In animal studies, amoxicillin has shown no teratogenicity, but there are no controlled data in human pregnancies. What FDA Pregnancy Category does amoxicillin fall under?

• A. Category C
• B. Category A
• C. Category D
• D. Category B

Answer: (D)

Understanding FDA pregnancy categories: how data from animals and humans determine the designation. Category B means animal studies show no fetal risk and there are no adequate, well-controlled studies in pregnant women. The scenario describes amoxicillin showing no teratogenicity in animal studies, with no controlled human data available. That fits Category B. In contrast, Category A would require well-controlled human data showing no risk; Category C involves potential risk based on animal data or lack of human data; Category D indicates proven fetal risk; Category X is contraindicated. So the correct designation is Category B.