PEDIATRICS Vol. 119 No. 2 February 2007, pp. 409-410 (doi:10.1542/peds.2006-3213)
LETTER TO THE EDITOR |
Stimulants and Sudden Death: What Is the Real Risk?: In Reply
Timothy Wilens, MDJoseph Biederman, MD
Thomas J. Spencer, MD
Jefferson Prince, MD
Pediatric Psychopharmacology Unit
Massachusetts General Hospital
Harvard Medical School
Boston, MA 02114
Dr Furman questions whether the actual rates of catastrophic events of children/adolescents on stimulants was a massive underestimate (eg, 90%–99% underestimate) and concludes that, given biological plausibility, there is likely an elevated risk for sudden death associated with stimulants, particularly with underlying undiagnosed cardiovascular deficits. Although Dr Furman uses as basis for her argument the rates of underreporting associated with medications used for depression, suicidality as the adverse event in a disorder in which suicidality is also a symptom seems to be an overinterpretation. In fact, in our estimates of the risk for sudden death associated with stimulants, we used the established rate of underreporting of serious adverse medical events that was derived from a systematic study published in Lancet.1 That study, which used prescription-event monitoring data obtained for 15 newly marketed drugs in the United Kingdom, found that 53% of serious adverse drug reactions were, in fact, reported. Overall, serious events were 5 times more likely to be reported than nonserious events. Thus, given that the rates of sudden death for those on stimulants adjusted for underreporting remain at or below the risk for sudden death in the general population,2 no association has been established. As we stated in our article,2 we continue to recommend that practitioners follow the guidelines set forth by the American Heart Association3 to monitor for possible cardiac symptoms in their patients.
In regards to comments on our disclosures of potential conflict with the article, as both authors comment, the purpose of disclosure is to allow readers to balance the information presented against potential bias of the writer(s). The vast majority of pharmaceutical-based work in which we are involved, as demonstrated in our publications, includes consultation or examination of large data sets for evidence of safety and efficacy, new medication development, and curricula development related to understanding attention-deficit/hyperactivity disorder and its treatment. Although we believe in transparency to ensure that any potential conflict is disclosed, we are all also clinicians directly involved in the care of a large number of children and adolescents with attention-deficit/hyperactivity disorder and have a 20-year history of addressing vexing clinical dilemmas in the field. We certainly appreciate firsthand that hysteria and misinformation all too often produce impediments to treatment that can lead to poor outcomes.
REFERENCES
- Heeley E, Riley J, Layton D, Wilton LV, Shakir SA. Prescription-event monitoring and reporting of adverse drug reactions. Lancet. 2001;358 :1872 –1873[CrossRef][Web of Science][Medline]
- Wilens T, Spencer T, Prince J, Biederman J. Stimulants and sudden death: what is a physician to do?
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[Abstract/Free Full Text] - Gutgesell H, Atkins D, Barst R, et al. Cardiovascular monitoring of children and adolescents receiving psychotropic drugs.
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PEDIATRICS (ISSN 1098-4275). ©2007 by the American Academy of Pediatrics
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