Food and Drug Administration Pregnancy Categories

A. Controlled studies performed in pregnant women do not demonstrate a risk to the fetus during the first trimester of pregnancy with no evidence of risk in the second or third trimesters. The possibility of fetal harm appears highly unlikely.

B. Either studies in reproducing animals do not demonstrate a fetal risk but there are no controlled studies in pregnant women, or animal reproduction studies have shown adverse effects (other than a decrease in fertility) that were not confirmed in controlled studies in pregnant women in the first trimester and there is no evidence of a risk in later trimesters.

C. Either study in animals has demonstrated adverse effects on the fetus (teratogenic, embryocidal, or other effects) and there are no controlled studies in women, or studies in women and animals are not available. These drugs should be given only if the potential benefits of the drug justify the potential or unknown risk to the fetus.

D. There is positive evidence of human fetal risk, but the benefits from administration in pregnant women may be acceptable despite the risk. For example, if the drug is needed in a life-threatening situation or for a serious disease for which safer drugs cannot be used or are ineffective, administration may be indicated.

X. Animals or human studies have demonstrated fetal abnormalities or there is evidence of risk to the fetus based on human experience, or both. The risk of the use of the drug in pregnant women clearly outweighs any possible benefit. The drug is therefore contraindicated in women who are or may become pregnant.


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