Australian categorisation of drugs in pregnancy
Therapeutic Goods Administration (TGA) pregnancy categorisation is from the Prescribing medicines in pregnancy database at the TGA website.
In Therapeutic Guidelines, TGA pregnancy categories are included for dosage recommendations in the guidelines. The Toxicology and Toxinology and Palliative Care guidelines do not include specific advice or pregnancy categories for people who are pregnant or breastfeeding.
The pregnancy categorisation system only applies to recommended therapeutic doses. It cannot be assumed that the classifications assigned to individual medicines are valid in situations such as:
- overdose
- occupational exposure
- other situations in which the recommended therapeutic dose has been exceeded.
The categorisation of medicines for use in pregnancy does not follow a hierarchical structure.
- Human data are lacking or inadequate for drugs in the B1, B2 and B3 categories.
- Subcategorisation of the B category is based on animal data.
- The allocation of a B category does not imply greater safety than a C category.
- Medicines in category D are not absolutely contraindicated during pregnancy.
Because of 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.
The TGA pregnancy category should not be the sole basis of decision-making in the use of a drug during pregnancy, because it does not provide information about the balance of harms and benefits for a particular person and fetus. Furthermore, the category does not indicate the stage(s) of fetal development that might be affected by drug exposure and may not reflect the most up-to-date information about the drug's use in pregnancy.
TGA pregnancy categories are accessible through icons in the drug recommendations. 