A client reports an adverse effect to the Adverse Event Reporting System.The nurse recognizes if a potential safety concern is identified,the Food and Drug Administration (FDA)may take which actions?
Select all that apply.

Question

Quizplus · Accepted Answer

If a potential safety concern is identified through the Adverse Event Reporting System, the FDA may take multiple actions including determining the extent of the safety concern by conducting additional studies, requiring changes to the product's labeling information, recalling the product, or restricting the product's use in certain populations. Continuing to log in public concerns is not an action in response to a potential safety concern.

A Client Reports an Adverse Effect to the Adverse Event