What does Category B indicate about a drug's fetal risk?

Category B indicates that animal studies have revealed no fetal risk, but this has not been confirmed in human studies. This designation suggests that while animal research did not show negative effects on the developing fetus, comprehensive human testing is lacking or has not provided conclusive evidence regarding safety during pregnancy.

As a result, Category B drugs may often be considered for use during pregnancy when the benefits potentially outweigh any risks, based on the lack of demonstrated harm in animal models. Since Category B indicates that there is no confirmed risk to fetuses in animal studies, it reflects a cautious stance regarding safety in pregnant patients, acknowledging the need for more definitive human data.