Student nurses are learning about the Food and Drug Administration (FDA) pregnancy categories. What is the best information for the nurse educator to include in the lecture?

Question

1. FDA pregnancy categories for individual drugs seldom change once they are established.
2. FDA pregnancy categories are based on clinical human studies.
3. FDA pregnancy categories provide a framework for safe use of drugs in pregnant women.
4. FDA pregnancy category X has been associated with teratogenic effects.
5. FDA pregnancy category C is safe to use during pregnancy.

Answer 1

Correct Answer: 3,4
Rationale 1: FDA pregnancy categories for individual drugs change as new information is obtained.
Rationale 2: Testing drugs on humans to determine their ability to cause birth anomalies is illegal and unethical. Drugs are tested on pregnant animals.
Rationale 3: FDA pregnancy categories provide a guideline for prescribers to help them choose the least teratogenic drug possible.
Rationale 4: FDA pregnancy category X medications should never be given during pregnancy.
Rationale 5: FDA pregnancy category C includes drugs that we do not have sufficient information for in order to determine their safety. This includes about two-thirds of all prescribed medications.
Global Rationale: FDA pregnancy categories provide a guideline for prescribers to help them choose the least teratogenic drug possible. FDA pregnancy category X medications should never be given during pregnancy. FDA pregnancy categories for individual drugs change as new information is obtained. Testing drugs on humans to determine their ability to cause birth anomalies is illegal and unethical. Drugs are tested on pregnant animals. FDA pregnancy category C includes drugs that we do not have sufficient information for in order to determine their safety. This includes about two-thirds of all prescribed medications.