title: ADHD medication use following FDA risk warnings.
abstract: 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.
  
  
  OBJECTIVE
  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.
  
  
  CONCLUSIONS
  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.
  
  
  CONCLUSIONS
  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.
  
  
  CONCLUSIONS
  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.
  
  
  CONCLUSIONS
  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.
authors.affiliation: Department of Health Policy and Management, Johns Hopkins Bloomberg School of Public Health, Baltimore MD, 21205, USA. cbarry@jhsph.edu
authors.forename: Colleen L
authors.initials: CL
authors.lastname: Barry
authors.forename: Andres
authors.initials: A
authors.lastname: Martin
authors.forename: Susan H
authors.initials: SH
authors.lastname: Busch
mesh_terms: D000293:Adolescent; D000328:Adult; D001289:Attention Deficit Disorder with Hyperactivity / Q000188:drug therapy* / Q000453:epidemiology; D000697:Central Nervous System Stimulants / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D002648:Child; D002675:Child, Preschool; D004363:Drug Utilization / Q000706:statistics & numerical data*; D005260:Female; D006331:Heart Diseases / Q000139:chemically induced; D006801:Humans; D007223:Infant; D008297:Male; D008402:Mass Media; D001523:Mental Disorders / Q000139:chemically induced; D061214:Patient Safety; D012959:Socioeconomic Factors; D014481:United States; D014486:United States Food and Drug Administration
chemical_list: D000697:Central Nervous System Stimulants