ADHD medications may be linked to sudden unexplained death

July 1, 2009

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.

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).

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].