The nursing instructor teaches student nurses about the Food and Drug Administration (FDA) Pregnancy Categories. What is the best information to include? Note: Credit will be given only if all correct choices and no incorrect choices are selected. Standard Text: Select all that apply
1. Food and Drug Administration (FDA) Pregnancy Category C is safe to use during pregnancy.
2. Food and Drug Administration (FDA) Pregnancy categories provide a framework for safe use of drugs in pregnant women.
3. Food and Drug Administration (FDA) Pregnancy categories for individual drugs seldom change once they are established.
4. Food and Drug Administration (FDA) Pregnancy categories are based on studies using clinical human research trials.
5. Food and Drug Administration (FDA) Pregnancy Category X has been associated with teratogenic effects.
2,5
Rationale 1: Pregnancy Category C is not necessarily safe, it just means that animal studies have shown an adverse effect, but well-controlled studies in pregnant women have not been done.
Rationale 2: Food and Drug Administration (FDA) Pregnancy Categories provide a framework for safe use of drugs in pregnant women.
Rationale 3: Food and Drug Administration (FDA) Pregnancy categories for individual drugs do change based on reported effects on fetuses.
Rationale 4: Food and Drug Administration (FDA) Pregnancy Categories are based on animal studies.
Rationale 5: Food and Drug Administration (FDA) Pregnancy Category X has been associated with teratogenic effects.
Global Rationale: Food and Drug Administration (FDA) Pregnancy Categories provide a framework for safe use of drugs in pregnant women. Food and Drug Administration (FDA) Pregnancy Category X has been associated with teratogenic effects. Food and Drug Administration (FDA) Pregnancy Categories are based on animal studies. Pregnancy Category C is not necessarily safe, it just means that animal studies have shown an adverse effect, but well-controlled studies in pregnant women have not been done. Food and Drug Administration (FDA) Pregnancy categories for individual drugs do change based on reported effects on fetuses.
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