Pregnancy Drug Categories

Pregnancy Drug Categories are classifications which indicate how safe medicines are for use by pregnant women. They are determined by scientific and medical experts under the authority of the Therapeutic Goods Administration, considering available evidence regarding how the medicines affect pregnant women and their foetuses.

Category A

Drugs which have been taken by a large number of pregnant women and women of child-bearing age, without any proven increase in the frequency of malformations or other direct or indirect harmful effects on the foetus having been observed.

Category B1

Drugs which have been taken by only a limited number of pregnant women and women of child-bearing age, without an increase in the frequency of malformation or other direct or indirect harmful effects on the human foetus having been observed. Studies in animals have not shown evidence of an increased occurrence of foetal damage.

Category B2

Drugs which have been taken by only a limited number of pregnant women and women of child-bearing age, without an increase in the frequency of malformation or other direct or indirect harmful effects on the human foetus having been observed. Studies in animals are inadequate or may be lacking, but available data show no evidence of an increased occurrence of foetal damage.

Category B3

Drugs which have been taken by only a limited number of pregnant women and women of child-bearing age, without an increase in the frequency of malformation or other direct or indirect harmful effects on the human foetus having been observed. Studies in animals have shown evidence of an increased occurrence of foetal 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 foetus or neonate without causing malformations. These effects may be reversible. Specialised 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 foetal malformations or irreversible damage. These drugs may also have adverse pharmacological effects. Specialised texts should be consulted for further details.

Category X

Drugs which have such a high risk of causing permanent damage to the foetus that they should not be used in pregnancy or when there is a possibility of pregnancy.

Reference

Australian Government Therapeutic Goods Administration. Australian Categorisation System for Prescribing Medicines in Pregnancy. 2011. [cited 3 January 2014] Available from: URL Link