Volume 12, Number 11—November 2006
Perspective
Prophylaxis and Treatment of Pregnant Women for Emerging Infections and Bioterrorism Emergencies
Joanne Cono*
, Janet D. Cragan*, Denise J. Jamieson*, and Sonja A. Rasmussen*
, Janet D. Cragan*, Denise J. Jamieson*, and Sonja A. Rasmussen*
Table 1
US Food and Drug Administration use-in-pregnancy drug classifications (21 CFR 201.57)
| Category | Description |
|---|---|
| A | Well-controlled studies in humans fail to demonstrate fetal risk. |
| B | Human risk is relatively unlikely because of negative results in animal studies and no human studies, or positive results in animal studies and negative results in human studies. |
| C | Human fetal risk is unknown; positive results in animal studies (or no animal studies) and no human studies. |
| D | Evidence of human fetal risk; however, drug benefits may outweigh risks. |
| X | Positive results in animal studies or evidence of human fetal risk; use in pregnant women is contraindicated. |
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