Regulatory Focus™ > News Articles > Study: FDA's Risk Communications and Warnings Not as Effective as Hoped

Study: FDA's Risk Communications and Warnings Not as Effective as Hoped

Posted 15 June 2012 | By Alexander Gaffney, RAC 

A new meta-analysis in the journal Medical Care looking at the effect of risk communications sent out by the US Food and Drug Administration (FDA) finds an inconsistent response to FDA's attempts to warn the public about the potential harms associated with some medications.

The study looked at 49 studies published between 1990 and 2010 which evaluated the impact of FDA risk communications, including safety alerts, letters to healthcare providers and black box warnings.

"While some FDA drug risk communications had immediate, strong impact, many had either delayed or no impact on health care utilization or health behaviors," the authors concluded. For instance, FDA missives asking for healthcare providers to monitor the use of a drug led to decreased utilization, but often minimal long-term monitoring of symptoms. Warnings against co-prescribing drugs "often took months or years to show an effect," explain the authors, while still other warnings spilled over into the prescribing utilization of other drugs.

"Risk communication is a complex science and understanding the intended and unintended outcomes from prior FDA advisories, and label warnings may help to guide future risk communication," the authors wrote. ""[This] demonstrates the challenge that policy-makers face to design risk messages that are maximally effective, specific, and that don't become risks themselves."


Read more:

FDA Warnings on Drug Risks Don't Always Have Desired Effects

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