Australian-TGA (Therapeutic Goods Administration) Pregnancy Risk Labeling

The Australian categorisation system for prescribing medicines in pregnancy

Definitions of the Australian categories for prescribing medicines in pregnancy (2)

What does the Australian categorisation system take into account?

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 categorisation system does not take into account the rare circumstance of an idiosyncratic reaction in the neonate to a medicine that crosses the placenta.

Situations for which the pregnancy category may not be valid

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):


Thus, a low dose, limited topical application of a medicine for a particular indication may have a less restrictive category (such as A) compared to a more restrictive category for the same medicine given long-term or at higher doses orally for a different indication.

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).


Due to legal considerations in Australia, sponsor companies have, in some cases, applied a more restrictive category than can be justified on the basis of the available data.


For pharmaceutical products containing two or more active ingredients, the categorisation of the combination is based on the active ingredient with the most restrictive pregnancy categorisation.

References

® 2023 EMDrugs. All rights reserved.

contact@emdrugs.com

DISCLAIMER

This website provides general information and discussion about medications, health, and related subjects. The words and other con­tent pro­vided in this website, and in any linked mate­ri­als, are not intended and should not be con­strued as med­ical advice. If the reader or any other per­son has a med­ical con­cern, he or she should con­sult with an appropriately-licensed physi­cian or other legally accredited health care worker in the country that resides or is visiting. 

 

Please do not delay your medical concerns and potential health emergencies by searching information in this website, instead look out for medical opinion in the services that exist with that specific purpose and work under the respective local health-care regulations. 

 

The views expressed on this blog and web­site have no rela­tion to those of any academic, hospital, practice or other insti­tu­tion with which the authors are  affiliated. 

 

For other instances, the authors of this website do not have any conflict of interest with any institution or pharmaceutical company in particular, and do not receive any compensation about any licenced drug mentioned in the website. In the same matter, the website is not intended to recommend any specific patented medication.


EMDrugs Team