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Table 14.7. Teratogenicity drug labeling now required by FDA

Table 14-7. Teratogenicity drug labeling now required by FDA.1
Category A: Well-controlled human studies have not disclosed any fetal risk.
Category B: Animal studies have not disclosed any fetal risk; or have suggested some risk not confirmed in controlled studies in women; or there are not adequate studies in women.
Category C: Animal studies have revealed adverse fetal effects; there are no adequate controlled studies in women.
Category D: Some fetal risk, but benefits may outweigh risk (eg, life-threatening illness, no safer effective drug).
Category X: Fetal abnormalities in animal and human studies; risk not outweighed by benefit. Contraindicated in pregnancy.
1The FDA has established 5 categories of drugs based on their potential for causing birth defects in infants born to women who use them during pregnancy. By law, the label must provide available information on teratogenicity.