pregnancy category

Introduction

Safety in pregnancy:

A: safety has been established in human studies. no disclosed fetal effects

B: presumed safety based on animal studies; animal studies suggest fetal risk

C: uncertain safety; animal studies show an adverse effect; no human studies

D: unsafe; evidence of risk that may in certain circumstances be justifiable

X: highly unsafe; risk of use outweighs any possible benefit

+: generally accepted as safe

?: unknown or controversial

-: generally regarded as unsafe

Notes

• FDA will require drug to be labeled with 3 new sections in lieu of the A,B,C,D,X system
  • Pregnancy
  • Lactation
  • Females and Males of Reproductive Potential
• drugs with pregnancy category X should never be given to pregnant or lactating women

More general terms

• pharmacy

Additional terms

• medications during pregnancy
• pregnancy (gestation)