What does an FDA pregnancy risk category of 'D' indicate?

An FDA pregnancy risk category of 'D' indicates that there is proven risk of fetal harm based on human data. This classification suggests that studies have demonstrated the potential for negative effects on the fetus when the medication is used during pregnancy, but the potential benefits of the drug may outweigh the risks in certain situations.

This classification is particularly important for healthcare providers when prescribing medications to pregnant individuals. It highlights the necessity of carefully weighing the risks associated with a medication that can adversely affect fetal development against the health benefits it may provide to the pregnant individual. Therefore, while alternative treatments that pose less risk should be considered first, the use of a category 'D' medication might be warranted in critical situations where the pregnant person's health is at significant risk.

The other choices do not accurately reflect what a category 'D' signifies; for instance, a category that suggests a remote risk of harm or no risk does not align with the established understanding that category 'D' reflects evidence of risks to the fetus.