FDA's Role

How Does the FDA Communicate Drug Safety Information to the Public?

The FDA has enhanced its efforts to communicate important drug safety issues.

The FDA uses the term “emerging drug safety information” to describe information the FDA is monitoring or analyzing that may have the potential to alter the benefit/risk analysis for a drug in such a way as to affect the decisions about prescribing or taking the drug, but that has not yet been fully analyzed or confirmed.

"Emerging drug safety information" can include both potential and identified risks. To help with this distinction, the FDA identifies the source of information through which drug safety signals are identified. It is important for healthcare providers to evaluate not only the significance of the risk, but also its validity, when making judgments about drug safety.

The FDA uses a broad range of methods to communicate drug safety information to the public. Certain forms of communication are targeted to specific audiences (for example healthcare providers or patients). Others are directed toward more than one group to ensure widespread communication of information about important drug safety issues, including emerging drug safety issues.

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