Safety Review of Medications for Attention-Deficit/Hyperactivity Disorder (ADHD) December 2011
The U.S. Food and Drug Administration (FDA) issued updated information regarding the safety of medications for attention-deficit/hyperactivity disorder (ADHD) in adults. The communication was prompted by the results of two epidemiologic studies which failed to show an increased risk of serious cardiovascular events, including myocardial infarction (MI), sudden cardiac death (SCD), and stroke, in adults who received certain medications for ADHD.
The retrospective, population-based cohort studies involved 443,198 adults (aged 25-64 years), of which 150,359 received certain ADHD medications and were matched to 292,839 nonusers (1 user to 2 nonusers). Exposure was based on electronic pharmacy records of filled prescriptions at various study sites. Current ADHD use was a median of 0.33 years and follow-up was a median of 1.3 years per person. The results found no evidence of an increased risk of MI, SCD, or stroke associated with the use of ADHD medications. Specifically, the adjusted rate ratio (RR) of serious cardiovascular events for current use compared with nonuse was 0.83 (95% CI: 0.72-0.96) (Habel, 2011).
Previously, in November 2011, the FDA communicated safety information following results of a study in children and young adults exposed to certain ADHD medications which also failed to show an association of adverse cardiovascular events (SCD, MI, and stroke) and ADHD use in that population. That retrospective cohort study included >1 million patients (aged 2-24 years) and >2 million person-years of follow-up. When compared to patients who did not receive ADHD medications, neither current (adjusted hazard ratio: 0.75; 95% CI: 0.31-1.85) or former (adjusted hazard ratio: 1.03; 95% CI: 0.57-1.89) users of ADHD medications experienced an increased rate of serious cardiovascular events (Cooper, 2011).
ADHD medications involved in these safety reviews were atomoxetine, dexmethylphenidate, dextroamphetamine, dextroamphetamine and amphetamine, lisdexamfetamine, methamphetamine, methylphenidate, and pemoline (no longer marketed).
Product labeling should continue to be followed. In general, stimulant medications and atomoxetine should not be used in patients with serious heart problems or in patients who should avoid increased blood pressure or heart rate; monitor patients for blood pressure or heart rate changes.
For more information, please refer to the following websites:
December, 2011 (adult information):
http://www.fda.gov/Drugs/DrugSafety/ucm279858.htm
November, 2011 (children and young adult information):
http://www.fda.gov/Drugs/DrugSafety/ucm277770.htm