchers wrote.
A case-control study cannot prove causality, Dr. Temple added. “The reason for our cautious interpretation is that everything depends on whether the people who died were or were not taking an amphetamine,” he said, adding that the researchers depended primarily on the memories of people involved with the accident victims.
“We were unable to conclude that the data affect the overall risk and benefit profile of the stimulant medications,” said Dr. Temple.
He advised clinicians who treat children with stimulants to adhere to the current labeling recommendations and to monitor the children closely. “We continue to advise people to look at these children for any evidence of an underlying cardiac disease.”
To view the full study, go to www.ajp.psychiatryonline.org/cgi/reprint/appi.ajp.2009.09040472v
The study was cofunded by the FDA and the National Institute of Mental Health. Dr. Gould had no financial conflicts to disclose.