Table 1 Definitions of the Australian categories for prescribing medicines in pregnancy [3]
From: Use of prescription medicines in Australian women of child-bearing age
Category A |
Drugs which have been taken by a large number of pregnant women and women of childbearing age without any proven increase in the frequency of malformations or other direct or indirect harmful effects on the fetus having been observed. |
Category B1 |
Drugs which 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. |
Category B2 |
Drugs which 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. |
Category B3 |
Drugs which 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. |
Category 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. Accompanying texts should be consulted for further details. |
Category 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. Accompanying texts should be consulted for further details. |
Category 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. |