Impotence Treatment Drugs

ADHD Medication

There does not appear to be an increased risk of cardiovascular events in children and teens taking attention-deficit/hyperactivity disorder (ADHD) medications, researchers found.

Compared with those who did not take the stimulant medications, users did not have a greater risk of sudden death or ventricular arrhythmia (0.06 versus 0.04 per 10,000 person-years; HR 1.60, 95% CI 0.19 to 13.60), according to Sean Hennessy, PharmD, PhD, of the University of Pennsylvania in Philadelphia, and colleagues.

Users also did not have a greater risk of dying from any cause (1.79 versus 3.00 per 10,000 person-years; HR 0.76, 95% CI 0.52 to 1.12), the researchers reported online ahead of the June issue of Pediatrics.

Rates of validated stroke and MI were too low to perform comparisons between the users and nonusers. Although the findings did not identify a difference in cardiovascular risk, the authors noted that, "because of the low number of events, we have limited ability to rule out relative increases in rate." Case reports of sudden death in children and adolescents taking stimulant medications fueled concerns about a possible increased risk of cardiovascular events with the drugs, although previous studies exploring the issue have yielded mixed results.

In 2006, the FDA mandated changes to the labels of all stimulant medications to carry a warning about such a risk. The warning read, "Sudden death has been reported in association with CNS stimulant treatment at usual doses in children and adolescents with structural cardiac abnormalities or other serious heart problems." Earlier this year, the agency announced that preliminary results of studies sponsored by the FDA and the Agency for Healthcare Research and Quality did not indicate the need for stronger warnings.

In the current study, Hennessy and his colleagues used data from two administrative databases -- a Medicaid database and a HealthCore Integrated Research Database.

Children and teens ages 3 to 17 who had a prescription for an ADHD medication -- an amphetamine, atomoxetine, or methylphenidate -- were matched with up to four nonusers by data source, gender, state, and age. The researchers validated cardiovascular events identified through claims by reviewing medical records whenever possible.

Overall, there were 241,417 users of ADHD medications who had at least 180 days of observation before their first recorded prescription. They were matched with 965,668 nonusers.

Because follow-up of users included only the period when there was an active prescription, the median follow-up duration was shorter than in nonusers (135 versus 609 days).

During follow-up, there were 71 hospital and 212 emergency department claims for sudden death or ventricular arrhythmia, 142 hospital claims for stroke, and 25 hospital claims for MI for both users and nonusers. Researchers were able to retrieve medical records to validate about half of the events.