FDA Pregnancy Categories Quiz

Questions and Answers

What does CATEGORY A indicate about drug use during pregnancy?

Evidence of risk during the first trimester

No studies have been conducted

Adequate studies in women demonstrated no risk to the fetus (correct)

Animal studies show adverse effects

What does CATEGORY B signify?

Adequate studies have shown risk to the fetus

No adequate studies in women but animal studies show no risk (correct)

Human studies show significant risk

Category B drugs are entirely safe

What risk does CATEGORY C carry?

No risk to fetus

No animal studies conducted

Adverse effects shown in animal studies but no adequate human studies (correct)

Evaluated as safe for any use in pregnant women

What is indicated by CATEGORY D?

<p>There is evidence of human fetal risk, but potential benefits may be acceptable.</p> Signup and view all the answers

What does CATEGORY X indicate?

<p>The risk of use in pregnant women clearly outweighs any possible benefit.</p> Signup and view all the answers

Study Notes

FDA Pregnancy Categories

Category A:
- Adequate studies in women indicate no risk to the fetus during the first trimester.
- No evidence of risk in later trimesters.
Category B:
- Animal studies show no risk to the fetus, yet no adequate studies exist in pregnant women.
- Alternatively, animal studies may indicate an adverse effect, but human studies show no risk in the first trimester and no evidence of risk in later trimesters.
Category C:
- Animal studies demonstrate adverse effects on the fetus, with no adequate human studies available.
- Benefits of the drug may be acceptable despite potential risks, or lacking animal reproduction studies and human data.
Category D:
- There is evidence of human fetal risk.
- Potential benefits of the drug for pregnant women may justify risks.
Category X:
- Studies in animals or humans reveal fetal abnormalities or adverse reactions.
- Evidence indicates that risks of use in pregnant women outweigh any possible benefits, rendering this category unsafe.

Description

Test your knowledge on the FDA pregnancy categories. This quiz covers the definitions and implications of Categories A, B, C, D, and X regarding drug safety in pregnancy. Learn how these classifications affect the use of medications during pregnancy.