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FDA Preliminary Report: Safety of Stimulant Medications

Clinicians are encouraged to talk to parents about both the benefits and potential adverse effects of stimulants for treating children with ADHD.

An FDA advisory committee recently voted 8 to 7, with one abstention, to recommend that stimulant medications prescribed for attention deficit hyperactivity disorder (ADHD) carry a strong "black box" warning about potential cardiovascular risks. The vote was reported in the February 10, 2006, edition of the Wall Street Journal. The committee also recommended that prescriptions for stimulant medications should include a patient guide that reviews the evidence for potential cardiac risk. The FDA is reviewing the committee’s recommendations.

The advisory panel based its recommendations on data from children younger than 18 years, including reports of 7 sudden deaths associated with methylphenidate use and 12 deaths associated with amphetamine use. Between 1999 and 2003, nonfatal cardiac and cerebrovascular adverse events were reported in 8 children taking methylphenidate and in 18 children taking amphetamine compounds. Some cases involved multiple psychotropic medications; autopsy reports in sudden-death cases revealed underlying congenital heart disease (e.g., hypertrophic cardiomyopathy) in a minority of cases. Details of the adverse-event reports appear in a recent Perspective piece in The New England Journal of Medicine.

Comment: More than 2.5 million children and adolescents are prescribed medications that target symptoms of ADHD; most of these prescriptions are for stimulant medications. Several members of the FDA advisory committee observed that the rare occurrence of cardiac and cerebrovascular events in patients on these medications may be similar to expected rates in the general pediatric population. With the exception of cases associated with known cardiac or other underlying medical conditions, it is not clear whether the adverse events are actually caused by the stimulant medications. The National Institute of Mental Health and the FDA have already initiated case-control and large population-based studies to evaluate a potential association between sudden unexplained death and stimulant medications.

Clinicians who prescribe medications for ADHD are encouraged to talk to parents about both the benefits and potential adverse effects of treatment. When discussing the FDA advisory committee recommendation with parents, clinicians should emphasize the current uncertainty about a clear association between serious adverse events and stimulant medications. An interim strategy might be to assess patients for cardiovascular disease before initiating stimulant therapy. The assessment may include cardiac auscultation, measurement of blood pressure and heart rate, and family history of genetic heart conditions associated with sudden death (e.g., hypertrophic cardiomyopathy and prolonged QT interval). The AAP recommends that clinicians continue to follow AAP guidelines on the assessment and management of ADHD.

— Martin T. Stein, MD

Published in Journal Watch Pediatrics and Adolescent Medicine April 7, 2006