For decades, the U.S. Food and Drug Administration has issued alerts to the medical profession and the public about the dangers of medications on the market.
Now, a review led by a University of Chicago professor of the effectiveness of the alerts has found they have a mixed and unpredictable record.
The study, published in January in the journal Medical Care, concluded that the most effective FDA warnings were those that targeted a single drug. Little changed in the use of a drug when the agency simply called for more monitoring of a drug, according to the study. The study’s senior author is Dr. G. Caleb Alexander, an associate professor of medicine at the U. of C.
Finally, “when the (FDA’s) recommendations are related to decreasing drug interactions, there’s often a delayed response” of 1 1/2 years or longer in some cases, said Stacie Dusetzina, a research fellow at Harvard Medical School in the Department of Health Care Policy and a co-author of the study.
The study, “The Impact of FDA Drug Risk Communications on Health Care Utilization and Health Behaviors: A Systematic Review,” examined the results of 49 previous studies on the effect of the FDA’s alerts on the use of medications.
“I’m surprised at how variable and unpredictable the effects of communications or advisories have been, and a large number of communications appeared to have little or no effect at all,” Alexander said. “There’s no average effect of advisories, because studies are so different in so many ways.”
The study also found that there were spillover effects from the FDA’s recommendations, meaning that if a warning was issued about the use of a drug by one part of the public, then another group of people might also follow the recommendation. That occurred, for instance, when advisories were issued for the use of antidepressants for children and adolescents; adults, too, reduced their use of the drugs.
“I think the review provides a comprehensive understanding of the effects of drug warnings on clinical behavior across a wide variety of clinical examples. I think the review illustrates the fundamental challenges that we face in the promotion of new medical evidence,” said Elaine Morrato, assistant professor at the Colorado School of Public Health at the University of Colorado at Denver.
Alexander noted that the success of an advisory is not necessarily defined by its effect on how often a medication is prescribed.
“Our report is necessary but not sufficient to judge the overall effectiveness of FDA communications,” Alexander said. “The goal of these communications is to improve the quality of the clinical decisions that patients and providers make. An advisory might not change prescribing rates at all but may still have been effective if it better-informed patients and providers.”