A drug for which animal studies have failed to demonstrate a risk to the fetus and in which no adequate studies in pregnant women have been found would fall into which U.S. Food and Drug Administration (FDA)pregnancy risk category?

Question

Quizplus · Accepted Answer

Correct: For category B, animal studies have failed to demonstrate a risk to the fetus, and there are no adequate studies in pregnant women; or animal studies show an adverse effect on the fetus, but well-controlled studies in pregnant women have failed to demonstrate a risk to the fetus. For category A, adequate studies have been performed in humans and animals without demonstrating fetal risk.
Incorrect choices: Category A is the safest, and category X should not be used in pregnant women. Categories B, C, and D fall in between these two.

A Drug for Which Animal Studies Have Failed to Demonstrate