A matched, case-control analysis demonstrated an association between the use of stimulant medications (used to treat attention-deficit/hyperactivity
disorder [ADHD]) and sudden unexplained death in children and adolescents.
Investigators assessed mortality data and death certificates from 1985 through 1996 from state vital statistics offices to
obtain information about cases of sudden unexplained death in patients aged 7 to 19 years. Autopsy and toxicology reports
were obtained when possible, and parents were approached for surveys and consent. Investigators then matched the sudden unexplained
death cases with cases of pediatric patients who died as passengers in motor vehicle accidents to serve as a comparison group.
The primary exposure variable was evidence of stimulant use immediately before death, as noted by informants or in medical
examiner records, toxicology reports, or death certificates.
The final analysis included 564 cases of sudden death; these cases were matched with 564 comparison cases. Stimulant use was
identified in 10 of the 564 unexplained death cases (1.8%) and 2 of the comparison cases (0.4%; OR=7.4; 95% CI, 1.4–74.9;
P=.02).
The authors discussed several limitations to their study, including the long interval between date of death and informant
survey, which could have led to recall bias. The authors stated that healthcare professionals are more likely to ask questions
about medication use in the case of sudden unexplained death. Finally, the investigators observed differences in toxicologic
assays and other tests across cases, which may have led to differences in measurements of drug exposure. FDA discussed these limitations in a communication regarding an ongoing safety review. FDA stated, "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 agency recommended that treatment decisions should not be based
on the results of this study, but that parents should discuss their concerns with healthcare professionals.
SOURCE
Gould MS, Walsh BT, Munfakh JL, et al. Sudden death and use of stimulant medications in youths. Am J Psychiatry. June 2009 [Epub ahead of print].
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