TABLE 4.

FDA Pregnancy Categories (not used after 30 June 2015) (30)

Controlled studies in pregnant women have failed to demonstrate a risk to the fetus in the first trimester of pregnancy (and there is no evidence of a risk in later trimesters). Possibility of fetal harm appears remote. 
Animal reproduction studies have not demonstrated a fetal risk, but there are no controlled studies in women, AND the benefits from the use of the drug in pregnant women may be acceptable despite its potential risks.
OR
Animal studies have shown an adverse effect that was not confirmed in controlled studies in women. 
Animal reproduction studies have shown an adverse effect on the fetus, there are no controlled studies in women, AND the benefits from the use of the drug in pregnant women may be acceptable despite its potential risks.
OR
Animal studies have not been conducted, and there are no controlled studies in women. 
There is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience or studies in women, BUT the potential benefits from the use of the drug in pregnant women may be acceptable despite its potential risks. 
Studies in animals or women have demonstrated fetal abnormalities.
OR
There is positive evidence of fetal risk based on adverse reaction reports from investigational or marketing experience or both, AND the risk of the use of the drug in a pregnant woman clearly outweighs any possible benefit. 
Controlled studies in pregnant women have failed to demonstrate a risk to the fetus in the first trimester of pregnancy (and there is no evidence of a risk in later trimesters). Possibility of fetal harm appears remote. 
Animal reproduction studies have not demonstrated a fetal risk, but there are no controlled studies in women, AND the benefits from the use of the drug in pregnant women may be acceptable despite its potential risks.
OR
Animal studies have shown an adverse effect that was not confirmed in controlled studies in women. 
Animal reproduction studies have shown an adverse effect on the fetus, there are no controlled studies in women, AND the benefits from the use of the drug in pregnant women may be acceptable despite its potential risks.
OR
Animal studies have not been conducted, and there are no controlled studies in women. 
There is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience or studies in women, BUT the potential benefits from the use of the drug in pregnant women may be acceptable despite its potential risks. 
Studies in animals or women have demonstrated fetal abnormalities.
OR
There is positive evidence of fetal risk based on adverse reaction reports from investigational or marketing experience or both, AND the risk of the use of the drug in a pregnant woman clearly outweighs any possible benefit. 
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