Australian-TGA (Therapeutic Goods Administration) Pregnancy Risk Labeling
The Australian categorisation system for prescribing medicines in pregnancy
Introduction: the Australian categorisation system and database for prescribing medicines in pregnancy have been developed by medical and scientific experts based on available evidence of risks associated with taking particular medicines while pregnant. This information is presented for the use of health professionals prescribing medicines to pregnant women. It is not presented as medical advice to health professionals or the public (2).
This categorisation system when compared with other tools available within Australia, and also LactMed, has been found to be the more cautious information resource, with 44.5% of pregnancy recommendations and 69% of lactation recommendations reviewed being more conservative than other resources (1).
Definitions of the Australian categories for prescribing medicines in pregnancy (2)
Most medicines cross the placenta. The categorisation system has taken into account the known harmful effects of medicines on the developing baby, including the potential to cause (2):
The pregnancy categorisation system only applies to recommended therapeutic doses in women. It cannot be assumed that the classifications assigned to individual medicines are valid in situations such as (2):
Why do some products have more than one pregnancy category?
While some medicines are genuinely teratogenic, and carry a category X, for most medicines the risk of developing birth defects is also dependent on (2):
The Australian categorisation system is not hierarchical
The Australian categorisation system differs from the US FDA categorisation. The categorisation of medicines for use in pregnancy does not follow a hierarchical structure (2).
Brown E, Hotham E, Hotham N. Pregnancy and lactation advice: How does Australian Product Information compare with established information resources? Obstet Med. 2016 Sep;9(3):130-4. doi: 10.1177/1753495X16637750. Epub 2016 Apr 28. PMID: 27630750; PMCID: PMC5010117.
Pumed Central (Open Access)