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1 Cards in this Set
Pregnancy Category Ratings for Drugs (see other side for answers)
A system of classifying recommendations based on strength of the
supporting scientific evidence was used.
Class I This indicates that a treatment should be administered.
Class IIa This indicates that it is reasonable to administer treatment.
Class IIb This indicates that treatment may be considered.
Class III This indicates that treatment should NOT be administered.
It is not helpful and may be harmful.
Class Indeterminate This indicates that either research is beginning
on the treatment or that research is continuing on this treatment.
There are no recommendations until further research is performed
(eg, cannot recommend for or against).
AHA Classification of Recommendations
and Level of Evidence (See other side for answers)
Drugs have been categorized by the Food and Drug Administration
(FDA) according to the level of risk to the fetus.
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; the possibility of fetal harm appears to be remote.
Category B Either; (1) animal reproductive studies have not demonstrated a fetal risk but there are no controlled studies in women or, (2) animal reproductive studies have shown an adverse
effect (other than decreased fertility) that was not confirmed in controlled studies on women in the first trimester and there is no evidence of risk in later trimesters.
Category C Either; (1) studies in animals have revealed adverse effects on the fetus and there are no controlled studies in women or, (2) studies in women and animals are not available. Drugs in this
category should be given only if the potential benefit justifies the risk to the fetus.
Category D There is positive evidence of human fetal risk, but the benefits for pregnant women may be acceptable despite the risk, as in life-threatening diseases for which safer drugs cannot be used or
are ineffective. An appropriate statement must appear in the “Warnings” section of the labeling of drugs in this category.
Category X Studies in animals and humans have demonstrated fetal abnormalities, there is evidence of fetal risk based on human experience, or both; the risk of using the drug in pregnant women clearly outweighs any possible benefit. The drug is contraindicated in women who are or may become pregnant. An appropriate statement must appear in the “Contraindications” section of the labeling of drugs in this category.