A to X: the problem of categorisation of drugs in pregnancy — an Australian perspective

In reply: As a practising physician, Morton clearly understands the issues faced by prescribers and consumers regarding drug categorisation in pregnancy.1 Currently, the Therapeutic Goods Administration provides no references for the data on which it bases its drug categorisations for pregnancy. It is therefore left to the conscientious prescriber to try to find the data (not always easy or obvious) and then attempt to interpret it in a clinically relevant way. The more narrative approach suggested by Morton is an improvement but would still need clinical context and interpretation for optimal use.

The system proposed by the United States Food and Drug Administration (FDA) would provide appropriate referenced data so that clinicians and consumers could see the latest available evidence (and not, as Morton points out, just the limited studies performed up to 30 years ago) about the safety (or otherwise) of medication to enable rational decision making regarding medication use during pregnancy and breastfeeding.

The FDA’s proposed new labelling would include contact details of any pregnancy registries, if applicable, for the agent in question.2 At present, there are over 20 pregnancy registries collecting prospective data on the effects of exposures, including antiepileptic drugs and vaccines, as well as registries for pregnant women being treated for chronic medical conditions such as rheumatoid arthritis and HIV/AIDS.3

It is unfortunate that Australian regulators have not properly discussed these issues with interested professionals in the past few years. Even if we cannot remain world leaders in this field, it behoves us to at least embrace innovation occurring in other parts of the world.