Pregnancy Risk Categories

Special Note

[effective June 30, 2015]

FDA published a Pregnancy and Lactation Labeling Rule to assist HCPs in assessing medication use benefit vs. risk in pregnant women and nursing mothers; pregnancy letter categories (A, B, C, D, X) will be removed from all Rx medications and package inserts will be required to be updated when pregnancy/lactation info is outdated; OTC products will not be affected by this rule

Category A

[generally considered safe]

controlled studies show no risk in 1st trimester; no evidence of 2nd or 3rd trimester risk; risk of fetal harm remote

Category B

[caution advised]

animal studies show no risk or adverse fetal effects but controlled human 1st trimester studies not avail/do not confirm; no evidence of 2nd or 3rd trimester risk; fetal harm possible but not likely; see pkg insert for drug-specific recs

Category C

[weigh risk/benefit]

animal studies show adverse fetal effect(s) but no controlled human studies OR no animal or human studies; weigh possible fetal risk vs. maternal benefit; see pkg insert for drug-specific recs

Category D

[weigh risk/benefit]

positive evidence of human fetal risk; maternal benefit may outweigh fetal risk in serious or life-threatening situations; see pkg insert for drug-specific recs

Category C/D/D

[weigh risk/benefit]

category C in 1st trimester but positive evidence of human fetal risk in 2nd and 3rd trimesters; maternal benefit may outweigh fetal risk in serious or life-threatening situations; see pkg insert for drug-specific recs

Category X

[contraindicated]

positive evidence of serious fetal abnormalities in animals, humans, or both; fetal risks clearly outweigh maternal benefit