FDA Pregnancy Categories Quiz
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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.

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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.

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