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Index of Drug Safety in Pregnancy

An U.S. FDA categorization.

The FDA requires that all prescription drugs absorbed systemically or known to be potentially harmful to the fetus be classified according to one of five pregnancy categories (A, B, C, D, X). The identifying letter signifies the level of risk to the fetus and is to appear in the precautions section of the package insert.

"Category A" (safest) to "Category X" (known danger - do not use!)

The categories described by the FDA are as follows:

CATEGORY A Controlled studies in women fail to demonstrate a risk to the fetus in the first trimester (and there is no evidence of risk in later trimesters), and the possibility of fetal harm appears remote.

CATEGORY B Either animal-reproduction studies have not demonstrated a fetal risk but there are no controlled studies in pregnant women, or animal-reproduction studies have shown an adverse effect (other than a decrease in fertility) that was not confirmed in controlled studies in women in the first trimester (and there is no evidence of a risk in later trimesters).

CATEGORY C Either studies in animals have revealed adverse effects on the fetus (teratogenic or embryocidal effects or other) and there are no controlled studies in women, or studies in women and animals are not available. Drugs should be given only if the potential benefit justifies the potential risk to the fetus.

CATEGORY D There is positive evidence of human fetal risk, but the benefits from use in pregnant women may be acceptable despite the risk (e.g., 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). There will be an appropriate statement in the "warnings" section of the labeling.

CATEGORY X Studies in animals or human beings have demonstrated fetal abnormalities or there is evidence of fetal risk based on human experience, or both, and the risk of the use of the drug in pregnant women clearly outweighs any possible benefit. The drug is contraindicated in women who are or may become pregnant. There will be an appropriate statement in the "contraindications" section of the labeling.

 

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