NeLM news service
US FDA issues statement following analysis of cohort study showing ADHD drugs are not associated with serious cardiovascular events

Reference: NEJM, published early online on 1 November 2011

Source: NEJM

Date published: 02/11/2011 16:46

Summary
by: Hina Radia

According to research published early online in the New England Journal of Medicine, children who take stimulants for attention deficit hyperactivity disorder (ADHD) do not have an increased risk of heart attacks, strokes or sudden death.

 

Adverse-event reports from North America have raised concern that the use of drugs for attention deficit–hyperactivity disorder (ADHD) increases the risk of serious cardiovascular events. Researchers conducted a retrospective cohort study with automated data from four health plans(Tennessee Medicaid, Washington State Medicaid, Kaiser Permanente California, and OptumInsight Epidemiology), with 1,200,438 children and young adults between the ages of 2 and 24 years and 2,579,104 person-years of follow-up, including 373,667 person-years of current use of ADHD drugs. The relative risk of serious cardiovascular events (sudden cardiac death, acute myocardial infarction, and stroke) were compared with non-users.

 

The researchers reported that a total of 81 cohort members had a serious cardiovascular event, or 3.1 per 100,000 person-years, including 33 sudden cardiac deaths (1.3 per 100,000 person-years), 9 acute myocardial infarctions (0.3 per 100,000 person-years), and 39 strokes (1.5 per 100,000 person-years). Additionally, as compared with the non-users, the adjusted rate of serious cardiovascular events did not differ statistically significantly among current users of ADHD drugs (hazard ratio, 0.75; 95% confidence interval [CI], 0.31 to 1.85) or among former users (hazard ratio, 1.03; 95% CI, 0.57 to 1.89).

 

The researchers concluded that “the point estimate of the relative risk provided no evidence that the use of ADHD drugs increased the risk of serious cardiovascular events, although the upper limit of the 95% confidence interval was consistent with up to a doubling in the risk.”

 

Separately, the US Food and Drug Administration has issued updated advice regarding stimulants and their use for the treatment of ADHD in children. The FDA states that the results of this study published in the NEJM have not shown an association between use of certain ADHD medications and adverse cardiovascular events. However, the FDA continues to recommend that healthcare professionals prescribe these medications according to the professional prescribing label. However, the FDA advises healthcare professionals that:

 

• Stimulant products and atomoxetine should generally not be used in patients with serious heart problems, or for whom an increase in blood pressure or heart rate would be problematic.

• Patients treated with ADHD medications should be periodically monitored for changes in heart rate or blood pressure.

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