FDA Drug Side EffectsWarnings Not Always Effective

Recent research reveals that U.S. Food and Drug Administration (FDA) drug safety warnings are not always effective.

The study, published in the journal, Medical Care, involved researchers from a number of U.S. locations and reviewed literature on the agency’s drug-risk communication system, said Endocrine Today. The team found that results varied widely.

Of 1,432 records considered, 49 were eligible for review. Eligibility included studies published January 1990 – November 2010 that empirically reviewed the FDA risk communication’s effect and contained terms about drug utilization, the agency, and advisories or warnings, said Endocrine Today. Information on drug(s) analyzed, pertinent FDA communications, data sources, analysis method, and outcome measures were also assessed.

G. Caleb Alexander, MD, associate professor of medicine at the University of Chicago, and the study’s lead, also told Endocrine Today that four risk communication types were reviewed. “Warnings about serious adverse events, recommendations against use in specific patient populations, cautions regarding drug-drug interactions, and calls for increased laboratory or clinical monitoring.”

“Drivers of drug use exist within a sea of information,” Alexander said. “Predicting whether a risk communication will be effective is difficult, as our results indicate,” he added, wrote Endocrine Today. Alexander noted that the most effective communications were “simple, specific, provided alternative therapies or drugs, and were reinforced over time.”

The study looked at 16 medicines or therapeutic classes; one-third of the communications involved antidepressants. While various data sources and statistical analysis methods were used, the majority used medical or pharmacy claims; “patient–provider communication, decision-making, or risk perceptions” were reviewed in less studies, said Endocrine Daily. “The data sources we were using were so varied that it was difficult to perform quantitative analyses,” Alexander told Endocrine Today.

Researchers also noted that while many FDA warnings recommend against specific patient groups using specific drugs, wrote Medical Daily, sometimes, other, unexpected results were achieved. When the agency issued warnings about antidepressants in children and teenagers, the use of these medications also dropped in adults.

“Communicating risk to large groups of people is a complex science,” said Alexander,. “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,” he added, wrote Medical Daily.

Alexander and the team concluded that effective risk communication is not always about reducing a drug’s use, but that “The ultimate goal is to cause more informed decision-making…. An advisory or communication may be effective, even though no changes in use of the drug occur,” he said, wrote Endocrine Today.

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