What does FDA pregnancy category B signify for a medication?

FDA pregnancy category B signifies that there are no human risks reported for a medication, but animal studies may have not shown any adverse effects. This category indicates that while controlled studies in pregnant women have not been conducted or are insufficient, animal studies do not demonstrate a risk to the fetus. Thus, it implies that the medication is generally considered safe to use during pregnancy when the benefits outweigh risks, as there are no well-documented human risks associated with it.

Selecting both insufficient studies in pregnant women and adverse effects in animal studies accurately reflects that category B can encompass situations where animal studies are necessary to assess risk, even if the study outcomes appear to suggest safety. Therefore, while this classification does not detail the nature of animal studies, the lack of human risk coupled with the possibility of varied findings in animal testing is encompassed in this decision-making process regarding medication safety during pregnancy.