The impact of efforts by the U.S. Food and Drug Administration to notify the general public and health care providers about unanticipated risks from approved medications has been "varied and unpredictable," according to a systematic review of published studies about FDA warnings and alerts over the last 20 years.
Although some communication efforts had a strong and immediate effect, many had little or no impact on drug use or health behaviors and several had unintended consequences, researchers report in the journal Medical Care.
"Communicating risk to large groups of people is a complex science," said study director G. Caleb Alexander, MD, associate professor of medicine at the University of Chicago. "But success or failure at this can have significant consequences. As such efforts become more and more common with the FDA's mandate to establish a more active surveillance system we will need a better understanding of how to make them work and where they can go wrong. And we need more and better studies of the successes and failures of this process."
The FDA has several standard tools to disseminate new evidence about drug safety. These include "Dear Healthcare Provider" letters to prescribers, "public health advisories" and "Safety Alerts" targeting the general public, and "black box warnings" added to a label when a drug's risks may be particularly severe or affect a large population. Despite numerous studies examining single alerts, advisories and label changes, no prior study has systematically examined the effect of these risk communications.
The researchers from the University of Chicago Medical Center, North Shore University HealthSystem, Johns Hopkins Medicine and Harvard Medical School combed through the literature on the topic. They screened 1,432 articles published between 1990 and 2010. Only 49 reports had a primary goal of assessing the consequences of FDA risk communications for prescription drugs.
|Contact: John Easton|
University of Chicago Medical Center