Impact of FDA Risk Communications on Health Care Utilization and Health Behaviors: A Systematic Review

Background: Understanding the intended and unintended outcomes from U.S. Food and Drug Administration (FDA) risk communications may help guide future risk communications. Objectives: To systematically review and summarize the literature on the impact of FDA risk communications. Methods: Searching PUBMED and the Web of Science for manuscripts that included specific concepts ((1) drug utilization, (2) the FDA, and (3) advisories or warnings), we included manuscripts that presented empirical data on the impact of FDA risk communications. From included studies, we extracted the drugs analyzed, relevant FDA communications, data source, analytical method, and outcome measures including: (1) utilization or dispensing, , (2) use of substitutes, (3) spillover effects, (4) diagnoses and non-prescription utilization, (5) health behaviors and health outcomes, and (6) patient or physician knowledge, attitudes or beliefs. Results: Of 1,430 retrieved articles, 46 met our review criteria. Studies focused on 15 medicines or therapeutic classes. Most studies assessed aggregate, rather than patient-level patterns of prescribing. Few studies examined patient-provider communication, decision-making or risk perception. Advisories recommending increased monitoring generally led to decreased drug use. Repeated or sequential advisories tended to have larger effects and decreased incident more than prevalent use. Warnings regarding a specific agent were associated with particularly large decreases in utilization, though the magnitude of substitution varied across clinical contexts. Conclusions: 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.