Recent finding suggest that FDA drug warnings are not always effective and that the result vary greatly.
Researchers across the U.S. examined literature pertaining to the FDA’s drug-risk communication system. Of 1,432 records, 49 were eligible for analysis. To be eligible, studies had to be published between January 1990 and November 2010 and had to evaluate the effect of an FDA risk warning and contain terms associated with drug utilization.
The findings covered 16 medicines or therapeutic classes. Communications for antidepressants comprised one-third of the studies. There was variety in the data sources and statistical analysis methods used, but most of the studies used medical or pharmacy claims, according to Endocrine Today.
According to the results, FDA advisories recommending increased clinical or laboratory monitoring were linked to decreased drug use. However, these advisories were linked to moderate, transient increases in monitoring.
Also on the negative side was that they found that in some cases communication directed at one specific population often demonstrated effect on other populations.
The researchers concluded that the effect of risk communication is varied and unpredictable. They said because the use of risk communication to ensure safe use of medications is complex, it requires consistent evaluation.
One researcher told Endocrine Today the most effective communications were the ones that were “simple, specific, provided alternative therapies or drugs, and were reinforced over time.”