"Given the limitations of this study's methodology, the FDA is unable to conclude that these data affect the overall risk and benefit profile of stimulant medications used to treat ADHD in children," the FDA said in a statement released this morning. "Therefore, the FDA believes that this study should not serve as a basis for parents to stop a child's stimulant medication. Parents should discuss concerns about the use of these medicines with the prescribing healthcare professional."
The companies that manufacture these medicines maintain that these products are safe and that their risks are properly disclosed.
"Based on several reviews of these reports, the frequency of sudden cardiac death in children and adolescents taking a stimulant medication at the time of their death has not been shown to be higher than the incidence seen in the general population," Shire Pharmaceuticals, which produces Adderall XR, said in a statement issued Friday before the study's release.
A spokesperson for Novartis, the company that manufactures the ADHD drug Ritalin, said that a review of the company's safety data "failed to detect an increased risk in sudden cardiac death associated with [Ritalin] use." McNeil Pediatrics, the company that manufactures the ADHD drug Concerta, had no comment when contacted by ABC News.
Still, the findings will likely reignite a debate within the medical community over the safety and proper use of the popular medications.
"It is astonishing that these drugs are used so widely with children -- 5 percent of the school-aged population on a daily basis," said William Pelham, professor of psychology, pediatrics and psychiatry at the State University of New York at Buffalo. "When this study is published, I suspect that the professional and advocacy groups that continue to ignore the accumulating evidence showing absence of benefit on long-term outcomes will have a more difficult time defending the widespread practice of using stimulants as first line and sole treatment for ADHD in children."
Other medical professionals said more research is necessary before making any conclusions. "As far as the study design goes, I'm reminded of the old adage that 'correlation is not causation,'" said Jay Reeve, chief executive officer of the mental health services organization Apalachee Center Inc. in Tallahassee, Fla. "The downside of this study may be a wholesale rejection of the use of stimulants for children, which would be terrible.
"While caution is an excellent practice in child psychiatry, too many children are helped by the use of these meds ... to abandon prescribing these meds entirely," he said.
Daniel Cox, professor of psychiatry and neurosciences at the University of Virginia in Charlottesville, agreed, adding that he fears the study will have an overall negative effect on the health of these young patients if the public misinterprets its findings.
"This article cannot address a possible large question: How many lives are saved because of stimulant medications," he said. "How many children do not impulsively run out in the street, are inattentive to a car turning into their lane of traffic, don't climb out on a roof and fall because they are appropriately medicated and less impulsive and inattentive because of the therapeutic effects?"
Still, Ann Hohmann said that the circumstances behind her son's death are hard to ignore.