Cardiac Risk Assessment before Stimulant Medication Use
4 November 2009: A new screening tool for physicians to identify potential cardiac risk factors for sudden death in children starting stimulant medication is included in the joint position paper on cardiac risk assessment before the use of stimulant medications in children and youth published this month by the Canadian Paediatric Society, the Canadian Cardiovascular Society and the Canadian Academy of Child and Adolescent Psychiatry. (J Can Acad Child Adolesc Psychiatry 18:4 November 2009).
CADDRA Response to Sudden Death and Use of Stimulant Medications Study
The authors of “Sudden Death and Use of Stimulant Medications in Youths”, published online on June 15th by the American Journal of Psychiatry, concluded there may be an association between the use of stimulant medications and sudden death in healthy children. The article by Madelyn Gould, PhD, M.P.H. and coauthors is available online.
CADDRA clinicians have reviewed the study and have concluded that there is insufficient evidence to indicate a need to change practice with respect to medication use for ADHD.
The psycho stimulant drugs included in the study currently carry warnings about possible increased risk of cardiac events or death in children with underlying heart conditions. Despite this newly published report, the medical consensus based on available research is that these medications do not present a risk to young patients with no known heart disease or risk factors for sudden death.
CADDRA does not recommend a change in practice regarding prescribing or risk assessment, which can be done by the prescribing physician. Routine assessment by a cardiologist before beginning ADHD treatment is not considered necessary by our Board.
Study Summary and Findings
The study was partially funded by the Food and Drug Administration (FDA) but, according to agency experts, its methods - which relied on interviews with parents years after a child's death - may have caused errors. It warns that the low frequency of stimulant use in both groups, as well as possible difference in the type of post-mortem inquiry, could have a profound biasing effect on the result. The agency urges parents to discuss safety concerns with their doctor, but to keep children on the treatments. The FDA is collecting data for a larger, more in-depth study of the drugs' risks.
An accompanying editorial published in the AMJ by Benedetto Vitiello, M.D., and Kenneth Towbin, M.D. noted that while the study underscores the fact that “stimulants are not innocuous and that their therapeutic use requires careful diagnostic assessment, diligent safety screening, and ongoing monitoring … it is equally clear that 1) sudden unexplained death is a rare event, 2) this is only the first such study, 3) it relies on small numbers, and 4) it is not possible to quantify the risk beyond estimating that it is very small”.
CADDRA endorses the joint position statement currently being produced in response to the new study by the Canadian Pediatric Society, the Canadian Cardiovascular Society and the Canadian Academy of Child and Adolescent Psychiatry: Cardiac risk assessment prior to the use of stimulant medications in children and youth.
As the American Association of Child and Adolescent Psychiatrists points out in a statement for members: “Using the metrics of evidence-based medicine for describing the benefit to risk ratio, it only takes two children to show that stimulants have beneficial effects on the symptoms of ADHD, but it requires treating 250,000 children before one might encounter sudden unexpected death associated with stimulant treatment.”
CADDRA urges its members to continue to adhere to The American Academy of Pediatrics/American Heart Association recommendations from May 2008:
To date, Health Canada has not issued any new advisory to physicians on prescribing stimulant medication since the release of the new research data published in the AJP.
CADDRA is a national, Canadian alliance of professionals working in the area of ADHD who are dedicated to world class research, education, training and advocacy. Our board members are leaders in the field and conduct research, treat patients and design practice guidelines for treating ADHD in Canada.
Chair, Canadian ADHD Resource Alliance (CADDRA)