Which of the following describes FDA pregnancy category D?

FDA pregnancy category D is characterized by evidence of human fetal risk, but it is acknowledged that the potential benefits of using the medication may outweigh these risks in certain situations. This category implies that there is substantial data from human studies indicating potential adverse effects on the fetus, but in cases where the condition being treated is severe enough, a healthcare provider may determine that the benefits of treatment could justify the risks involved.

This categorization is critical for healthcare professionals when considering drug therapy in pregnant patients, allowing them to make informed decisions based on a careful assessment of the risks and benefits. In contrast, other categories have different implications regarding safety and risks, such as those indicating no evidence of harm or that the medication is contraindicated in pregnancy. Thus, the correct understanding of category D emphasizes the importance of weighing risks against benefits during clinical decision-making.