Stimulant Medications for ADHD: Ongoing Safety Review Assessing the Potential Association With Sudden Death in Children - June 2009

The Food and Drug Administration (FDA) has released a statement concerning the findings of a recent retrospective study on the possible association between stimulant medication use and sudden death in children. In this study, 564 previously healthy children who died suddenly in motor vehicle accidents were compared to a group of 564 previously healthy children who died suddenly. Two of the 564 (0.4%) children in motor vehicle accidents were taking stimulant medications compared to 10 of 564 (1.8%) children who died suddenly. While the authors of this study conclude there may be an association between stimulant use and sudden death in children, there were a number of limitations to the study and the FDA cannot conclude this information impacts the overall risk/benefit profile of these medications.

Parents are instructed not to discontinue a child’s stimulant medication based upon this information and should discuss the issue with the prescriber. If a child displays symptoms of cardiovascular disease including chest pain, dyspnea or fainting, parents should seek immediate medical care for the child.

Further assessment of the strength of this potential association is ongoing through research conducted by the FDA and the Agency for Healthcare Research and Quality. Data collection will be completed by the end of 2009.

For additional information, refer to http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanM...

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