TGA category | |
(A) | Drugs taken by a large number of pregnant women, without an increase in the frequency of fetal malformations or harmful effects. |
(B1) | Drugs taken by a limited number of pregnant women, without an increase in the frequency of fetal malformation or harmful effects. Studies in animals have not shown evidence of increased fetal damage. |
(B2) | Drugs taken by a limited number of pregnant women, without an increase in the frequency of fetal malformation or harmful effects. Studies in animals are inadequate or may be lacking. |
(B3) | Drugs taken by a limited number of pregnant women, without an increase in the frequency of fetal malformation or harmful effects. Studies in animals have shown evidence of an increased occurrence of fetal damage, the significance of which is considered uncertain in humans. |
(C) | Drugs which, owing to their pharmacological effects, have caused or may be suspected of causing harmful effects on the human fetus or neonate without causing malformations. These effects may be reversible. |
(D) | Drugs which have caused, are suspected to have caused or may be expected to cause an increased incidence of human fetal malformations or irreversible damage. These drugs may also have adverse pharmacological effects. |
(X) | Drugs which have such a high risk of causing permanent damage to the fetus that they should not be used in pregnancy or when there is a possibility of pregnancy. |
(–) | Not assigned |
FDA category | |
[A] | Controlled studies in women fail to demonstrate a risk to the fetus in the first trimester (and there is no evidence of a risk in later trimesters) and the possibility of fetal harm appears remote. |
[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). |
[C] | Either studies in animals have revealed adverse effects on the fetus (teratogenic or embryocidal 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. |
[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). |
[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. |
[–] | Not assigned. |