The U.S. Food and Drug Administration (FDA) urged caution on interpreting the findings from a new study published on Monday that showed an increase in the risk of sudden death in children who taking common medications used to treat attention deficit disorder (ADHD).
“The FDA believes that this study should not serve as a basis for parents to stop a child’s stimulant medication,” the FDA warned.
“Parents should discuss concerns about the use of these medicines with the prescribing health-care professional.”
The warning comes after the publication of a study that showed out of the 564 children who had died suddenly from heart complications or unknown causes, 10 children (or 1.8%) were taking stimulant medications, a figure significantly higher than the 2 children in the control group who died in car accidents. Stimulant medications in children are most commonly prescribed for ADHD.
“Given the limitations of the study’s methodology, we are unable to conclude that these data affect the overall risk and benefit profile of stimulant medications used to treat ADHD in children,” said Robert Temple, M.D., of the FDA’s Center for Drug Evaluation and Research in a conference call with reporters. The low use of stimulants in both groups may have affected the results. The FDA also expressed concern about inaccuracies in recording drug use by the children.
Attention-deficit stimulant medications already carry the strongest government label, warning users who take the medication about sudden death and cardiac risks.
Popular timulant medications used to treat ADHD in children and teens include such drugs as Shire’s Adderall and Novartis’ Ritalin. The drugs have previously been approved as both safe and effective in the treatment of ADHD in children by the FDA, and remain so despite the latest study.
The American Heart Association recommended last year that doctors should routinely order electrocardiograms (ECGs) before starting children with ADHD on stimulant medications. They also called for future studies to assess the risk of sudden death.
The agency said it will release a more definitive study on the potential risk later this year.
“Although sudden unexplained death is a rare event, this finding should be considered in the context of other data about the risk and benefit of stimulants in medical treatment,” the authors of the study noted.
The findings were published today in the June 15 issue of the American Journal of Psychiatry.
Source: American Journal of Psychiatry and the U.S. Food and Drug Administration