ADHD medication use following FDA risk warnings.

BACKGROUND: In 2006, the U.S. Food and Drug Administration (FDA) investigated cardiac and psychiatric risks associated with attention deficit/hyperactivity disorder (ADHD) medication use.

AIMS OF THE STUDY: To examine how disclosure of safety risks affected pediatric ADHD use, and to assess news media coverage of the issue to better understand trends in treatment patterns.

METHODS: We used the AHRQ's Medical Expenditure Panel Survey (MEPS), a nationally representative household panel survey, to calculate unadjusted rates of pediatric ADHD use from 2002 to 2008 overall and by parents' education. We examined whether children (ages 0 to 20) filled a prescription for any ADHD medication during the calendar year. Next, we used content analysis methods to analyze news coverage of the issue in 10 high-circulation newspapers, the 3 major television networks and a major cable news network in the U.S. We examined 6 measures capturing information conveyed on risk and benefits of ADHD medication use.

RESULTS: No declines in medication use following FDA safety warnings overall or by parental education level were observed. News media coverage was relatively balanced in its portrayal of the risks and benefits of ADHD medication use by children.

DISCUSSION: ADHD risk warnings were not associated with large declines in medication use, and balanced news coverage may have contributed to the treatment patterns observed. Self-reported surveys like the MEPS rely on the recall of respondents and may be subject to reporting bias. However, the validity of these data is supported by their consistency with other data on drug use from other sources.

IMPLICATIONS FOR HEALTH CARE PROVISION AND USE: These findings are in direct contrast to the substantial declines in use observed after pediatric antidepressant risk warnings in the context of a news media environment that emphasized risks over benefits.

IMPLICATIONS FOR HEALTH POLICIES: Our findings are relevant to the ongoing discussion about improving the FDA's ability to monitor drug safety. Safety warnings occur amid ongoing concern that the agency has insufficient authority and resources to fulfill its mission to protect the public's health. Efforts to bolster the FDA's post-marketing surveillance system have the potential to incorporate more data in decision making to allow for earlier detection of health risks.

IMPLICATIONS FOR FURTHER RESEARCH: Further research is needed to assess whether other treatment changes occurred following risk warnings. For example, it is important to determine whether an increase in cardiac screening prior to medication initiation occurred. Likewise, the FDA advises that children experiencing hallucinations or other psychiatric responses to medication be discontinued from drug treatment. If it is determined that instead of being discontinued from medication treatment, children experiencing hallucinations are put on additional medication (e.g., antipsychotics), additional efforts by the FDA to better inform the public are warranted.