title: Messages about black-box warnings: a comparative analysis of reports from the FDA and lay media in the US.
abstract: BACKGROUND
  The US FDA and lay media are important sources of information for the public about the risks of adverse events associated with drugs, yet the quality of FDA and US lay media reports about medication 'black-box' warnings, which highlight potentially severe adverse events from medications, is unknown.
  
  
  OBJECTIVE
  To determine and compare the content of FDA and US lay media reports about medication black-box warnings.
  
  
  METHODS
  We assessed FDA and US lay media reports about medication black-box warnings published or aired between 1 January 2003 and 31 December 2007 for the presence of six core message components, including (i) the affected drug's brand name; (ii) generic name; (iii) treatment indication; (iv) reason for the black-box warning; (v) clinical recommendations for patients, such as warning signs and symptoms of the adverse effect addressed by the black-box warning; and (vi) encouragement to discuss the issue with a healthcare provider, and additional characteristics.
  
  
  RESULTS
  FDA reports presented more core information than lay media reports (median 5 vs 3 message components; p < 0.001). FDA reports were more likely to mention generic names (84.6% vs 18.1%; p < 0.001) of affected drugs, while lay media reports less frequently detailed clinical recommendations for patients (43.9% vs 96.2%; p < 0.001). Only 10.6% of lay media reports encouraged patients to seek additional information from their healthcare provider, compared with 48.1% of FDA reports (p < 0.001).
  
  
  CONCLUSIONS
  FDA and US lay media reports about medication black-box warnings presented different information. This may reflect a difference in underlying motivation for reporting of news about risks of adverse drug events. It may also indicate a lack of agreement and understanding about the best methods to communicate risk information to the public, thus indicating areas for future research.
authors.affiliation: Department of Medicine, Philadelphia Veterans Affairs Medical Center, Philadelphia, Pennsylvania, USA. pyong@nas.edu
authors.forename: Pierre L
authors.initials: PL
authors.lastname: Yong
authors.forename: Cabral
authors.initials: C
authors.lastname: Bigman
authors.forename: David N
authors.initials: DN
authors.lastname: Flynn
authors.forename: Danielle
authors.initials: D
authors.lastname: Mittermaier
authors.forename: Judith A
authors.initials: JA
authors.lastname: Long
mesh_terms: D064420:Drug-Related Side Effects and Adverse Reactions; D006801:Humans; D008402:Mass Media; D015999:Multivariate Analysis; D014481:United States; D014486:United States Food and Drug Administration