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.


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