Tag: Pregnancy category b

For years, cefdinir was classified as a pregnancy Category B medication by the FDA, signifying a lack of demonstrated risk to a fetus in animal studies but no controlled human data. However, in 2015, the FDA deprecated this letter-based system and replaced it with a more detailed narrative format under the Pregnancy and Lactation Labeling Rule (PLLR).

While many older medications were once categorized by the U.S. Food and Drug Administration (FDA) with letter grades for pregnancy risk, this system was replaced in 2015. Previously, amoxicillin was indeed categorized as Pregnancy Category B, indicating animal studies showed no risk, but human data was limited.