Impact of FDA drug risk communications on health care utilization and health behaviors: a systematic review

Med Care. 2012 Jun;50(6):466-78. doi: 10.1097/MLR.0b013e318245a160.


Objective: To review literature on the impact of The Food and Drug Administration (FDA) drug risk communications on medication utilization, health care services use, and health outcomes.

Data sources: The authors searched MEDLINE and the Web of Science for manuscripts published between January 1990 and November 2010 that included terms related to drug utilization, the FDA, and advisories or warnings. We manually searched bibliographies and works citing selected articles and consulted with experts to guide study selection.

Study selection: Studies were included if they involved an empirical analysis evaluating the impact of an FDA risk communication.

Data extraction: We extracted the drug(s) analyzed, relevant FDA communication(s), data source, analytical method, and main outcome(s) assessed.

Results: Of the 1432 records screened, 49 studies were included. These studies covered 16 medicines or therapeutic classes; one third examined communications regarding antidepressants. Most used medical or pharmacy claims and a few rigorously examined patient-provider communication, decision making, or risk perceptions. Advisories recommending increased clinical or laboratory monitoring generally led to decreased drug use, but only modest, short-term increases in monitoring. Communications targeting specific subpopulations often spilled over to other groups. Repeated or sequential advisories tended to have larger but delayed effects and decreased incident more than prevalent use. Drug-specific warnings were associated with particularly large decreases in utilization, although the magnitude of substitution within therapeutic classes varied across clinical contexts.

Conclusions: Although some FDA drug risk communications had immediate and strong impacts, many had either delayed or had no impact on health care utilization or health behaviors. These data demonstrate the complexity of using risk communication to improve the quality and safety of prescription drug use, and suggest the importance of continued assessments of the effect of future advisories and label changes. Identifying factors that are associated with rapid and sustained responses to risk communications will be important for informing future risk communication efforts.

Publication types

  • Research Support, N.I.H., Extramural
  • Research Support, Non-U.S. Gov't
  • Review
  • Systematic Review

MeSH terms

  • Communication*
  • Drug Interactions
  • Drug Monitoring
  • Drug Utilization / statistics & numerical data*
  • Drug-Related Side Effects and Adverse Reactions
  • Health Behavior*
  • Health Knowledge, Attitudes, Practice
  • Health Services / statistics & numerical data*
  • Humans
  • Patient Selection
  • Risk Assessment
  • Risk Management
  • United States
  • United States Food and Drug Administration / organization & administration*