Australia
Australia has a slightly different pregnancy category system from the United States - notably the subdivision of Category B. The system, as outlined below, was established by the Congenital Abnormalities Sub-committee of the Australian Drug Evaluation Committee (ADEC).
| ADEC Pregnancy Categories (Australia) | |
| Pregnancy Category A | Drugs that have been taken by a large number of pregnant women and women of childbearing age without an increase in the frequency of malformations or other direct or indirect harmful effects on the fetus having been observed. |
| Pregnancy Category B1 | Drugs that have been taken by only a limited number of pregnant women and women of childbearing age, without an increase in the frequency of malformation or other direct or indirect harmful effects on the human fetus having been observed. Studies in animals have not shown evidence of an increased occurrence of fetal damage. |
| Pregnancy Category B2 | Drugs that have been taken by only a limited number of pregnant women and women of childbearing age, without an increase in the frequency of malformation or other direct or indirect harmful effects on the human fetus having been observed. Studies in animals are inadequate or may be lacking, but available data show no evidence of an increased occurrence of fetal damage. |
| Pregnancy Category B3 | Drugs that have been taken by only a limited number of pregnant women and women of childbearing age, without an increase in the frequency of malformation or other direct or indirect harmful effects on the human fetus having been observed. Studies in animals have shown evidence of an increased occurrence of fetal damage, the significance of which is considered uncertain in humans. |
| Pregnancy Category C | Drugs that, owing to their pharmaceutical 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. |
| Pregnancy Category D | Drugs that 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. |
| Pregnancy Category X | Drugs that 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. |
The subcategorisation of Category B, while offering additional information that may be of benefit in evaluating the risk vs benefit, presents its own problem of data reliability - since human data is lacking or inadequate, the subcategorisation is based on animal data. Furthermore, allocation of a drug in Category B does not necessarily imply greater safety than Category C.
Drugs in Category D are not absolutely contraindicated in pregnancy, unlike those of Category X. In some cases, Category D was assigned to a drug on the basis of suspicion.
Read more about this topic: Pregnancy Category
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