Table 1 |
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FDA pregnancy categories |
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| Category |
Description |
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|
| A |
Adequate and well-controlled studies have failed to demonstrate a risk to the fetus
in the first trimester of pregnancy (and there is no evidence of risk in later trimesters) |
| B |
Animal reproduction studies have failed to demonstrate a risk to the fetus and there
are no adequate and well-controlled studies in pregnant women |
| C |
Animal reproduction studies have shown an adverse effect on the fetus and there are
no adequate and well-controlled studies in humans, but potential benefits may warrant
use of the drug in pregnant women despite potential risks |
| D |
There is positive evidence of human fetal risk based on adverse reaction data from
investigational or marketing experience or studies in humans, but potential benefits
may warrant use of the drug in pregnant women despite potential risks |
| X |
Studies in animals or humans have demonstrated fetal abnormalities and/or there is
positive evidence of human fetal risk based on adverse reaction data from investigational
or marketing experience, and the risk involved in use of the drug in pregnant women
clearly outweighs potential benefits |
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Chambers et al. Arthritis Research & Therapy 2006 8:215 doi:10.1186/ar1977 |
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