ADHD medication use following FDA risk warnings.

Four and one-half million school age children had a diagnosis of attention deficit/hyperactivity disorder (ADHD) in 2006.1 The primary symptoms of ADHD are inattention, hyperactivity and impulsivity, and the condition can lead to difficulties in school, challenges in relationships with peers and family members, and self-esteem problems.2 There are several effective and clinically proven options for treating children with ADHD including medication treatment.3 As of 2007, $2.3 billion was spent on prescription medication to treat the condition.4 Research indicates that use of ADHD medications rose steeply from 1987 to 1996,5 but has leveled off in recent years.6 Recently, concerns have arisen related to cardiac and psychiatric risks associated with ADHD medication use. In February 2005, Health Canada suspended sales of Adderall due to reports of 20 sudden unexplained deaths in children taking the medication. At this time, the FDA issued a statement that there was no conclusive evidence linking stimulant use with cardiac risks. In August 2005, Health Canada returned Adderall to the market with revised warning labels noting that the medication should not be used in patients with structural cardiac abnormalities. In February 2006, the FDA convened its Drug Safety and Risk Management Advisory Committee to make recommendations to the agency on how to research the possible association between ADHD medications and cardiac problems. Controlled trials had failed to show a correlation between these medications and serious heart problems, but there was concern that trials did not include enough patients with an underlying heart issue and did not last long enough to uncover evidence of a connection. The FDA advisory committee voted unanimously to recommend new medication guides and, in an unexpected move, voted 8 to 7 in favor of adding a black box warning to ADHD medications. The next month, in March 2006, a second FDA panel, the FDA Pediatric Advisory Committee, reviewed evidence of a slight increase in risk (1 per 1,000) of psychiatric events including hallucinations and hearing voices in patients with no previous psychiatric problems and recommended new warning labels but not a black box warning. In February 2007, the FDA declined to follow the drug safety advisory committee’s recommendation to issue a black box warning on ADHD medications related to cardiac risks. However, the agency directed manufacturers to develop medication guides to alert patients and providers to both cardiac risks and psychiatric symptoms associated with ADHD medication use. In this study, we considered three research questions. First, did rates of ADHD medication use change after the FDA investigation of cardiac and psychiatric safety risks? Safety concerns about ADHD medications followed on the heels of the much-publicized controversy related to possible links between pediatric antidepressant use and suicidality. Sharp declines in pediatric antidepressant use occurred following the FDA’s release of safety information. Estimates of the magnitudes of these declines ranged from about 20 to 30 percent.7–12 Second, did responses to risk information differ among children with more compared with less educated parents? College-educated parents may have greater access to scientific risk information, and may be more likely to make treatment decisions on the basis of this information compared to other parents. Conversely, more educated parents, with a heightened awareness of the long-term effects of untreated ADHD, may be more reticent to forgo medication for their child. Prior work suggested that, in the case of pediatric antidepressant use, children of college educated parents had more pronounced declines in medication use compared with other parents.13 Finally, in reporting on FDA actions, did the news media emphasize the risks of pediatric ADHD medication use over the benefits? A majority of Americans describe the news media as a critical source of health information,14 and how the news media frames the problem will likely affect how parents and providers respond to safety information.15 One prior study identified a high volume of news coverage regarding FDA disclosure of antidepressant risks,16 and these news stories could have played a role in the drop in antidepressant use. Our interest is in better understanding how news media coverage may have shaped how parents and providers understood the risks associated with ADHD medications.