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?

Question

1. Determine the extent of the safety concern by conducting additional studies
2. Require changes be made to the product's labeling information
3. Recall the product
4. Restrict the product's use in certain populations
5. Continue to log in public concerns regarding the safety of the product before taking further action

Answer 1

Correct Answer: 1,2,3,4
Rationale 1: The FDA will conduct additional epidemiologic studies to determine the validity or extent of the concern.
Rationale 2: The FDA will require the pharmaceutical company to change the product's label to reflect this concern.
Rationale 3: The FDA will recall a product that may have performance concerns.
Rationale 4: The FDA will restrict the product's use in certain populations.
Rationale 5: The FDA will not just continue to log in concerns regarding the safety of the product. At this point, additional studies, additional product labeling, recall, or removal of the product will occur.
Global Rationale: The FDA will conduct additional epidemiologic studies to determine the validity or extent of the concern, require the pharmaceutical company to change the product's label to reflect this concern, recall a product that may have performance issues, and restrict the product's use in certain populations. The FDA will not just continue to log in concerns regarding the safety of the product. At this point, additional studies, additional product labeling, recall, or removal of the product will occur.